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ABBVIE. BIOGEN AND ABBVIE ANNOUNCE THE VOLUNTARY WORLDWIDE WITHDRAWAL OF MARKETING AUTHORIZATIONS FOR ZINBRYTA® (DACLIZUMAB) FOR RELAPSING MULTIPLE SCLEROSIS. MAR 2, 2018.
ALLABOUTPHARMACOVIGILANCE.ORG. PERIODIC SAFETY UPDATE REPORTS (PSURS) / PERIODIC BENEFIT-RISK EVALUATION REPORTS (PBRER). ACCESSED : MAY 18, 2022.
ALLOUTPHARMACOVIGILANCE. DEVELOPMENT SAFETY UPDATE REPORT (DSUR). ACCESSED : MAY 18, 2022.
AMERICAN SOCIETY OF HEMATOLOGY (ASH). THROMBOSIS WITH THROMBOCYTOPENIA SYNDROME (ALSO TERMED VACCINE-INDUCED THROMBOTIC THROMBOCYTOPENIA). ACCESSED : DEC 16, 2021.
ANNOUNCED AND UNANNOUNCED INSPECTIONS
BIOLOGICAL INDICATOR (BI) PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. OCT 4, 2007.
CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS). HOME HEALTH QUALITY MEASURES. APR 14, 2022.
CTTI. LARGE SIMPLE TRIALS. OVERVIEW. ACCESSED : MAY 26, 2022.
DRUG-INDUCED DISEASES : PREVENTION, DETECTION AND MANAGEMENT. ACCESSED : DEC 4, 2022.
EMA. A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTICS (SMPC). SEP 2009.
EMA. ADVANCED THERAPY MEDICINAL PRODUCTS : OVERVIEW. ACCESSED : SEP 26, 2022.
EMA. CERVARIX. ACCESSSED : MAY 18, 2022.
EMA. DIRECT HEALTHCARE PROFESSIONAL COMMUNICATIONS|. ACCESSED : MAY 18, 2022.
EMA. ENCEPP. THE EUROPEAN NETWORK OF CENTRES FOR PHARMACOEPIDEMIOLOGY AND PHARMACOVIGILANCE (ENCEPP) GUIDE ON METHODOLOGY STANDARDS IN PHARMACOEPIDEMIOLOGY (REVISION 9). ACCESSED : JUN 2, 2022.
EMA. EUDRAVIGILANCE. ACCESSED : MAY 18, 2022.
EMA. GOOD PHARMACOVIGILANCE PRACTICES. ACCESSED : MAY 18, 2022.
EMA. GUIDELINE ON GVP. MODULE VI - COLLECTION, MANAGEMENT AND SUBMISSION OF REPORTS OF SUSPECTED ADVERSE REACTIONS TO MEDICINAL PRODUCTS (REV 2). JUL 2017.
EMA. GUIDELINE ON GVP MODULE XVI ADDENDUM I - EDUCATIONAL MATERIALS. ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE I - PHARMACOVIGILANCE SYSTEMS AND THEIR QUALITY SYSTEMS. ACCESSED : MAY 18, 2022.
EMA. GUIDELINE ON GVP. MODULE II - PHARMACOVIGILANCE SYSTEM MASTER FILE (REV 2). ACCESSED : MAY 18, 2022.
EMA. GUIDELINE ON GVP. MODULE III - PHARMACOVIGILANCE INSPECTIONS (REV 1). ACCESSED : MAY 19, 2022.
EMA. GUIDELINE ON GVP. MODULE IV - PHARMACOVIGILANCE AUDITS (REV. 1). ACCESSED : MAY 23, 2022.
EMA. GUIDELINE ON GVP. MODULE IX - SIGNAL MANAGEMENT (REV 1). ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE IX ADDENDUM I - METHODOLOGICAL ASPECTS OF SIGNAL DETECTION FROM SPONTANEOUS REPORTS OF SUSPECTED ADVERSE REACTIONS. ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE V - RISK MANAGEMENT SYSTEMS (REV 2). ACCESSED : MAY 19, 2022.
EMA. GUIDELINE ON GVP. MODULE VI ADDENDUM I - DUPLICATE MANAGEMENT OF SUSPECTED ADVERSE REACTION REPORTS. ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE VII - PERIODIC SAFETY UPDATE REPORT (REV 1). ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE VIII - POST-AUTHORISATION SAFETY STUDIES (REV 3). ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE VIII ADDENDUM I - REQUIREMENTS AND RECOMMENDATIONS FOR THE SUBMISSION OF INFORMATION NON-INTERVENTIONAL POST-AUTHORISATION SAFETY STUDIES (REV 3). ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE X - ADDITIONAL MONITORING. ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE XV - SAFETY COMMUNICATION (REV 1). ACCESSED : JUN 2, 2022.
EMA. GUIDELINE ON GVP. MODULE XVI - RISK MINIMISATION MEASURES : SELECTION OF TOOLS AND EFFECTIVENESS INDICATORS (REV 2). ACCESSED : JUN 2, 2022.
EMA. ICH TOPIC E2A. CLINICAL SAFETY DATA MANAGEMENT : DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING. MAY 24, 2022.
EMA. MEDICINES UNDER ADDITIONAL MONITORING. ACCESSED : JUN 1, 2022.
EMA. PATIENT REGISTRIES. ACCESSED : MAY 18, 2022.
EMA. PERIODIC SAFETY UPDATE REPORT (PSURS). ACCESSED : MAY 18, 2022.
EMA. PHARMACOVIGILANCE INSPECTION PROCEDURES : HUMAN. ACCESSED : MAY 19, 2022.
EMA. PRAC RECOMMENDATIONS ON SAFETY SIGNALS. ACCESSED : MAY 18, 2022.
EMA. PRODUCT-INFORMATION REQUIREMENTS. ACCESSED : MAY 19, 2022.
EMA. PUBLIC DATA FROM THE ARTICLE 57 DATABASE. ACCESSED : MAY 19, 2022.
EMA. SIGNAL MANAGEMENT. ACCESSED : MAY 18, 2022.
ESSLINGER S, QUINN L, SAMPAT S. ET AL. RISK MANAGEMENT PLANS: REASSESSMENT OF SAFETY CONCERNS BASED ON GOOD PHARMACOVIGILANCE PRACTICES MODULE V (REVISION 2)—A COMPANY EXPERIENCE. J PHARM HEALTH CARE SCI 8, 14 (2022).
EU EMA. ZIAGEN. ACCESSED : NOV 12, 2021.
EU. ABOUT INVESTIGATIONAL MEDICINAL PRODUCT DOSSIERS. ACCESSED : JUN 13, 2022.
EUPATI. ASPECTS OF PHARMACOVIGILANCE : PERIODIC SAFETY UPDATE REPORTS (PSURS). ACCESSED : JUN 13, 2022.
EUPATI. ASPECTS OF PHARMACOVIGILANCE. DEVELOPMENT SAFETY UPDATE REPORT (DSUR). ACCESSED : JUN 13, 2022.
EUPATI. GENERAL TOXICITY STUDIES. ACCESSED : APR 5, 2022.
EUPATI. TYPES OF STUDY IN EARLY CLINICAL DEVELOPMENT. ACCESSED : JUN 13, 2022.
GERMAN SOCIETY FOR EPIDEMIOLOGY (DGEPI). GOOD EPIDEMIOLOGIC PRACTICE (GEP). LONG VERSION. ACCESSED : JUN 2, 2022.
GLOBAL ANTIBIOTIC RESEARCH AND DEVELOPMENT PARTNERSHIP (GARDP)
GSK. GSK PROVIDES AN UPDATE ON BLENREP (BELANTAMAB MAFODOTIN-BLMF) US MARKETING AUTHORIZATION. NOV 22, 2022.
HANELL A, ROSTAMI EL. HOW CAN A PUNCH KNOW YOU OUT? FRONT NEUROL. 2020; 11: 570566.
HAYDEN EC. THEY CREATED A DRUG FOR SUSANNAH. WHAT ABOUT MILLIONS OF OTHER PATIENTS? DEC 19, 2022.
ICER HEMOPHILIA A AND B. AN ASSESSMENT OF GENE THERAPIES, INCLUDING ETRANACOGENE DEZAPARVOVEC AND VALOCTOGENE ROXAPARVOVEC. PUBLIC MEETING : NOV 2022.
ICER. ALZHEIMER’S DISEASE. AN ASSESSMENT OF DONANEMAB, LECANEMAB, AND ADUCANUMAB. PUBLIC MEETING : MAR 2023.
ICER. ALZHEIMER’S DISEASE. AN ASSESSMENT ON ADUCANUMAB. PUBLIC MEETING : JUL 2021.
ICER. AMYLOIDOSIS. A REVIEW OF INOTERSEN AND PATISIRAN FOR THE TREATMENT OF HEREDITARY TRANSTHYRETIN-RELATED (HATTR) AMYLOIDOSIS. PUBLIC MEETING. AUG 2018.
ICER. AMYOTROPHIC LATERAL SCLEROSIS (ALS). AN ASSESSMENT OF AMX0035 AND ORAL EDARAVONE. PUBLIC MEETING : AUG 2022.
ICER. ANEMIA IN CHRONIC KIDNEY DISEASE. AN ASSESSMENT OF ROXADUSTAT. PUBLIC MEETING. FEB 2021.
ICER. ASTHMA. AN ASSESSMENT OF BIOLOGICS FOR SEVERE ASTHMA. PUBLIC MEETING. NOV 2018.
ICER. ASTHMA. AN ASSESSMENT OF MEPOLIZUMAB. PUBLIC MEETING. FEB 2016.
ICER. ASTHMA. AN ASSESSMENT OF TEZEPELUMAB. PUBLIC MEETING : NOV 2021.
ICER. ATOPIC DERMATITIS. AN ASSESSMENT OF ABROCITINIB, TRALOKINUMAB, BARICITINIB, UPADACITINIB, AND RUXOLITINIB. PUBLIC MEETING : JUL 2021.
ICER. ATOPIC DERMATITIS. AN ASSESSMENT OF CRISABOROLE AND DUPILUMAB. PUBLIC MEETING. MAY 2017.
ICER. BETA THALASSEMIA. AN ASSESSMENT OF BETIBEGLOGENE AUTOTEMCEL. PUBLIC MEETING : JUN 2022.
ICER. BLADDER CANCER. AN ASSESSMENT OF NADOFARAGENE FIRADENOVEC AND OPORTUZUMAB MONATOX FOR BCG-UNRESPONSIVE, NON-MUSCLE INVASIVE BLADDER CANCER. PUBLIC MEETING. NOV 2020.
ICER. CARDIOVASCULAR DISEASE : ADDITIVE THERAPIES. PUBLIC MEETING. AUG 2019.
ICER. CHEMOTHERAPY-INDUCED NEUTROPENIA. AN ASSESSMENT OF PLINABULIN AND TRILACICLIB. ACCESSED : NOV 2, 2022.
ICER. CHRONIC PAIN : LOWER BACK AND NECK. AN ASSESSMENT OF COGNITIVE AND MIND-BODY THERAPIES FOR CHRONIC LOW BACK AND NECK PAIN. PUBLIC MEETING : OCT 2017.
ICER. COVID-19. AN ASSESSMENT OF COVID-19 TREATMENTS, INCLUDING REMDESIVIR. PUBLIC MEETING. JUL 2020.
ICER. COVID-19. SPECIAL ASSESSMENT OF OUTPATIENT TREATMENTS FOR COVID-19. PUBLIC MEETING : APR 2022.
ICER. CYSTIC FIBROSIS. AN ASSESSMENT OF SYNDEMKO, ORKAMBI, AND KALYDECO. PUBLIC MEETING. MAY 2018.
ICER. CYSTIC FIBROSIS. AN ASSESSMENT OF VERTEX’S CFTR MODULATORS : SYMDEKO, ORKAMBI, KALYDECO, AND TRIKAFTA. PUBLIC MEETING. AUG 2020.
ICER. DEPRESSION : TREATMENT-RESISTANT. AN ASSESSMENT OF ESKETAMINE FOR TREATMENT-RESISTANT DEPRESSION. PUBLIC MEETING. MAY 2019.
ICER. DIABETES : TYPE 1 AND TYPE 2. AN ASSESSMENT OF INSULIN. PUBLIC MEETING. FEB 2016.
ICER. DIABETES : TYPE 2. AN ASSESSMENT OF ORAL SEMAGLUTIDE FOR TYPE 2 DIABETES. PUBLIC MEETING. NOV 2019.
ICER. DIABETES : TYPE 2. AN ASSESSMENT OF TIRZEPATIDE. PUBLIC MEETING : JAN 2022.
ICER. DUCHENNE MUSCULAR DYSTROPHY. AN ASSESSMENT OF DEFLAZACORT, ETEPLIRSEN, AND GOLODIRSEN FOR THE TREATMENT OF DUCHENNE MUSCULAR DYSTROPHY. PUBLIC MEETING. JUL 2019.
ICER. ECMO. AN ASSESSMENT OF EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). PUBLIC MEETING. FEB 2016.
ICER. ENDOMETRIOSIS. AN ASSESSMENT OF ELAGOLIX FOR ENDOMETRIOSIS. PUBLIC MEETING. JUL 2018.
ICER. EVALUATING AND ADVANCING HEALTH TECHNOLOGY ASSESSMENT METHODS THAT SUPPORT HEALTH EQUITY. ACCESSED : NOV 1, 2022.
ICER. FAIR ACCESS : COVERAGE POLICIES IN 2022. ACCESSED : NOV 1, 2022.
ICER. HEMOPHILIA A. AN ASSESSMENT OF EMICIZIUMAB. PUBLIC MEETING. MAR 2018.
ICER. HEMOPHILIA A. AN ASSESSMENT OF VALOCTOCOGENE ROXAPARVOVEC AND EMICIZUMAB FOR THE TREATMENT OF HEMOPHILIA A. PUBLIC MEETING : OCT 2020.
ICER. HEREDITARY ANGIOEDEMA. AN ASSESSMENT OF LANADELUMAB AND TWO C1 ESTERASE INHIBITORS. ACCESSED : NOV 3, 2022.
ICER. HIGH CHOLESTEROL: PCSK9S. AN ASSESSMENT OF ALIROCUMAB (PRALUENT) AND EVOLUCUMAB (REPATHA) FOR THE TREATMENT OF HIGH SCHOLESTEROL; UPDATED IN 2019. PUBLIC MEETING. FEB 2019.
ICER. HIGH CHOLESTEROL. AN ASSESSMENT OF TREATMENTS FOR HIGH CHOLESTEROL. PUBLIC MEETING. FEB 2021.
ICER. HYPERTROPHIC CARDIOMYOPATHY. AN ASSESSMENT OF MAVACAMTEN. PUBLIC MEETING : OCT 2021.
ICER. LEUKEMIA AND LYMPHOMA. AN ASSESSMENT OF CAR-T THERAPIES (TISAGENLECLEUCEL AND AXICABTAGENE CLIOLEUCEL)
ICER. LUPUS NEPHRITIS. AN ASSESSMENT OF VOCLOSPORIN AND BELIMUMAB. PUBLIC MEETING. MAR 2021.
ICER. MENOPAUSE : VASOMOTOR SYMPTOMS. AN ASSESSMENT OF FEZOLINETANT FOR VASOMOTOR SYMPTOMS. PUBLIC MEETING : DEC 2022.
ICER. MIGRAINE : ACUTE AND CHRONIC THERAPIES. PUBLIC MEETING. JUN 2018.
ICER. MIGRAINE : ACUTE THERAPEUTICS. INCLUDES UBROGEPANT (UBRELVY), RIMEGEPANT (NURTEC), AND LASMIDITAN (REYVOW). PUBLIC MEETING. JAN 2020.
ICER. MULTIPLE MYELOMA. A CLASS REIVEW OF MULTIPLE MYELOMA TREATMENTS. PUBLIC MTG. MAY 2016.
ICER. MULTIPLE MYELOMA. AN ASSESSMENT OF IDECABTAGENE VICLEUCEL, CILTACABTAGENE AUTOLEUCEL, AND BELANTAMAB MAFODITIN. PUBLIC MEETING. APR 2021.
ICER. MULTIPLE SCLEROSIS : CIS, RRMS, AND SPMS. AN ASSESSMENT OF ORAL AND MONOCLONAL ANTIBODY TREATMENTS FOR RELAPSING FORMS OF MS. PUBLIC MEETING : JAN 2023.
ICER. MULTIPLE SCLEROSIS : RRMS AND PPMS. AN ASSESSMENT OF DISEASE MODIFYING THERAPIES FOR RELAPSING-REMITTING MULTIPLE SCLEROSIS. PUBLIC MEETING : FEB 2017.
ICER. MULTIPLE SCLEROSIS : SPMS. AN ASSESSMENT OF SIPONIMOD FOR THE TREATMENT OF SECONDARY PROGRESSIVE MULTIPLE SCLEROSIS. PUBLIC MEETING. MAY 2019.
ICER. MYASTHENIA GRAVIS. AN ASSESSMENT OF EFGARTIGIMOD AND ECULIZUMAB. PUBLIC MEETING : SEP 2021.
ICER. NON-ALCOHOLIC STEATOHEPATITIS. AN ASSESSMENT OF RESMETIROM AND OBETICHOLIC ACID FOR NASH. PUBLIC MEETING : APR 2023.
ICER. NON-SMALL CELL LUNG CANCER. AN ASSESSMENT OF TYROSINE KINASE INHIBITORS AND IMMUNOTHERAPIES TARGETING THE PROGRAMMED DEATH 1 (PD-1) RECEPTOR OR ITS LIGAND (PD-L1) FOR THE TREATMENT OF SMALL CELL LUNG CANCER. PUBLIC MTG. OCT 2016.
ICER. OBESITY MANAGEMENT. AN ASSESSMENT OF SUBCUTANEOUS SEMAGLUTIDE, PHENTERMINE/TOPIRAMATE, AND NALTREXONE/BUPROPION. PUBLIC MEETING : SEP 2022.
ICER. OPIOID EPIDEMIC : ABUSE DETERRENT OPIOIDS. AN ASSESSMENT OF ABUSE-DDETERRENT FORMULATIONS OF OPIOID MEDICATIONS (ADFS). PUBLIC MEETING. JUL 2017.
ICER. OPIOID EPIDEMIC : DIGITAL HEALTH TECHNOLOGIES. AN ASSESSMENT OF RESET-O, CONNECTIONS, AND DYNAMICARE FOR THE TREATMENT OF OPIOID USE DISORDER. PUBLIC MEETING. NOV 2020.
ICER. OPIOID EPIDEMIC : OPIOID USE DISORDER. AN ASSESSMENT OF EXTENDED-RELEASE OPIOID AGONISTS AND ANTAGONISTS FOR MEDICATION ASSISTED TREATMENT. NOV 2018.
ICER. OPIOID EPIDEMIC : SUPERVISED INJECTION FACILITIES (SIF). PUBLIC MEETING. DEC 2020.
ICER. OSTEOPOROSIS. AN ASSESSMENT OF ANABOLIC THERAPIES. PUBLIC MEETING. JUN 2017.
ICER. OVARIAN CANCER. AN ASSESSMENT OF POLY ADP-RIBOSE POLYMERASE (PARP) INHIBITORS. PUBLIC MEETING : SEP 2017.
ICER. PALLIATIVE CARE. AN ASSESSMENT OF PALLIATIVE CARE IN THE OUTPATIENT SETTING. PUBLIC MEETING. MAR 2016.
ICER. PEANUT ALLERGY. AN ASSESSMENT OF VIASKIN® PEANUT AND ORAL IMMUNOTHERAPY FOR PEANUT ALLERGY. PUBLIC MEETING. JUN 2019.
ICER. PRIMARY BILIARY COLANGITIS AND NON-ALCOHOLIC STEATOHEPATITIS. PUBLIC MTG. JUL 2016.
ICER. PROSTATE CANCER. AN ASSESSMENT OF ENZALUTAMIDE, ABIRATERONE ACETATE, AND APALUTAMIDE. PUBLIC MEETING. SEP 2018.
ICER. PSORIASIS. AN ASSESSMENT OF ANTI TNF AGENTS, ANTI IL-17A AGENTS, ANTI IL-12/23 AGENTS, AND AN ANTI PDE4 AGENT. PUBLIC MTG. NOV 2016.
ICER. PSORIASIS. AN ASSESSMENT OF GUSELKUMAB, TILDRAKIZUMAB, RISANKIZUMAB, AND CERTOLIZUMAB PEGOL. PUBLIC MEETING. JUL 2018.
ICER. RETINAL DISEASE. AN ASSESSMENT OF VORETIGENE NEPAROVEC. REVIEW : JAN 2018.
ICER. RHEUMATOID ARTHRITIS. A CLASS REVIEW OF TNF INHIBITORS, CD20-DIRECTED CYTOLYTIC ANTIBODIES, T-CELL INHIBITORS, IL-6 INHIBITORS, AND JAK INHIBITORS. PUBLIC MEETING. MAR 2017.
ICER. RHEUMATOID ARTHRITIS. AN ASSESSMENT OF JAK INHIBITORS. PUBLIC MEETING. DEC 2019.
ICER. SICKLE CELL DISEASE. AN ASSESSMENT OF CRIZANLIZUMAB, VOXELOTOR, AND L-GLUTAMINE FOR THE TREATMENT OF SICKLE CELL DISEASE. ACCESSED : NOV 5, 2022.
ICER. SPINAL MUSCULAR ATROPHY. AN ASSESSMENT OF ONASEMNOGENE ABEPARVOVEC AND NUSINERSEN FOR SPINAL MUCULAR ATROPHY (SMA). PUBLIC MEETING. MAR 2019.
ICER. TARDIVE DYSKINESIA. AN ASSESSMENT OF VALBENAZINE, DEUTETRABENAZINE, AND TETRABENAZINE. PUBLIC MEETING. DEC 2017.
ICER. ULCERATIVE COLITIS. AN ASSESSMENT OF TREATMENTS FOR ULCERATIVE COLITIS. PUBLIC MEETING. SEP 2020.
ICH. EFFICACY GUIDELINES. ACCESSED : JUN 13, 2022. (E1-CLINICAL SAFETY FOR DRUGS USED IN LONG-TERM TREATMENT, E2-PHARMACOVIGILANCE, E3-CLINICAL STUDY REPORTS, E4-DOSE-RESPONSE STUDIES, E5-ETHNIC FACTORS, E6-GOOD CLINICAL PRACTICE, E7-CLINICAL TRIALS IN GERIATRIC POPULATION, E8-GENERAL CONSIDERATIONS FOR CLINICAL TRIALS, E9-STATISTICAL PRINCIPLES FOR CLINICAL TRIALS, E10-CHOICE OF CONTROL GROUP IN CLINICAL TRIALS, E11-CLINICAL TRIALS IN PEDIATRIC POPULATION, E12-CLINICAL EVALUATION BY THERAPEUTIC CATEGORY (ANTIHYPERTENSIVE), E14-CLINICAL EVALUATION OF QT, E15-DEFINITIONS IN PHARMACOGENETICS AND PHARMACOGENOMICS, E16-QUALIFICATION OF GENOMIC BIOMARKERS, E17-MULTI-REGIONAL CLINICAL TRIALS, E18-GENOMIC SAMPLING, E19-SAFETY DATA COLLECTION, E20 ADAPTIVE CLINICAL TRIALS)
ICH. ICH GUIDELINES. ACCESSED : APR 5, 2022.
ICH. MULTIDISCIPLINARY GUIDELINES. ACCESSED : JUN 13, 2022. (M1-MEDDRA TERMINOLOGY, M2-ELECTRONIC STANDARDS, M3-NONCLINICAL SAFETY STUDIES, M4-COMMON TECHNICAL DOCUMENT, M5-DATA ELEMENTS AND STANDARDS FOR DRUG DICTIONARIES, M6-GENE THERAPY, M7-MUTAGENIC IMPURITIES, M8-ELECTRONIC CTD, M9-BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS, M10-BIOANALYTICAL MEETHOD VALIDATION AND STUDY SAMPLE ANALYSIS, M11-CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP), M12-DRUG INTERACTION STUDIES, M13-BIOEQUIVALENCE FOR IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORMS, M14-USE OF REAL-WORLD DATA IN PHARMACOEPIDEMIOLOGICAL STUDIES)
ICH. QUALITY GUIDELINES. ACCESSED : JUN 13, 2022. (Q1-STABILITY, Q2-ANALYTICAL VALIDATION, Q3-IMPURITIES, Q4-PHARMACOPOEIAS, Q5-QUALITY OF BIOTECHNOLOGICAL PRODUCTS, Q6-SPECIFICATIONS, Q7-GOOD MANUFACTURING PRACTICCE, Q8-PHARMACEUTICAL DEVELOPMENT, Q9-QUALITY RISK MANAGEMENT, Q10-PHARMACEUTICAL QUALITY SYSTEM, Q11-DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES, Q12-LIFECYCLE MANAGEMENT, Q13-CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS, Q14-ANALYTICAL PROCEDURE DEVELOPMENT)
ICH. SAFETY GUIDELINES. ACCESSED : JUN 13, 2022. (S1-CARCINOGENICITY STUDIES, S2-GENOTOXICITY STUDIES, S3-TOXICOKINETICS AND PHARMACOKINETICS, S4-TOXICITY TESTING, S5-REPRODUCTIVE TOXICOLOGY, S6-BIOTECHNOLOGICAL PRODUCTS, S7-PHARMACOLOGY STUDIES, S8-IMMUNOTOXICOLOGY STUDIES, S9-NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS, S10-PHOTOSAFETY EVALUATION, S11-NONCLINICAL PAEDIATRIC SAFETY, S12-NON-CLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS)
IOWA STATE UNIVERSITY. PISCINE MYCOBACTERIOSIS. ACCESSED : MAY 2, 2022.
ISO. ISO 10993-1:2018. BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1: EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS. JAN 9, 2022.
ISPE. GUIDELINES FOR GOOD PHARMACOEPIDEMIOLOGY PRACTICES (GPP). ACCESSED : JUN 2, 2022.
KARESH A. FDA. PEDIATRIC DRUG DEVELOPMENT : REGULATORY EXPECTATIONS. ACCESSED : JAN 2, 2022.
KOUNANG N, ET AL. CDC AND MASSACHUSETTS HEALTH OFFICIALS INVESTIGATING MONKEYPOX CASE. MAY 19, 2022.
LABCORP. POPULATION PK/PD ANALYSIS : WHAT, WHY, HOW, AND WHEN. ACCESSED : JUN 13, 2022.
LILLY. NEWS RELEASE. LILLY TO ESTABLISH AN ACCESS PROGRAM FOR PATIENTS AS IT PREPARES TO WITHDRAW LARTRUVO FROM THE GLOBAL MARKET. APR 25, 2019.
LIVERTOX. ADVERSE DRUG REACTION PROBABLY SCALE (NARANJO) IN DRUG INDUCED LIVER INJURY. ACCESSED : JUN 22, 2022.
LUPUS RESEARCH ALLIANCE. LUCIN FAQ. ACCESSED : APR 19, 2022.
MULTI-REGIONAL CLINICAL TRIALS (MRCT) AT HARVARD. CAUSALITY ASSESSMENT WORKSHOP FOR CLINICAL TRIAL INVESTIGATORS. 2014(?).
MUNOZ FM ET AL. VACCINE-ASSOCIATED ENAHNCED DISEASE: CASE DEFINITION AND GUIDELINES FOR DATA COLLECTION, ANALYSIS, AND PRESENTATION OF IMMUNIZATION SAFETY. VACCINE. 2021.
ONCOPEPTIDES. PRESS RELEASE. ONCOPEPTIDES WITHDRAWS PEPAXTO IN US, SCALE DOWN ORGANIZATION AND FOCUS ON R&D. OCT 22, 2021.
OXENDEN MK. WHAT TO DO IN A CROWD CRUSH. NEW YORK TIMES. DEC 31, 2022.
POST-AUTHORISATION INSPECTIONS
PRE-AUTHORISATION INSPECTIONS
RE-INSPECTIONS
REAGAN-UDALL FOUNDATION FOR THE FDA. EXPANDED ACCESS NAVIGATOR. ACCESSED : DEC 14, 2021.
REMOTE INSPECTIONS
ROUTINE AND “FOR CAUSE” PHARMACOVIGILANCE INSPECTIONS
SALAS M. DRUG UTILIZATION STUDIES. APR 2012. ACCESSED : MAY 26, 2022.
SJÖGREN’S FOUNDATION. SJÖGREN’S AWARENESS MONTH 2022. ACCESSED : APR 19, 2022.
SLEEP FOUNDATION. HYPNAGOGIC HALLUCINATIONS. ACCESSED : MAY 17, 2022.
SLEEP FOUNDATION. HYPNOPOMPIC HALLUCINATIONS. ACCESSED : MAY 17, 2022.
SLEEP FOUNDATION. WHAT YOU SHOULD KNOW ABOUT SLEEP PARALYSIS. ACCESSED : MAY 17, 2022.
SUN LH. INSIDE THE GLOBAL HUNT FOR A CULPRIT IN MYSTERIOUS HEPATITIS CASES. WASHINGTON POST. MAY 18, 2022.
SUN S, ET AL. PREDICTING REGULATORY PRODUCT APPROVALS USING A PROPOSED QUANTITATIVE VERSION OF FDA’S BENEFIT–RISK FRAMEWORK TO CALCULATE NET-BENEFIT SCORE AND BENEFIT–RISK RATIO. THERA INNOV REG SCI. 2021. 55: 129-137.
SYSTEM AND PRODUCT-RELATED INSPECTIONS
TG THERAPEUTICS. TG THERAPEUTICS ANNOUNCES VOLUNTARY WITHDRAWAL OF THE BLA/SNDA FOR U2 TO TREAT PATIENTS WITH CLL AND SLL. APR 15, 2022.
UPTODATE. LOCAL ANESTHETIC SYSTEMIC TOXICITY.
US AHRQ. PATIENT SAFETY ORGANIZATION PROGRAM. ACCESSED NOV 9, 2021.
US ASPR. DECLARATIONS OF A PUBLIC HEALTH EMERGENCY. ACCESSED : SEP 23, 2022.
US CDC-ATSDR. 1-BROMOPROPANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,1-DICHLOROETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,1-DICHLOROETHENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,1,1-TRICHLOROETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,1,2-TRICHLOROETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,1,2,2-TETRACHLOROETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,2-DIBROMO-3-CHLOROPROPANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,2-DIBROMOETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,2-DICHLOROETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,2-DICHLOROETHENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,2-DICHLOROPROPANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,2-DIPHENYLHYDRAZINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,2,3-TRICHLOROPROPANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,3 DINITROBENZENE & 1,3,5 TRINITROBENZENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,3-BUTADIENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 1,4-DIOXANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 2-BUTANONE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 2-BUTOXYETHANOL AND 2-BUTOXYETHANOL ACETATE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 2-HEXANONE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 2,3-BENZOFURAN. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 2,4-DICHLOROPHENOXYACETIC ACID (2,4-D). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 2,4,6-TRINITROTOLUENE (TNT). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 3,3'-DICHLOROBENZIDINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. 4,4'-METHYLENEDIANILINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.|
US CDC-ATSDR. 4,4'METHYLENEBIS(2-CHLOROANILINE) (MBOCA). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ACETONE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ACROLEIN. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ACRYLAMIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ACRYLONITRILE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ALDRIN/DIELDRIN. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ALUMINUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. AMERICIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. AMMONIA. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ANILINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ANTIMONY. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ARSENIC. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ARSINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ASBESTOS AND YOUR HEALTH. ACCESSED : APR 29, 2022.
US CDC-ATSDR. ASBESTOS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ATRAZINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BARIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BENZENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BENZIDINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BENZIDINES/AROMATIC AMINES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. BERYLLIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BIS(2-CHLOROETHYL) ETHER. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BIS(CHLOROMETHYL) ETHER. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BLISTER AGENTS HN-1HN-2HN-3 NITROGEN MUSTARDS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BLISTER AGENTS: LEWISITE (L), MUSTARD-LEWISITE MIXTURE (HL). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BLISTER AGENTS: SULFUR MUSTARD AGENT H/HD, SULFUR MUSTARD AGENT HT. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BORON. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BROMODICHLOROMETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BROMOFORM & DIBROMOCHLOROMETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. BROMOMETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CADMIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CALCIUM HYPOCHLORITE/SODIUM HYPOCHLORITE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CARBON DISULFIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CARBON MONOXIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CARBON TETRACHLORIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CESIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLORDANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLORDECONE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLORFENVINPHOS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLORINATED DIBENZO-P-DIOXINS (CDDS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLORINE DIOXIDE & CHLORITE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLORINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLOROBENZENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLORODIBENZOFURANS (CDFS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLOROETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLOROFORM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLOROMETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLOROPHENOLS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHLORPYRIFOS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CHROMIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. COAL ASH. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. COBALT. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. COPPER. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CREOSOTE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CRESOLS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CROTONALDEHYDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. CYANIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DDT, DDE, DDD. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DEET (N,N-DIETHYL-META-TOLUAMIDE). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DI-N-BUTYL PHTHALATE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DI-N-OCTYLPHTHALATE (DNOP). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DI(2-ETHYLHEXYL)PHTHALATE (DEHP). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DIAZINON. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DIBORANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DICHLOROBENZENES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DICHLOROPROPENES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DICHLORVOS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DIETHYL PHTHALATE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DIISOPROPYL METHYLPHOSPHONATE (DIMP). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DINITROCRESOLS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DINITROPHENOLS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DINITROTOLUENES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. DIOXINS, FURANS, PCBS (CONTAIN PHENYL RINGS OF CARBON ATOMS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. DISULFOTON. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ENDOSULFAN. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ENDRIN. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ETHION. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ETHYLBENZENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ETHYLENE DIBROMIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ETHYLENE GLYCOL. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ETHYLENE OXIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. FLUORIDES, HYDROGEN FLUORIDE, AND FLUORINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. FORMALDEHYDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. FUEL OILS / KEROSENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. GASOLINE, AUTOMOTIVE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. GLUTARALDEHYDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. GLYPHOSATE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.|
US CDC-ATSDR. GUTHION. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HEPTACHLOR/HEPTACHLOR EPOXIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HEXACHLOROBENZENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HEXACHLOROBUTADIENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HEXACHLOROCYCLOHEXANE (HCH). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HEXACHLOROCYCLOPENTADIENE (HCCPD). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HEXACHLOROETHANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HEXAMETHYLENE DIISOCYANATE (HDI). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HMX (OCTOGEN). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HYDRAULIC FLUIDS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HYDRAZINES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HYDROCARBONS (CONTAIN HYDROGEN AND CARBON ATOMS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. HYDROGEN CHLORIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HYDROGEN CYANIDE (HCN). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HYDROGEN FLUORIDE (HF). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HYDROGEN PEROXIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. HYDROGEN SULFIDE CARBONYL SULFIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. IODINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. IONIZING RADIATION. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ISOPHORONE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. JET FUELS JP-4 AND JP-7. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. JP-5, JP-8, AND JET A. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 9, 2022.
US CDC-ATSDR. LEAD. TOXIC SUBSTANCES PORTAL. ACCESSED : APR 29, 2022.
US CDC-ATSDR. MALATHION. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. MANGANESE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. MERCURY. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. METHOXYCHLOR. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. METHYL ISOCYANATE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. METHYL MERCAPTAN. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. METHYL PARATHION. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. METHYL TERT-BUTYL ETHER (MTBE). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. METHYLENE CHLORIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. MIREX. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. MOLYBDENUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. N-HEXANE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. N-NITROSODI-N-PROPYLAMINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. N-NITROSODIMETHYLAMINE (NDMA). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. N-NITROSODIPHENYLAMINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. NAPHTHALENE, 1-METHYLNAPTHALENE, 2-METHYLNAPTHALENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. NERVE AGENTS (GA, GB, GD, VX). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. NICKEL. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. NITRATE AND NITRITE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. NITROBENZENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. NITROGEN OXIDES. TOXIC SUBSTANCES PORTAL. ACCESSED : APR 29, 2022.
US CDC-ATSDR. NITROPHENOLS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ORGANOPHOSPHATES AND CARBAMATES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. OTTO FUEL II AND ITS COMPONENTS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PARATHION. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PENTACHLOROPHENOL. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PERCHLORATES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PERFLUOROALKYLS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PESTICIDES (CHEMICALS USED FOR KILLING PESTS, SUCH AS RODENTS, INSECTS, OR PLANTS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. PHENOL. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PHENOLS/PHENOXY ACIDS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. PHOSGENE OXIME. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PHOSGENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PHOSPHATE ESTER FLAME RETARDANTS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PHOSPHINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PHTHALATES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. PLUTONIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. POLYBROMINATED BIPHENYLS (PBBS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. POLYBROMINATED DIPHENYL ETHERS (PBDES). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. POLYCHLORINATED BIPHENYLS (PCBS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. POLYCYCLIC AROMATIC HYDROARBONS (PAHS). TOXIC SUBSTANCES PORTAL. ACCESSED : APR 29, 2022.
US CDC-ATSDR. POLYCYCLIC AROMATIC HYDROCARBONS (PAHS). ACCESSED : APR 29, 2022.
US CDC-ATSDR. POLYCYCLIC AROMATIC HYDROCARBONS (PAHS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PROPYLENE GLYCOL. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PYRETHRINS AND PYRETHROIDS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. PYRIDINE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. RADIONUCLIDES (RADIOACTIVE MATERIALS). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. RADIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. RADON. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. RDX (CYCLONITE). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. S,S,S-TRIBUTYL PHOSPHOROTRITHIOATE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. SELENIUM HEXAFLUORIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. SELENIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. SILICA. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. SILVER. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. SODIUM HYDROXIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. STODDARD SOLVENT. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. STRONTIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. STYRENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. SULFUR DIOXIDE. TOXIC SUBSTANCES PORTAL ACCESSED : MAY 10, 2022.
US CDC-ATSDR. SULFUR MUSTARD. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. SULFUR TRIOXIDE & SULFURIC ACID. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. SYNTHETIC VITREOUS FIBERS. ACCESSED : APR 29, 2022.
US CDC-ATSDR. TETRACHLOROETHYLENE (PERC). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TETRYL. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. THALLIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. THORIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TIN AND COMPOUNDS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TITANIUM TETRACHLORIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TOLUENE DIISOCYANATE METHYLENEDIPHENYL DIISOCYANATE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TOLUENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TOTAL PETROLEUM HYDROCARBONS (TPH). ACCESSED : APR 29, 2022.
US CDC-ATSDR. TOXAPHENE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TRICHLOROBENZENES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TRICHLOROETHYLENE (TCE). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. TUNGSTEN. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. UNIDENTIFIED CHEMICAL. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. URANIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. USED MINERAL-BASED CRANKCASE OIL. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. VANADIUM. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. VINYL ACETATE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. VINYL CHLORIDE. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. VOLATILE ORGANIC COMPOUNDS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.
US CDC-ATSDR. WARFARE AND TERRORISM AGENTS (USED IN ACTS OF WAR OR TERROR). TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 10, 2022.|
US CDC-ATSDR. WHITE PHOSPHORUS. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. XYLENES. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-ATSDR. ZINC. TOXIC SUBSTANCES PORTAL. ACCESSED : MAY 6, 2022.
US CDC-NCHS. ACCESS TO HEALTHCARE. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ACCIDENTS/UNINTENTIONAL INJURIES. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ADOLESCENT HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ADULT DAY SERVICES CENTERS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. AIDS AND HIV. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ALCOHOL USE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ALL INJURIES. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ALLERGIES AND HAY FEVER. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ALZHEIMER’S DISEASE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. AMBULATORY CARE (DOCTOR VISITS). FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ANEMIA. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ARTHRITIS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ASSAULT OR HOMICIDE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ASTHMA. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD). FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. BIRTH DEFECTS OR CONGENITAL ANOMALIES. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. BIRTHS AND NATALITY. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. BIRTHS-METHOD OF DELIVERY. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. BIRTHWEIGHT AND GESTATION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. BODY MEASUREMENTS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. BRONCHITIS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. CANCER. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. CEREBROVASCULAR DISEASE OR STROKE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. CHICKENPOX. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. CHILD HEALTH. ACCESSED : JUN 28, 2022.
US CDC-NCHS. CHOLESTEROL. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. CHRONIC LIVER DISEASE AND CIRRHOSIS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. CHRONIC SINUSITIS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. CIGARETTE SMOKING AND ELECTRONIC CIGARETTE USE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. CONTRACEPTIVE USE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. DEATHS AND MORTALITY. ACCESSED : JUN 29, 2022.
US CDC-NCHS. DEPRESSION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. DIABETES. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. DIET/NUTRITION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. DIGESTIVE DISEASES. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. DISABILITY AND FUNCTIONING. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. DRUG OVERDOSES. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ELECTRONIC MEDICAL RECORDS / ELECTRONIC HEALTH RECORDS (EMRS / EHRS). FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. EMERGENCY DEPARTMENT VISITS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. EXERCISE OR PHYSICAL ACTIVITY. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. GROWTH CHARTS. ACCESSED : JUN 28, 2022.
US CDC-NCHS. HEALTH EXPENDITURES. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HEALTH INSURANCE COVERAGE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HEALTH OF AMERICAN INDIAN OR ALASKA NATIVE POPULATION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HEALTH OF ASIAN OR PACIFIC ISLANDER POPULATION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HEALTH OF BLACK OR AFRICAN AMERICAN NON-HISPANIC POPULATION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HEALTH OF HISPANIC OR LATINO POPULATION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HEALTH OF MEXICAN AMERICAN POPULATION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HEALTH OF WHITE NON-HISPANIC POPULATION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HEART DISEASE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HOME HEALTH CARE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HOSPICE CARE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HOSPITAL UTILIZATION (IN NON-FEDERAL SHORT-STAY HOSPITALS). FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. HYPERTENSION. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ILLICIT DRUG USE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. INFANT HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. INFECTIOUS DISEASE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. INFERTILITY. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. INFLUENZA. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. KIDNEY DISEASE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. LEADING CAUSES OF DEATH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. MAMMOGRAPHY. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. MARRIAGE AND DIVORCE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. MEASLES, MUMPS, AND RUBELLA. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. MEN’S HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. MENTAL HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. MORTALITY STATISTICS. ACCESSED : JUN 29, 2022.
US CDC-NCHS. MULTIPLE BIRTHS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. NURSING HOME CARE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. OBESITY AND OVERWEIGHT. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. OLDER PERSON’S HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. ORAL AND DENTAL HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. OSTEOPOROSIS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. PAP TESTS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. PNEUMONIA. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. REPRODUCTIVE HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. RESIDENTIAL CARE COMMUNITIES. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. SEXUALLY TRANSMITTED DISEASES. FASTSTATS. ACCESSED : JUN 30, 2022.|
US CDC-NCHS. SLEEP HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. SUICIDE AND SELF-HARM INJURY. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. TEEN BIRTHS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. THERAPEUTIC DRUG USE. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. UNMARRIED CHILDBEARING. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. VIRAL HEPATITIS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. WHERE TO WRITE FOR VITAL RECORDS. ACCESSED : JUN 26, 2022.
US CDC-NCHS. WHOOPING COUGH OR PERTUSSIS. FASTSTATS. ACCESSED : JUN 30, 2022.
US CDC-NCHS. WOMEN’S HEALTH. FASTSTATS. ACCESSED : JUN 30, 2022.|
US CDC-NIOSH. 1,4-DIOXINE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. 2-BUTOXYETHANOL. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. ACRYLAMIDE. ACCESSED : APR 26, 2022.
US CDC-NIOSH. ACRYLONITRILE. ACCESSED : APR 26, 2022.
US CDC-NIOSH. AEROSOLS. ACCESSED : APR 26, 2022.
US CDC-NIOSH. AGRICULTURAL SAFETY. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. AMMONIA. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. ANTHROPOMETRY. ACCESSED : APR 26, 2022.
US CDC-NIOSH. ANTIMONY. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. ANTINEOPLASTIC AGENTS. ACCESSED : JUN 22, 2022.
US CDC-NIOSH. ARSENIC. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. ASBESTOS. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. ASPHALT EMISSIONS INCLUDING FUMES. ACCESSED : JUN 25, 2022.
US CDC-NIOSH. BENZENE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. BERYLLIUM. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. BICYCLE SADDLES AND REPRODUCTIVE HEALTH. ACCESSED : JUN 26, 2022.
US CDC-NIOSH. CADMIUM. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. CARBON DISULFIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. CARBON MONOXIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. CHEMICALS : MANAGING CHEMICAL SAFETY IN THE WORKPLACE. ACCESSED : JUN 28, 2022.
US CDC-NIOSH. CHILDHOOD AGRICULTURAL INJURY PREVENTION INITIATIVE. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. CHLORINE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. CHLOROFORM. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. CHROMIUM. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. COBALT. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. COMMERCIAL FISHING SAFETY. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. CONFINED SPACES. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. DECPRESSION SICKNESS AND TUNNEL WORKERS. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. DIMETHYLFORMAMIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. DIRECTORY OF CONSTRUCTION RESOURCES. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. DISASTER SITE MANAGEMENT. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. DISTRACTED DRIVING AT WORK. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. DRIVER FATIGUE ON THE JOB. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. DRYCLEANING. ACCESSED : JUN 30, 2022.
US CDC-NIOSH. EMERGENCY RESPONDERS. ACCESSED : JUN 30, 2022.
US CDC-NIOSH. EMF (ELECTRIC AND MAGNETIC FIELDS). ACCESSED : JUN 30, 2022.
US CDC-NIOSH. ETHYLENE GLYCOL. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. ETHYLENE OXIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. FATALITY ASSESSMENT AND CONTROL EVALUATION (FACE) PROGRAM. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. FENTANYL. ACCESSED : JUL 1, 2022.
US CDC-NIOSH. FIBROUS GLASS. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. FIRE FIGHTER FATALITY INVESTIGATION AND PREVENTION PROGRAM. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. FLAVORINGS RELATED LUNG DISEASE. ACCESSED : JUL 1, 2022.
US CDC-NIOSH. FORMALDEHYDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HEALTHCARE WORKERS. ACCESSED : JUN 30, 2022.
US CDC-NIOSH. HEXAVALENT CHROMIUM. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HIGHWAY WORK ZONE SAFETY. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. HYDDROGEN FLUORIDE / HYDROFLUORIC ACID : SYSTEMIC AGENT. EMERGENCY RESPONSE CARD. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HYDRAZINE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HYDROGEN CHLORIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HYDROGEN CYANIDE (AC) : SYSTEMIC AGENT. EMERGENCY RESPONSE CARD. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HYDROGEN CYANIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HYDROGEN PEROXIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HYDROGEN SULFIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. HYDROQUINONE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. ISOCYANATES. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. LAW ENFORCEMENT OFFICER MOTOR VEHICLE SAFETY. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. LEAD. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. LONG-HAUL TRUCK DRIVERS. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. MACHINE SAFETY. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. MANGANESE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. MERCURY. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. METALWORKING FLUIDS. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. METHYL ALCOHOL (METHANOL). ACCESSED : MAY 5, 2022.
US CDC-NIOSH. METHYL ETHYL KETONE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. METHYLENE CHLORIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. MOTOR VEHICLE SAFETY AT WORK. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. NICKEL. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. NITROGEN MUSTARD HN-1 : BLISTER AGENT. ACCESSED : MAY 7, 2022.
US CDC-NIOSH. NOISE AND HEARING LOSS PREVENTION. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. OLDER DRIVERS AT WORK. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. ORGANIC SOLVENTS. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. ORTHO-TOLUIDINE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. OZONE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. PER- AND POLYFLUROALKYL SUBSTANCES (PFAS). ACCESSED : MAY 5, 2022.
US CDC-NIOSH. PESTICIDE ILLNESS AND INJURY SURVEILLANCE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. PHENOL. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. PHOSGENE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. PHOSPHINE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. PNEUMOCONIOSIS. ACCESSED : JUN 26, 2022.
US CDC-NIOSH. PROTECTIVE CLOTHING AND ENSEMBLES. ACCESSED : JUN 28, 2022.
US CDC-NIOSH. RHABDOMYOLYSIS. ACCESSED : JUN 3, 2022.
US CDC-NIOSH. SODIUM HYDROXIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. STYRENE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. SULFUR DIOXIDE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. SULFURIC ACID. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. TOLUENE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. TRENCHING AND EXCAVATION. ACCESSED : JUN 29, 2022.
US CDC-NIOSH. TRICHLOROETHYLENE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. VERMICULITE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. WORK-RELATED ASTHMA. ACCESSED : JUN 25, 2022.
US CDC-NIOSH. XYLENE. ACCESSED : MAY 5, 2022.
US CDC-NIOSH. YOUNG DRIVERS AT WORK. ACCESSED : JUN 29, 2022.
US CDC. INFORMATION FOR PARENTS OF INFANTS & TODDLERS (APPROXIMATE AGES 0-3). ACCESSED : JUN 25, 2022.
US CDC. (IQIP) IMMUNIZATION QUALITY IMPROVEMENT FOR PROVIDERS. ACCESSED : APR 29, 2022.
US CDC. 2019 ANTIBIOTIC-RESISTANT THREATS REPORT. ACCESSED : JUN 22, 2022.
US CDC. 3-QUINUCLIDINYL BENZILATE (BZ). EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. ABRASIVE BLASTING. ACCESSED : APR 26, 2022.
US CDC. ABRIN. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. ACANTHAMOEBA - GRANULOMATOUS AMEBIC ENCEPHALITIS (GAE), KERATITIS. ACCESSED : APR 26, 2022.
US CDC. ACANTHOCEPHALIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. ACINETOBACTER IN HEALTHCARE SETTINGS. ACCESSED : APR 26, 2022.
US CDC. ACUTE FLACCID MYELITIS (AFM). ACCESSED : APR 26, 2022.
US CDC. ADAMSITE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. ADENOVIRUS VIS. ACCESSED : APR 28, 2022.
US CDC. ADENOVIRUSES. ACCESSED : APR 26, 2022.
US CDC. ADJUVANTS AND VACCINES. ACCESSED : AUG 8, 2022.
US CDC. ADOLESCENT AN SCHOOL HEALTH. ACCESSED : APR 29, 2022.
US CDC. ADULT IMMUNIZATION SCHEDULE. ACCESSED : APR 29, 2022.
US CDC. ADVANCED MOLECULAR DETECTION (AMD). ACCESSED : APR 26, 2022.
US CDC. ADVERSE CHILDHOOD EXPERIENCES (ACE). ACCESSED : APR 26, 2022.
US CDC. ADVISORY COMMITTEE ON IMMUNIZATION PRACTICES (ACIP). ACCESSED : APR 26, 2022.
US CDC. AGING IN THE WORKPLACE. ACCESSED : APR 26, 2022.
US CDC. AIR POLLUTANTS. ACCESSED : APR 26, 2022.
US CDC. AIR QUALITY. ACCESSED : APR 29, 2022.
US CDC. ALCOHOL AND CAFFEINE. ACCESSED : APR 30, 2022.
US CDC. ALKHURMA HEMORRHAGIC FEVER (AHF). ACCESSED : APR 26, 2022.
US CDC. ALZHEIMER’S DISEASE AND HEALTHY AGING. ACCESSED : APR 26, 2022.
US CDC. AMEBIASIS - ENTAMOEBA HISTOLYTICA INFECTION. ACCESSED : APR 26, 2022.
US CDC. AMEBIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. AMERICAN TRYPANOSOMIASIS (ALSO KNOWN AS CHAGAS DISEASE). ACCESSED : APR 26, 2022.
US CDC. AMERICAN TRYPANOSOMIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. AMMONIA. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. ANAPLASMOSIS. ACCESSED : APR 26, 2022.
US CDC. ANATRICHOSOMIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. ANGIOSTRONGYLIASIS (ALSO KNOWN AS ANGIOSTRONGYLUS INFECTION). ACCESSED : APR 26, 2022.
US CDC. ANGIOSTRONGYLIASIS, ABDOMINAL. DPDX. ACCESSED : MAY 2, 2022.
US CDC. ANGIOSTRONGYLIASIS, NEURAL. DPDX. ACCESSED : MAY 2, 2022.
US CDC. ANISAKIASIS. ACCESSED : MAY 5, 2022.
US CDC. ANISAKIASIS. DPDX. ACCESSED : APR 26, 2022.
US CDC. ANTHRAX ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. ANTHRAX VACCINATION. ACCESSED : APR 26, 2022.
US CDC. ANTHRAX VIS. ACCESSED : APR 28, 2022.
US CDC. ANTHRAX. ACCESSED : APR 28, 2022.
US CDC. ANTIBIOTIC / ANTIMICROBIAL RESISTANCE. ACCESSED : MAY 5, 2022.
US CDC. ANTIBIOTIC PRESCRIBING AND USE. ACCESSED : MAY 5, 2022.
US CDC. AORTIC ANEURYSM. ACCESSED : OCT 7, 2024.
US CDC. ARENAVIRUSES (ARENAVIRIDAE). ACCESSED : JUL 1, 2022.
US CDC. ARSENIC. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. ARSINE (SA) OR STIBINE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. ARTHRITIS. ACCESSED : APR 26, 2022.
US CDC. ASCARIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. ASPERGILLOSIS. ACCESSED : JUN 25, 2022.
US CDC. ASSESSING YOUR WEIGHT. ACCESSED : JUN 25, 2022.
US CDC. ASSISTED REPRODUCTIVE TECHNOLOGY (ART). ACCESSED : JUN 22, 2022.
US CDC. ASTHMA & COMMUNITY HEALTH. ACCESSED : JUN 25, 2022.
US CDC. ASTHMA. ACCESSED : JUN 25, 2022.
US CDC. ATRIAL FIBRILLATION. ACCESSED : APR 26, 2022.
US CDC. ATTENTION DEFICIT/HYPERACTIVITY DISORDER (ADHD). ACCESSED : APR 26, 2022.
US CDC. AUTISM SPECTRUM DISORDER (ASD). ACCESSED : JUN 25, 2022.
US CDC. AVIATION SAFETY RESEARCH PROGRAM. ACCESSED : JUN 25, 2022.
US CDC. B VIRUS (HERPES B, MONKEY B VIRUS, HERPESVIRUS SIMIAE, AND HERPESVIRUS B). ACCESSED : MAY 1, 2022.
US CDC. BABESIOSIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. BACTERIAL MENINGITIS. ACCESSED : JUN 25, 2022.
US CDC. BACTERIAL VAGINOSIS (BV). ACCESSED : JUN 25, 2022.
US CDC. BALAMUTHIA MANDRILLARIS - GRANULOMATOUS AMEBIC ENCEPHALITIS (GAE). ACCESSED : MAY 2, 2022.
US CDC. BALANTIDIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. BARIUM. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. BARTONELLA BACILLIFORMIS INFECTION. ACCESSED : JUN 25, 2022.
US CDC. BARTONELLA INFECTION. ACCESSED : JUN 25, 2022.
US CDC. BARTONELLA QUINTANA INFECTION. ACCESSED : JUN 25, 2022.
US CDC. BAT INFLUENZA (FLU). ACCESSED : JUN 25, 2022.
US CDC. BAYLISASCARIS INFECTION. ACCESSED : MAY 1, 2022.
US CDC. BCG ACIP VACCINE RECOMMENDATIONS. APR 27, 2022.
US CDC. BED BUGS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. BENZENE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. BERTIELLA INFECTION. DPDX. ACCESSED : MAY 2, 2022.
US CDC. BICYCLE SAFETY. ACCESSED : JUN 29, 2022.
US CDC. BINGE DRINKING. ACCESSED : APR 30, 2021.
US CDC. BIOTERRORISM. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : JUN 26, 2022.
US CDC. BIRDS KEPT AS PETS. ACCESSED : MAY 1, 2022.
US CDC. BIRTH DEFECTS. ACCESSED : JUN 26, 2022.
US CDC. BLASTOCYSTIS SP. DPDX. ACCESSED : MAY 2, 2022.
US CDC. BLASTOMYCOSIS. ACCESSED : JUN 26, 2022.
US CDC. BLEEDING DISORDERS IN WOMEN. ACCESSED : JUN 26, 2022.
US CDC. BLISTER AGENTS / VESICANTS. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. BLOOD AGENTS. ACCESSED : MAY 5, 2022.
US CDC. BLOOD DISORDERS. ACCESSED : JUN 26, 2022.
US CDC. BLOOD SAFETY. ACCESSED : JUN 26, 2022.
US CDC. BOTSWANA. ACCESSED : JUN 26, 2022.
US CDC. BOTULISM. ACCESSED : JUN 26, 2022.
US CDC. BOURBON VIRUS. ACCESSED : JUN 26, 2022.
US CDC. BOVINE SPONGIFORM ENCEPHALOPATHY (BSE), OR MAD COW DISEASE. ACCESSED : MAY 1, 2022.
US CDC. BRAINERED DIARRHEA. ACCESSED : JUN 26, 2022.
US CDC. BREAST CANCER. ACCESSED : JUN 26, 2022.
US CDC. BREASTFEEDING. ACCESSED : JUN 26, 2022.
US CDC. BREVETOXIN. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. BROMINE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. BRUCELLOSIS. ACCESSED : MAY 1, 2022.
US CDC. BUNYAVIRALES. ACCESSED : JUN 26, 2022.
US CDC. C. GATTII INFECTION. ACCESSED : MAY 2, 2022.
US CDC. C. NEOFORMANS INFECTION. ACCESSED : MAY 1, 2022.
US CDC. CACHE VALLEY VIRUS. ACCESSED : JUN 26, 2022.
US CDC. CAMPYLOBACTER (CAMPYLOBACTERIOSIS). ACCESSED : MAY 1, 2022.
US CDC. CANCER CLUSTERS. ACCESSED : JUN 26, 2022.
US CDC. CANCER SURVIVORS. ACCESSED : JUN 26, 2022.
US CDC. CANCER. ACCESSED : JUN 26, 2022.
US CDC. CANDIDA AURIS. ACCESSED : JUN 26, 2022.
US CDC. CANDIDIASIS. ACCESSED : JUN 30, 2022.
US CDC. CANINE INFLUENZA (DOG FLU). ACCESSED : JUN 26, 2022.
US CDC. CAPNOCYTOPHAGA. ACCESSED : MAY 1, 2022.
US CDC. CARBON MONOXIDE POISONING AFTER A DISASTER. ACCESSED : MAY 5, 2022.
US CDC. CARBON MONOXIDE POISONING. ACCESSED : JUN 27, 2022.
US CDC. CARBON MONOXIDE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. CARDIOMYOPATHY. ACCESSED : JUN 27, 2022.
US CDC. CAREGIVING. ALZHEIMER’S DISEASE AND HEALTHY AGING. ACCESSED : JUN 27, 2022.
US CDC. CARING FOR CHILDREN IN A DISASTER. ACCESSED : JUN 29, 2022.
US CDC. CAT SCRATCH DISEASE. ACCESSED : MAY 1, 2022.
US CDC. CATHETER-ASSOCIATED URINARY TRACT INFECTIONS (CAUTI). HEALTHCARE-ASSOCIATED INFECTION. ACCESSED : JUN 28, 2022.
US CDC. CATS. ACCESSED : MAY 1, 2022.
US CDC. CAUSTICS (ACIDS, CORROSIVE AGENTS). EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. CDC ABORTION SURVEILLANCE SYSTEM FAQS. ACCESSED : OCT 7, 2024.
US CDC. CDC FEDERAL ADVISORY COMMITTEES (FAC). ACCESSED : APR 29, 2022.
US CDC. CDC IN ANGOLA. ACCESSED : JUN 22, 2022.
US CDC. CDC IN CONGO (REPUBLIC OF). ACCESSED : JUN 29, 2022.
US CDC. CDC IN COTE D’IVOIRE. ACCESSED : JUN 29, 2022.
US CDC. CELLULITIS : ALL YOU NEED TO KNOW. ACCESSED : JUN 30, 2022.
US CDC. CERCARIAL DERMATITIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. CEREBRAL PALSY (CP). ACCESSED : JUN 28, 2022.
US CDC. CERVICAL CANCER. ACCESSED : JUN 26, 2022.
US CDC. CHAPARE HEMORRHAGIC FEVER (CHHF). ACCESSED : JUN 28, 2022.
US CDC. CHEMICAL EMERGENCIES. ACCESSED : APR 29, 2022.
US CDC. CHEMICAL WEAPONS ELIMINATION. ACCESSED : JUN 28, 2022.
US CDC. CHEST COLD (ACUTE BRONCHITIS). ANTIBIOTIC PRESCRIBING AND USE. ACCESSED : JUN 26, 2022.
US CDC. CHEST RADIOGRAPHY. ACCESSED : JUN 28, 2022.
US CDC. CHICKENPOX (VARICELLA). ACCESSED : JUN 28, 2022.
US CDC. CHICKENPOX / VARICELLA VACCINATION. ACCESSED : APR 28, 2022.
US CDC. CHICKENPOX VIS. ACCESSED : APR 28, 2022.
US CDC. CHIKUNGUNYA VIRUS. ACCESSED : JUN 28, 2022.
US CDC. CHILD ABUSE AND NEGLECT PREVENTION. ACCESSED : OCT 7, 2024.
US CDC. CHILD AND ADOLESCENT IMMUNIZATION SCHEDULE. ACCESSED : APR 29, 2022.
US CDC. CHILD DEVELOPMENT. ACCESSED : JUN 28, 2022.
US CDC. CHILD PASSENGER SAFETY. ACCESSED : JUN 28, 2022.
US CDC. CHILDHOOD ARTHRITIS. ACCESSED : APR 26, 2022.
US CDC. CHILDHOOD OVERWEIGHT AND OBESITY. ACCESSED : JUN 28, 2022.
US CDC. CHILOMASTIX MESNILI. DPDX. ACCESSED : MAY 2, 2022.
US CDC. CHLAMYDIA PNEUMONIAE INFECTION. ACCESSED : JUN 28, 2022.
US CDC. CHLAMYDIA. ACCESSED : JUN 28, 2022.
US CDC. CHLORINE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. CHOLERA - VIBRIO CHOLERAE INFECTION. ACCESSED : JUN 28, 2022.
US CDC. CHOLERA ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. CHOLERA VIS. ACCESSED : APR 28, 2022.
US CDC. CHOLESTEROL. ACCESSED : JUN 28, 2022.
US CDC. CHROMIUM. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. CHRONIC DISEASE INDICATORS. ACCESSED : JUN 28, 2022.
US CDC. CHRONIC KIDNEY DISEASE INITIATIVE. ACCESSED : JUN 28, 2022.
US CDC. CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD). ACCESSED : JUN 28, 2022.
US CDC. CHRONIC WASTING DISEASE (CWD). ACCESSED : MAY 1, 2022.
US CDC. CLONORCHIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. COENUROSIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. COLCHICINE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. COLD STRESS. ACCESSED : JUN 29, 2022.
US CDC. COLD VERSUS FLU. ACCESSED : JUN 29, 2022.
US CDC. COLORADO TICK FEVER. ACCESSED : JUN 29, 2022.
US CDC. COLORECTAL (COLON) CANCER. ACCESSED : JUN 26, 2022.
US CDC. COLORECTAL CANCER CONTROL PROGRAM (CRCCP). ACCESSED : JUN 29, 2022.
US CDC. COMMERCIALLY BOTTLED WATER. ACCESSED : JUN 26, 2022.
US CDC. COMMON COLDS : PROTECT YOURSELF AND OTHERS. ACCESSED : JUN 29, 2022.
US CDC. CONDOM EFFECTIVENESS. ACCESSED : JUN 29, 2022.
US CDC. CONGENITAL HEART DEFECTS (CHDS). ACCESSED : JUN 29, 2022.
US CDC. CONJUNCTIVITIS (PINK EYE). ACCESSED : JUN 29, 2022.
US CDC. CONTRACEPTION. ACCESSED : JUN 26, 2022.
US CDC. COPING WITH A DISASTER OR TRAUMATIC EVENT. ACCESSED : JUN 29, 2022.
US CDC. CORRECTIONAL HEALTH. ACCESSED : JUN 29, 2022.
US CDC. COVID-19 ACIP VACCINE RECOMMENDATIONS. APR 27, 2022.
US CDC. COVID-19. ACCESSED : JUN 29, 2022.
US CDC. COVID-19. NUCLEIC ACID AMPLIFICATION TESTS (NAATS). ACCESSED : MAY 24, 2022.
US CDC. CREUTZFELDT-JAKOB DISEASE, CLASSIC (CJD). ACCESSED : MAY 1, 2022.
US CDC. CRIMEAN-CONGO HEMORRHAGIC FEVER (CCHF). ACCESSED : JUN 28, 2022.
US CDC. CRISIS AND EMERGENCY RISK COMMUNICATION (CERC). ACCESSED : JUN 28, 2022.
US CDC. CRONOBACTER. ACCESSED : MAY 17, 2022.
US CDC. CRYPTOSPORIDIOSIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. CRYPTOSPORIDIUM (ALSO KNOWN AS “CRYPTO”). ACCESSED : MAY 2, 2022.
US CDC. CRYSTALLINE SILICA. ACCESSED : MAY 5, 2022.
US CDC. CYANIDE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. CYCLOSPORIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. CYSTICERCOSIS. ACCESSED : MAY 2, 2022.
US CDC. CYSTICERCOSIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. CYSTOISOSPORIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. CYTOMEGALOVIRUS (CMV) AND CONGENITAL CMV INFECTION. ACCESSED : JUN 29, 2022.
US CDC. DENGUE ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. DENGUE VACCINATION. ACCESSED : APR 28, 2022.
US CDC. DENGUE VACCINE VIS. ACCESSED : APR 28, 2022.
US CDC. DENGUE. ACCESSED : JUN 29, 2022.
US CDC. DEVELOPMENTAL DISABILITIES. ACCESSED : JUN 29, 2022.
US CDC. DIABETES. ACCESSED : JUN 29, 2022.
US CDC. DIALYSIS SAFETY. ACCESSED : JUN 29, 2022.
US CDC. DICROCOELIASIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. DIENTAMOEBA FRAGILIS INFECTION. DPDX. ACCESSED : MAY 3, 2022.
US CDC. DIGITALIS. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. DIOCTOPHYMIASIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. DIPHTHERIA VACCINATION. ACCESSED : APR 28, 2022.
US CDC. DIPHYLLOBOTHRIASIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. DIPYLIDIUM CANINUM. DPDX. ACCESSED : MAY 3, 2022.
US CDC. DIPYLIDIUM INFECTION (ALSO KNOWN AS DOG AND CAT FLEA TAPEWORM). ACCESSED : MAY 2, 2022.
US CDC. DIROFILARIASIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. DISABILITY AND HEALTH PROMOTION. ACCESSED : JUN 29, 2022.
US CDC. DISASTER SCIENCE RESPONDER RESEARCH PROGRAM. ACCESSED : JUN 29, 2022.
US CDC. DOGS. ACCESSED : MAY 1, 2022.
US CDC. DRACUNCULIASIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. DRINKING WATER. ACCESSED : JUN 30, 2022.
US CDC. DRUG OVERDOSE. US CDC. DRINKING WATER. ACCESSED : JUN 30, 2022.
US CDC. DTAP (DIPHTHERIA, TETANUS, PERTUSSIS) VIS. ACCESSED : APR 28, 2022.
US CDC. DTAP / IPV / HIB / HEPB ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. DTAP / TDAP / TD ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. E. COLI (ESCHERICHIA COLI). ACCESSED : JUN 30, 2022.
US CDC. E. COLI INFECTION. ACCESSED : MAY 2, 2022.
US CDC. EAR INFECTION. ACCESSED : JUN 30, 2022.
US CDC. EARTHQUAKES. ACCESSED : JUN 30, 2022.
US CDC. EASTERN EQUINE ENCEPHALITIS VIRUS. ACCESSED : JUN 30, 2022.
US CDC. EBOLA (EBOLA VIRUS DISEASE). ACCESSED : JUN 30, 2022.
US CDC. ECHINOCOCCOSIS. ACCESSED : MAY 2, 2022.
US CDC. ECHINOCOCCOSIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. ECHINOSTOMIASIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. EGYPT. ACCESSED : JUN 30, 2022.
US CDC. EHLICHIOSIS. ACCESSED : JUN 30, 2022.
US CDC. ELDER ABUSE. ACCESSED : APR 26, 2022.
US CDC. ELECTRICAL SAFETY. ACCESSED : JUN 29, 2022.
US CDC. ELECTRONIC CASE REPORTING (ECR). ACCESSED : JUN 30, 2022.
US CDC. ELECTRONIC CIGARETTES. ACCESSED : JUN 30, 2022.
US CDC. ELECTRONIC LABORATORY REPORTING (ELR). ACCESSED : JUN 30, 2022.
US CDC. ELIZABETHKINGIA. ACCESSED : JUN 30, 2022.
US CDC. EMERGENCY DRINKING WATER. ACCESSED : JUN 30, 2022.
US CDC. EMERGENCY MEDICAL SERVICES WORKERS. ACCESSED : JUN 29, 2022.
US CDC. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : JUN 30, 2022.
US CDC. EMOTIONAL WELL-BEING. POPULATION HEALTH. ACCESSED : JUN 30, 2022.
US CDC. ENTAMOEBA GINGIVALIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. ENTEROBIASIS. DPDX. ACCESSED : MAY 3, 2022.
US CDC. ENTEROVIRUS A71. ACCESSED : JUN 30, 2022.
US CDC. ENTERVIRUS D68. ACCESSED : JUN 30, 2022.
US CDC. EPIDEMIOLOGY AND PREVENTION OF VACCINE-PREVENTABLE DISASES. THE PINK BOOK : COURSE TEXTBOOK. 14TH EDITION (2021). ACCESSED : JUN 30, 2022.
US CDC. EPILEPSY. ACCESSED : JUN 30, 2022.
US CDC. EPSTEIN-BARR VIRUS AND INFECTIOUS MONONUCLEOSIS. ACCESSED : JUN 30, 2022.
US CDC. ERGONOMICS AND MUSCULOSKELETAL DISORDERS. ACCESSED : JUN 25, 2022.
US CDC. ESTIMATES OF FOODBORNE ILLNESS IN THE UNITED STATES. ACCESSED : JUN 26, 2022.
US CDC. ETHYLENE GLYCOL. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. EXTREME HEAT. ACCESSED : JUN 30, 2022.
US CDC. FACTS ABOUT ANENCEPHALY. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT ANOPHTHALMIA AND MICROPHTHALMIA. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT ANOTIA AND MICROTIA. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT ATRIAL SEPTAL DEFECT. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT ATRIOVENTRICULAR SEPTAL DEFECT (AVSD). ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT CLEFT LIP AND CLEFT PALATE. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT COARCTATION OF THE AORTA. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT CRANIOSYNOSTOSIS. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT DEXTRO-TRANSPOSITION OF THE GREAT ARTERIES (D-TGA). ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT DIAPHRAGMATIC HERNIA. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT DOWN SYNDROME. ACCESSED : JUN 29, 2022.
US CDC. FACTS ABOUT ENCEPHALOCELE. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT ESOPHAGEAL ATRESIA. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT GASTROSCHISIS. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT HEREDITARY HEMORRHAGIC TELANGIECTASIA (HHT). ACCESSED : JUN 26, 2022.
US CDC. FACTS ABOUT HYPOPLASTIC LEFT HEART SYNDROME. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT HYPOSPADIAS. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT MICROCEPHALY. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT NEURAL TUBE DEFECTS. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT OMPHALOCELE. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT PULMONARY ATRESIA. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT TETRALOGY OF FALLOT. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT TOTAL ANOMALOUS PULMONARY VENOUS RETURN OR TAPVR. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT TRICUSPID ATRESIA. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT TRUNCUS ARTERIOSUS. ACCESSED : APR 16, 2022.
US CDC. FACTS ABOUT UPPER AND LOWER LIMB REDUCTION DEFECTS. ACCESSED : APR 16, 2022.|
US CDC. FACTS ABOUT VENTRICULAR SEPTAL DEFECT. ACCESSED : APR 16, 2022.
US CDC. FALLS IN THE WORKPLACE. ACCESSED : JUN 29, 2022.
US CDC. FARM ANIMALS. ACCESSED : MAY 1, 2022.
US CDC. FASCIOLIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. FASCIOLOPSIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. FERRETS. ACCESSED : MAY 1, 2022.
US CDC. FETAL ALCOHOL SPECTRUM DISORDERS (FASDS). ACCESSED : APR 30, 2022.
US CDC. FIBROMYALGIA. ACCESSED : APR 26, 2022.
US CDC. FILOVIRUSES (FILOVIRIDAE). ACCESSED : JUL 1, 2022.
US CDC. FIREARM VIOLENCE PREVENTION. ACCESSED : JUL 1, 2022.
US CDC. FISH. ACCESSED : MAY 1, 2022.
US CDC. FLAVIVIRIDAE. ACCESSED : JUL 1, 2022.
US CDC. FLEAS. ACCESSED : JUL 1, 2022.
US CDC. FLEAS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. FLOODS. ACCESSED : JUN 30, 2022.
US CDC. FOOD ALLERGIES. ACCESSED : APR 26, 2022.
US CDC. FREE LIVING AMEBIC INFECTIONS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. FUNGAL EYE INFECTIONS. ACCESSED : MAY 2, 2022.
US CDC. FUNGAL NAIL INFECTIONS. ACCESSED : MAY 2, 2022.
US CDC. GIARDIA. ACCESSED : MAY 2, 2022.
US CDC. GIARDIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. GLANDERS. ACCESSED : JUN 26, 2022.
US CDC. GLOBAL HEALTH - BANGLADESH. ACCESSED : JUN 25, 2022.
US CDC. GLOBAL HEALTH - BENIN. ACCESSED : JUN 25, 2022.
US CDC. GLOBAL HEALTH - BURKINA FASO. ACCESSED : JUN 26, 2022.
US CDC. GLOBAL HEALTH - CAMBODIA. ACCESSED : JUN 26, 2022.
US CDC. GLOBAL HEALTH - CAMEROON. ACCESSED : JUN 26, 2022.
US CDC. GLOBAL HEALTH - CENTRAL AMERICA. ACCESSED : JUN 30, 2022.
US CDC. GLOBAL HEALTH - CHINA. CDC IN CHINA. ACCESSED : JUN 28, 2022.
US CDC. GLOBAL HEALTH - DEMOCRATIC REPUBLIC OF CONGO. ACCESSED : JUN 29, 2022.
US CDC. GLOBAL HEALTH - DOMINICAN REPUBLIC. ACCESSED : JUN 29, 2022.
US CDC. GLOBAL HEALTH - ESWATINI. ACCESSED : JUN 30, 2022.
US CDC. GLOBAL HEALTH - ETHIOPIA. ACCESSED : JUN 30, 2022.
US CDC. GLUTARALDEHYDE. ACCESSED : MAY 5, 2022.
US CDC. GNATHOSTOMIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. GONGYLONEMA INFECTION. DPDX. ACCESSED : MAY 4, 2022.
US CDC. GOUT. ACCESSED : APR 26, 2022.
US CDC. GYNECOLOGIC CANCERS. ACCESSED : JUN 26, 2022.
US CDC. HAEMOPHILUS INFLUENZAE TYPE B (HIB) VIS. ACCESSED : APR 28, 2022.
US CDC. HANTAVIRUS. ACCESSED : MAY 2, 2022.
US CDC. HARMFUL ALGAL BLOOM (HAB)-ASSOCIATED ILLNESS. ACCESSED : JUN 29, 2022.
US CDC. HEALTH EQUITY. ACCESSED : JUN 30, 2022.
US CDC. HEALTHCARE-ASSOCIATED INFECTIONS (HAIS). BURKHOLDERIA CEPACIA. ACCESSED : JUN 25, 2022.
US CDC. HEALTHCARE-ASSOCIATED INFECTIONS. CLOSTRIDIOIDES DIFFICILE INFECTION. ACCESSED : JUN 26, 2022.
US CDC. HEALTHCARE-ASSOCIATED INFFECTIONS. CARBAPENEM-RESISTANT ENTEROBACTERALES (CRE). ACCESSED : JUN 26, 2022.
US CDC. HEALTHY BRAIN INITIATIVE. ACCESSED : JUN 29, 2022.
US CDC. HEALTHY CONTACT LENS WEAR AND CARE. ACCESSED : JUN 29, 2022.
US CDC. HEALTHY WEIGHT. ACCESSED : APR 26, 2022.
US CDC. HEARING LOSS IN CHILDREN. ACCESSED : JUN 29, 2022.
US CDC. HEART DISEASE. ACCESSED : JUN 27, 2022.
US CDC. HEMOPHILIA. ACCESSED : JUN 26, 2022.
US CDC. HEPATIC CAPILLARIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. HEPATITIS A ACIP VACCINE RECOMMENDATIONS. APR 27, 2022.
US CDC. HEPATITIS A VACCINATION. ACCESSED : APR 28, 2022.
US CDC. HEPATITIS A VIS. ACCESSED : APR 28, 2022.
US CDC. HEPATITIS B ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. HEPATITIS B VACCINATION. ACCESSED : APR 28, 2022.
US CDC. HEPATITIS B VIS. ACCESSED : APR 28, 2022.
US CDC. HEREDITARY BREAST AND OVARIAN CANCER. ACCESSED : JUN 26, 2022.
US CDC. HEREDITARY COLORECTAL (COLON) CANCER. ACCESSED : JUN 29, 2022.
US CDC. HETEROPHYIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. HIB (HAEMOPHILUS INFLUENZAE TYPE B) VACCINATION. ACCESSED : APR 28, 2022.
US CDC. HIB ACIP VACCINE RECOMMENDATIONS (HAEMOPHILUS INFLUENZAE TYPE B). ACCESSED : APR 28, 2022.
US CDC. HIGH BLOOD PRESSURE. ACCESSED : JUN 26, 2022.
US CDC. HISTOPLASMOSIS. ACCESSED : MAY 2, 2022.
US CDC. HIV. ACCESSED : APR 26, 2022.
US CDC. HOOKWORM (EXTRAINTESTINAL). DPDX. ACCESSED : MAY 2, 2022.
US CDC. HOOKWORM (INTESTINAL). DPDX. ACCESSED : MAY 2, 2022.
US CDC. HOOKWORM. ACCESSED : MAY 1, 2022.
US CDC. HORSES. ACCESSED : MAY 1, 2022.
US CDC. HPV (HUMAN PAPILLOMAVIRUS) VIS. ACCESSED : APR 28, 2022.
US CDC. HUMAN PAPILLOMAVIRUS (HPV) ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. HUMAN PAPILLOMAVIRUS (HPV) VACCINATION AND CANCER PREVENTION. ACCESSED : APR 28, 2022.
US CDC. HURRICANES AND OTHER TROPICAL STORMS. ACCESSED : JUN 30, 2022.
US CDC. HYDRAZINE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. HYDROFLUORIC ACID. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. HYDROGEN CHLORIDE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. HYMENOLEPIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. IMPAIRED DRIVING. ACCESSED : APR 30, 2022.
US CDC. IMPETIGO : ALL YOU NEED TO KNOW. ACCESSED : JUN 30, 2022.
US CDC. IMPORTATION. MAY 5, 2022.
US CDC. INACTIVATED INFLUENZA VIS. ACCESSED : APR 28, 2022.
US CDC. INCAPACITATING AGENTS. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. INDOOR FIRING RANGES. ACCESSED : JUL 1, 2022.
US CDC. INERIMCAPSIFER INFECTION. DPDX. ACCESSED : MAY 4, 2022.
US CDC. INFANT FORMULA FEEDING. ACCESSED : JUN 5, 2022.
US CDC. INFLAMMATORY BOWEL DISEASE (IBD). ACCESSED : JUN 29, 2022.
US CDC. INFLUENZA (FLU). ACCESSED : JUL 1, 2022.
US CDC. INFLUENZA ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. INFLUENZA(FLU) - ASTHMA. ACCESSED : JUN 25, 2022.
US CDC. INFORMATION FOR FAMILIES DURING THE INFANT FORMULA SHORTAGE. ACCESSED : JUN 5, 2022.
US CDC. INFORMATION FOR PARENTS WITH CHILDREN (APPROXIMATE AGES 4-11). ACCESSED : JUN 28, 2022.
US CDC. INFORMATION ON BIRD FLU. ACCESSED : MAY 1, 2022.
US CDC. INFORMATION ON SWINE / VARIANT INFLUENZA. ACCESSED : MAY 2, 2022.
US CDC. INJURIES AMONG CHILDREN AND TEENS. ACCESSED : JUN 28, 2022.
US CDC. INTESTINAL (NON-PATHOGENIC) AMEBAE. DPDX. ACCESSED : MAY 3, 2022.
US CDC. INTESTINAL CAPILLARIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. INTIMATE PARTNER VIOLENCE. ACCESSED : JUN 29, 2022.
US CDC. JAPANESE ENCEPHALITIS [VACCINATION]. ACCESSED : APR 28, 2022.
US CDC. JAPANESE ENCEPHALITIS ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. JAPANESE ENCEPHALITIS VIS. ACCESSED : APR 28, 2022.
US CDC. KLEBSIELLA PNEUMONIAE IN HEALTHCARE SETTINGS. ACCESSED : JUN 26, 2022.
US CDC. LANDSLIDES AND MUDSLIDES. ACCESSED : JUN 30, 2022.
US CDC. LEISHMANIASIS. ACCESSED : MAY 2, 2022.
US CDC. LEISHMANIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. LEPTOSPIROSIS. ACCESSED : MAY 2, 2022.
US CDC. LESBIAN, GAY, BISEXUAL, AND TRANSGENDER HEALTH. ACCESSED : JUN 26, 2022.
US CDC. LEWISITE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. LIFE EXPECTANCY. ACCESSED : JUN 30, 2022.
US CDC. LIGHTNING. ACCESSED : JUN 30, 2022.
US CDC. LIVE, INTRANASAL INFLUENZA VIS. ACCESSED : APR 28, 2022.
US CDC. LOIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. LOUSE-BORNE RELAPSING FEVER (LBRF). ACCESSED : JUN 26, 2022.
US CDC. LUNG CANCER. ACCESSED : JUN 26, 2022.
US CDC. LYME DISEASE. ACCESSED : MAY 1, 2022.
US CDC. LYMPHATIC FILARIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. LYMPHOCYTIC CHORIOMENINGITIS (LCM). ACCESSED : MAY 2, 2022.
US CDC. MALARIA. DPDX. ACCESSED : MAY 4, 2022.
US CDC. MANSONELLOSIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. MARIJUANA AND PUBLIC HEALTH. ACCESSED : JUN 26, 2022.
US CDC. MEASLES VACCINATION. ACCESSED : APR 28, 2022.
US CDC. MEDICATION SAFETY PROGRAM. ACCESSED : APR 29, 2022.
US CDC. MELIOIDOSIS. ACCESSED : JUN 26, 2022.
US CDC. MENINGITIS. ACCESSED : JUN 25, 2022.
US CDC. MENINGOCOCCAL ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. MENINGOCOCCAL ACWY VIS. ACCESSED : APR 28, 2022.
US CDC. MENINGOCOCCAL B VIS. ACCESSED : APR 28, 2022.
US CDC. MENINGOCOCCAL DISEASE. ACCESSED : JUN 25, 2022.
US CDC. MENINGOCOCCAL VACCINATION. ACCESSED : ARP 28, 2022.
US CDC. MERCURY. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. MESOCESTOIDIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. METAGONIMIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREAS (MRSA). ACCESSED : MAY 2, 2022.
US CDC. METHYL BROMIDE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. METHYL ISOCYANATE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. MICROSPORIDIOSIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. MMR (MEASLES, MUMPS, AND RUBELLA) VIS. ACCESSED : APR 28, 2022.
US CDC. MMR ACIP VACCINE RECOMMENDATIONS (MEASLES, MUMPS, AND RUBELLA)
US CDC. MMRV (MEASLES, MUMPS, RUBELLA AND VARICELLA) VIS. ACCESSED : APR 28, 2022.
US CDC. MMRV ACIP VACCINE RECOMMENDATIONS (MEASLES, MUMPS, RUBELLA, AND VARICELLA)
US CDC. MOLD. ACCESSED : JUN 29, 2022.
US CDC. MOLLUSCUM CONTAGIOSUM. ACCESSED : MAY 24, 2022.
US CDC. MONKEYPOX. ACCESSED : MAY 2, 2022.
US CDC. MOTORCYCLE SAFETY. ACCESSED : JUN 29, 2022.
US CDC. MUCORMYCOSIS. ACCESSED : MAY 2, 2022.
US CDC. MUMPS VACCINATION. ACCESSED : APR 28, 2022.
US CDC. MUSCULAR DYSTROPHY. ACCESSED : APR 16, 2022.
US CDC. MYALGIC ENCEPHALOMYELITIS / CHRONIC FATIGUE SYNDROME. ACCESSED : JUN 28, 2022.
US CDC. MYCETOMA. ACCESSED : MAY 2, 2022.
US CDC. MYIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. NAEGLERIA FOWLERI - PRIMARY AMEBIC MENINGOENCCEPHALITIS (PAM) - AMEBIC ENCEPHALITIS. ACCESSED : MAY 2, 2022.
US CDC. NATIONAL AMYOTROPHIC LATERAL SCLEROSIS (ALS) REGISTRY. ACCESSED : MAY 1, 2022.
US CDC. NATIONAL BIOMONITORING PROGRAM. ACCESSED : JUN 26, 2022.
US CDC. NATIONAL COMPREHENSIVE CANCER CONTROL PROGRAM (NCCCP). ACCESSED : JUN 29, 2022.
US CDC. NATIONAL VOLUNTARY ACCREDITATION FOR PUBLIC HEALTH DEPARTMENTS. ACCESSED : APR 26, 2022.
US CDC. NECROTIZING FASCIITIS : ALL YOU NEED TO KNOW. ACCESSED : JUN 30, 2022.
US CDC. NERVE AGENTS. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. NICOTINE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. NITRIC ACID. ACCESSED : MAY 5, 2022.
US CDC. NITROGEN MUSTARD. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. NITROUS OXIDE. ACCESSED : MAY 5, 2022.
US CDC. NON-PATHOGENIC FLAGELLATES. DPDX. ACCESSED : MAY 4, 2022.
US CDC. NON-POLIO ENTEROVIRUS. ACCESSED : JUN 30, 2022.
US CDC. NURSING HOMES AND ASSISTED LIVING (LONG-TERM CARE FACILITIES). ACCESSED : JUN 25, 2022.
US CDC. NUTRITION. ACCESSED : JUN 29, 2022.
US CDC. OESOPHAGOSTOMIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. OLDER ADULT DRIVERS. ACCESSED : APR 30, 2022.
US CDC. OLDER ADULT FALL PREVENTION. ACCESSED : JUN 30, 2022.
US CDC. ONCHOCERCIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. OPIOIDS (FENTANYL, ETORPHINE, OR OTHERS). EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. OPISTHORCHIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. ORF VIRUS (SORE MOUTH INFECTION). ACCESSED : MAY 2, 2022.
US CDC. OROPOUCHE. ACCESSED : OCT 6, 2024.
US CDC. OSMIUM TETROXIDE. ACCESSED : MAY 5, 2022.
US CDC. OSMIUM TETROXIDE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. OSTEOARTHRITIS (OA). ACCESSED : APR 26, 2022.
US CDC. PARACOCCIDIOIDOMYCOSIS. ACCESSED : MAY 2, 2022.
US CDC. PARAGONIMIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. PARAQUAT. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. PARASITES - AFRICAN TRYPANOSOMIASIS (ALSO KNOWN AS SLEEPING SICKNESS). ACCESSED : APR 26, 2022.
US CDC. PARASITES - ASCARIASIS. ACCESSED : JUN 25, 2022.
US CDC. PARASITES - BABESIOSIS. ACCESSED : JUN 25, 2022.
US CDC. PARASITES - BALANTIDIASIS (ALSO KNOWN AS BALANTIDIUM COLI INFECTION). ACCESSED : JUN 25, 2022.
US CDC. PARASITES - BED BUGS. ACCESSED : JUN 25, 2022.
US CDC. PARASITES - BLASTOCYSTIS SPP. INFECTION. ACCESSED : JUN 26, 2022.
US CDC. PARASITES - CAPILLARIASIS (ALSO KNOWN AS CAPILLARIA INFECTION). ACCESSED : JUN 26, 2022.
US CDC. PARASITES - CERCARIAL DERMATITIS (ALSO KNOWN AS SWIMMER’S ITCH). ACCESSED : JUN 28, 2022.
US CDC. PARASITES - CLONORCHIS. ACCESSED : JUN 28, 2022.
US CDC. PARASITES - CYSTOISOSPORIASIS (FORMERLY KNOWN AS ISOSPORIASIS). ACCESSED : JUN 29, 2022.
US CDC. PARASITES - DIETAMOEBA FRAGILIS. ACCESSED : JUN 29, 2022.
US CDC. PARASITES - DIPHYLLOBOTHRIUM INFECTION. ACCESSED : JUN 29, 2022.
US CDC. PARASITES - DIROFILARIASIS. ACCESSED : JUN 29, 2022.
US CDC. PARASITES - ENTEROBIASIS (ALSO KNOWN AS PINWORM INFECTION). ACCESSED : JUN 30, 2022.
US CDC. PARASITES - FASCIOLIASIS. ACCESSED : JUN 30, 2022.
US CDC. PARASITES - FASCIOLOPSIASIS. ACCESSED : JUN 30, 2022.
US CDC. PARASITES - GUINEA WORM. ACCESSED : JUN 29, 2022.
US CDC. PARASITES - HYMENOLEPIASIS (ALSO KNOWN AS HYMENOLEPIS NANA INFECTION). ACCESSED : JUN 30, 2022.
US CDC. PARASITES - LYMPHATIC FILARIASIS. ACCESSED : JUN 30, 2022.
US CDC. PARASITES - SCHISTOSOMIASIS. ACCESSED : JUN 26, 2022.
US CDC. PARASITES. BODY LICE. ACCESSED : JUN 26, 2022.
US CDC. PARSITES - CYCLOSPORIASIS (CYCLOSPORA INFECTION). ACCESSED : JUN 29, 2022.
US CDC. PARVOVIRUS B19 AND FIFTH DISEASE. ACCESSED : OCT 6, 2024.
US CDC. PEDESTRIAN SAFETY. ACCESSED : JUN 29, 2022.
US CDC. PEDICULOSIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. PERSONS WHO INJECT DRUGS (PWID). US CDC. DRINKING WATER. ACCESSED : JUN 30, 2022.
US CDC. PHILOPHTHALMIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. PHOSGENE OXIME. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. PHOSGENE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. PHOSPHINE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. PHOSPHORUS, ELEMENTAL, WHITE OR YELLOW. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. PHYSICAL ACTIVITY. ACCESSED : JUN 30, 2022.
US CDC. PLAGUE. ACCESSED : MAR 1, 2022.
US CDC. PNEUMOCOCCAL ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 27, 2022.
US CDC. PNEUMOCOCCAL CONJUGATE VIS. ACCESSED : APR 28, 2022.
US CDC. PNEUMOCOCCAL POLYSACCHARIDE VIS. ACCESSED : APR 28, 2022.
US CDC. PNEUMOCOCCAL VACCINATION. APR 28, 2022.
US CDC. PNEUMOCYSTIS PNEUMONIA. ACCESSED : MAY 2, 2022.
US CDC. PNEUMOCYSTIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. POLIO ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 28, 2022.
US CDC. POLIO VACCINATION. ACCESSED : APR 28, 2022.
US CDC. POLIO VIS. ACCESSED : APR 28, 2022.
US CDC. POST-STREPTOCOCCAL GLOMERULONEPHRITIS : ALL YOU NEED TO KNOW. ACCESSED : JUN 30, 2022.
US CDC. PREVENT ILLNESS FROM C. PERFRINGENS. ACCESSED : JUN 29, 2022.
US CDC. PRION DISEASES. ACCESSED : MAY 1, 2022.
US CDC. PROSTATE CANCER. ACCESSED : JUN 26, 2022.
US CDC. PSITTACOSIS. ACCESSED : MAY 2, 2022.
US CDC. PTHIRIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. PUBLIC HEALTH DATA INTEROPERABILITY. ACCESSED : JUN 30, 2022.
US CDC. PUBLIC HEALTH ETHICS. ACCESSED : JUN 30, 2022.
US CDC. Q FEVER. ACCESSED : MAY 2, 2022.
US CDC. RABIES VACCINATION. ACCESSED : APR 28, 2022.
US CDC. RABIES VIS. ACCESSED : APR 28, 2022.
US CDC. RABIES. ACCESSED : MAY 2, 2022.
US CDC. RAILLIETINA INFECTION. DPDX. ACCESSED : MAY 4, 2022.
US CDC. RATE-BITE FEVER (RBF). ACCESSED : MAY 2, 2022.
US CDC. RECOMBINANT SHINGLES VIS. ACCESSED : APR 28, 2022.
US CDC. REPRODUCTIVE HEALTH : TEEN PREGNANCY. ACCESSED : APR 26, 2022.
US CDC. REPTILES AND AMPHIBIANS. ACCESSED : MAY 1, 2022.
US CDC. RESPIRATORY SYNCYTIAL VIRUS INFECTION (RSV). ACCESSED : JUN 26, 2022.
US CDC. RHEUMATIC FEVER : ALL YOU NEED TO KNOW. ACCESSED : JUN 30, 2022.
US CDC. RHEUMATOID ARTHRITIS (RA). ACCESSED : APR 26, 2022.
US CDC. RICIN. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. RIFT VALLEY FEVER (RVF). ACCESSED : MAY 2, 2022.
US CDC. RINGWORM. ACCESSED : MAY 2, 2022.
US CDC. RIOT CONTROL AGENTS. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. ROCKY MOUNTAIN SPOTTED FEVER (RMSF). ACCESSED : MAY 2, 2022.
US CDC. ROTAVIRUS ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 28, 2022.
US CDC. ROTAVIRUS VACCINATION. ACCESSED : APR 28, 2022.
US CDC. ROTAVIRUS VIS. ACCESSED : APR 28, 2022.
US CDC. RUBELLA (GERMAN MEASLES) VACCINATION. ACCESSED : APR 28, 2022.
US CDC. SALMONELLA INFECTION. ACCESSED : MAY 2, 2022.
US CDC. SAPPINIA - AMEBIC ENCEPHALITIS. ACCESSED : MAY 2, 2022.
US CDC. SARCOCYSTOSIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. SARIN (GB). EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SAXITOXIN. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SCABIES. ACCESSED : MAY 2, 2022.
US CDC. SCARLET FEVER : ALL YOU NEED TO KNOW. ACCESSED : JUN 30, 2022.
US CDC. SCHISTOSOMIASIS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. SEASONAL INFLUENZA (FLU) VACCINATION AND PREVENTABLE DISEASE. ACCESSED : APR 28, 2022.
US CDC. SEAT BELTS. ACCESSED : JUN 29, 2022.
US CDC. SECONDHAND SMOKE. ACCESSED : MAY 10, 2022.
US CDC. SELENIUM. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SHINGLES (HERPES ZOSTER) VACCINATION. APR 28, 2022.
US CDC. SICKLE CELL DISEASE (SCD). ACCESSED : JUN 26, 2022.
US CDC. SKIN CANCER. ACCESSED : JUN 26, 2022.
US CDC. SMALL MAMMAL-ASSOCIATED INFECTIONS. ACCESSED : MAY 1, 2022.
US CDC. SMALLPOX ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 28, 2022.
US CDC. SMALLPOX VACCINATION. ACCESSED : APR 28, 2022.
US CDC. SODIUM AZIDE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SODIUM MONOFLUOROACETATE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SOMAN (GD). EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SPARGANOSIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. SPINA BIFIDA. ACCESSED : APR 16, 2022.
US CDC. SPOROTRICHOSIS. ACCESSED : MAY 2, 2022.
US CDC. STILLBIRTH. ACCESSED : JUL 1, 2022.
US CDC. STREP THROAT : ALL YOU NEED TO KNOW. ACCESSED : JUN 30, 2022.
US CDC. STREPTOCOCCAL TOXIC SHOCK SYNDROME : ALL YOU NEED TO KNOW. ACCESSED : JUN 30, 2022.
US CDC. STRONGYLOIDIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. STRYCHNINE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SULFUR MUSTARD (MUSTARD GAS). EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SULFURYL FLUORIDE. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. SUPER WARFARIN. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. TABUN (GA). EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. TAENIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. TALAROMYCOSIS (FORMERLY PENICILLIOSIS). ACCESSED : MAY 2, 2022.
US CDC. TD (TETANUS, DIPHTHERIA) VIS. ACCESSED : APR 28, 2022.
US CDC. TEEN DRIVERS. ACCESSED : JUN 29, 2022.
US CDC. TETANUS VACCINATION. ACCESSED : APR 28, 2022.
US CDC. TETANUS. ACCESSED : JUN 29, 2022.
US CDC. TETRACHLOROETHYLENE PERCHLOROETHYLENE). ACCESSED : MAY 5, 2022.
US CDC. TETRODOTOXIN. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. THALASSEMIA. ACCESSED : JUN 26, 2022.
US CDC. THALLIUM. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. THELAZIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. THERE ARE VACCINES YOU NEED AS AN ADULT. ACCESSED : APR 29, 2022.
US CDC. THIMEROSAL. ACCESSED : JUN 25, 2022.
US CDC. TICKS. ACCESSED : MAY 2, 2022.
US CDC. TICKS. DPDX. ACCESSED : MAY 2, 2022.
US CDC. TORNADOES. ACCESSED : JUN 30, 2022.
US CDC. TOXIC ALCOHOLS. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. TOXOCARIASIS (ALSO KNOWN AS ROUNDWORM INFECTION). ACCESSED : MAY 2, 2022.
US CDC. TOXOCARIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. TOXOPLASMOSIS (TOXOPLASMA INFECTION). ACCESSED : MAY 2, 2022.
US CDC. TOXOPLASMOSIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. TRAUMATIC BRAIN INJURY & CONCUSSION. ACCESSED : JUN 28, 2022.
US CDC. TRAVEL TO MASS GATHERINGS. ACCESSED : OCT 31, 2022.
US CDC. TRICHINELLOSIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. TRICHOMONIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. TRICHOSTRONGYLOSIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. TRICHOTHECENE MYCOTOXIN. EMERGENCY PREPAREDNESS AND RESPONSE. ACCESSED : MAY 5, 2022.
US CDC. TRICHURIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. TRYPANOSOMIASIS, AFRICAN. DPDX. ACCESSED : MAY 2, 2022.
US CDC. TSUNAMIS. ACCESSED : JUN 30, 2022.
US CDC. TUBERCULOSIS (TB) VACCINATION. ACCESSED : APR 28, 2022.
US CDC. TUBERCULOSIS (TB). ACCESSED : JUN 30, 2022.
US CDC. TULAREMIA. ACCESSED : MAY 2, 2022.
US CDC. TUNGIASIS. DPDX. ACCESSED : MAY 4, 2022.
US CDC. TYPHOID ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 28, 2022.
US CDC. TYPHOID FEVER VACCINATION. ACCESSED : APR 28, 2022.
US CDC. TYPHOID VIS. ACCESSED : APR 29, 2022.
US CDC. TYPHUS FEVERS. ACCESSED : JUN 30, 2022.
US CDC. UNDERAGE DRINKING. ACCESSED : APR 30, 2022.
US CDC. VACCINE ADVERSE EVENT REPORTING SYSTEM (VAERS). ACCESSED : APR 29, 2022.
US CDC. VACCINE INFORMATION STATEMENTS (VISS). ACCESSED : APR 28, 2022.
US CDC. VACCINE SAFETY. ACCESSED : JUN 30, 2022.
US CDC. VALLEY FEVER (COCCIDIOIDOMYCOSIS). ACCESSED : JUN 29, 2022.
US CDC. VARIANT CREUTZFELDT-JAKOB DISEASE (VCJD). ACCESSED : MAY 1, 2022.
US CDC. VARICELLA ACIP VACCINE RECOMMENDATIONS. ACCESSED : APR 28, 2022.
US CDC. VENOUS THROMBOEMBOLISM (BLOOD CLOTS). ACCESSED : JUN 26, 2022.
US CDC. VESSEL SANITATION PROGRAM (VSP). ACCESSED : JUN 29, 2022.
US CDC. VIOLENCE PREVENTION. ACCESSED : JUN 29, 2022.
US CDC. VIRAL HEMORRHAGIC FEVERS (VHFS). ACCESSED : JUL 1, 2022.
US CDC. VIRAL MENINGITIS. ACCESSED : JUN 25, 2022.
US CDC. VISION HEALTH INITIATIVE (VHI). ACCESSED : JUN 30, 2022.
US CDC. VITAMIN K DEFICIENCY BLEEDING. ACCESSED : JUN 26, 2022.
US CDC. VOLCANOES. ACCESSED : JUN 30, 2022.
US CDC. VON WILLEBRAND DISEASE (VWD). ACCESSED : JUN 26, 2022.
US CDC. WATER, SANITIATION, AND HYGIENE (WASH) - RELATED EMERGENCIES AND OUTBREAKS. ACCESSED : JUN 30, 2022.
US CDC. WEST NILE VIRUS. ACCESSED : JUN 29, 2022.
US CDC. WHAT IS A MAMMOGRAM? ACCESSED : JUN 26, 2022.
US CDC. WHOOPING COUGH (PERTUSSIS) VACCINATION. ACCESSED : APR 28, 2022.
US CDC. WILDFIRES. ACCESSED : JUN 30, 2022.
US CDC. WILDLIFE-ASSOCIATED INFECTIONS. ACCESSED : MAY 1, 2022.
US CDC. WINTER WEATHER. ACCESSED : JUN 30, 2022.
US CDC. WORK AND FATIGUE. ACCESSED : JUL 1, 2022.
US CDC. YELLOW FEVER ACIP VACCINE RECOMMENDATIONS. APR 28, 2022.
US CDC. YELLOW FEVER VACCINATION. ACCESSED : APR 28, 2022.
US CDC. YELLOW FEVER VIS. ACCESSED : APR 29, 2022.
US CDC. YERSINIA ENTEROCOLITICA (YERSINIOSIS). ACCESSED : MAY 2, 2022.
US CDC. YOUR CHILD’S FIRST VACCINES. ACCESSED : APR 28, 2022.
US CDC. ZOONOTIC HOOKWORM. ACCESSED : MAY 1, 2022.
US CDC. ZOSTER (SHINGLES) ACIP VACCINE RECOMMENDATIONS. APR 28, 2022.
US DHHS. OASH. BLADDER PAIN. ACCESSED : FEB 12, 2022.
US DOJ. ADA.GOV. ACCESSED : JAN 26, 2023.
US EPA. CARBON MONOXIDE (CO) POLLUTION IN OUTDOOR AIR. ACCESSED : APR 29, 2022.
US EPA. GROUND-LEVEL OZONE POLLUTION. ACCESSED : APR 29, 2022.
US EPA. LEAD (PB) AIR POLLUTION. ACCESSED : APR 29, 2022.
US EPA. NITROGEN DIOXIDE (NOS2) POLLUTION. ACCESSED : APR 29, 2022.
US EPA. PARTICULATE MATTER (PM) POLLUTION. ACCESSED : APR 29, 2022.
US EPA. SULFUR DIOXIDE (SO2) POLLUTION. ACCESSED : APR 29, 2022.
US FA. GUIDANCE. REDBOOK 2000 : IV.B.4. STATISTICAL CONSIDERATIONS IN TOXICITY STUDIES. JUN 2007.
US FD.A GUIDANCE FDA DECISIONS FOR INVESTIGATIONAL DEVICE EXEMPTION CLINICAL INVESTIGATIONS. AUG 19, 2014.
US FDA. 510(K) CHECKLIST FOR MECHANICAL LITHOTRIPTERS AND STONE DISLODGERS USED IN GASTROENTEROLOGY AND UROLOGY. NOV 1, 1994.
US FDA. 510(K) CLEARANCES. ACCESSED : MAR 23, 2022.
US FDA. 522 POSTMARKET SURVEILLANCE STUDIES PROGRAM. ACCESSED : MAR 23, 2022.
US FDA. ABOUT MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE). ACCESSED : MAR 23, 2022.
US FDA. ACAM 2000. ACCESSED : MAY 24, 2022.
US FDA. ACCELERATED APPROVAL PROGRAM. ACCESSED : MAR 23, 2022.
US FDA. ACCELERATING ACCESS TO CCRITICAL THERAPIES FOR ALS ACT - ACT FOR ALS. SEP 1, 2022.
US FDA. ACCESS TO PRODUCT SAMPLES : THE CREATES ACT. ACCESSED SEP 21, 2022.
US FDA. ACROMEGALY : DEVELOPING DRUGS FOR TREATMENT. JAN 2023.
US FDA. ANTIMICROBIAL ANIMAL DRUG SALES AND DISTRIBUTION REPORTING. SMALL ENTITY COMPLIANCE GUIDE. JUN 2018.
US FDA. BIOCOMPATIBILITY TESTING OF MEDICAL DEVICES - STANDARDS SPECIFIC INFORMATION FOR THE ACCREDITATION SCHEME FOR CONFORMITY ASSESSMENT (ASCA) PILOT PROGRAM. SEP 2020.
US FDA. BIOLOGIC LICENSE APPLICATIONS (BLA) PROCESS (CBER). ACCESSED : MAR 23, 2022.
US FDA. BIOLOGICS ESTABLISHMENT REGISTRATION. ACCESSED : MAR 23, 2022.
US FDA. CDER SMALL BUSINESS AND INDUSTRY ASSISTANCE (SBIA). ACCESSED : JUN 7, 2022.
US FDA. CDRH LEARN.
US FDA. CDRH TRANSPARENCY : TOTAL PRODUCT LIFE CYCLE (TPLC). ACCESSED : MAR 23, 2022.
US FDA. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH. ACCESSED : MAR 23, 2022.
US FDA. CERVARIX. ACCESSED : MAY 18, 2022.
US FDA. CLASSIFY YOUR MEDICAL DEVICE. ACCESSED : MAR 23, 2022.
US FDA. CLINICAL INVESTIGATOR INSPECTON LIST (CLIIL). ACCESSED : MAR 23, 2022.
US FDA. CLINICAL LABORATORY IMPROVEMENT AMENDMENTS (CLIA). ACCESSED : MAR 23, 2022.
US FDA. CODE OF FEDERAL REGULATIONS - TITLE 21 - FOOD AND DRUGS. ACCESSED : MAR 23, 2022.
US FDA. COMPILATION OF CDER NEW MOLECULAR ENTITY (NME) DRUG AND NEW BIOLOGIC APPROVALS - DATA DICTIONARY. ACCESSED : MAR 23, 2022.
US FDA. COMPLIANCE POLICY GUIDE. CPG 230.120- HUMAN BLOOD AND BLOOD PRODUCTS AS DRUGS. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG 515.700 CHOCOLATE & CHOCOLATE LIQUOR - ADULTERATION WITH INSECT AND RODENT FILTH. AUG 01, 2000.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 100.101 CROTALARIA SPP. SEEDS IN GRAINS. SEP 21, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 100.200 FDA JURISDICTION OVER PRODUCTS COMPOSED OF INTERSTATE INGREDIENTS. AUG 31, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 100.600 STATUS OF FACIAL TISSUES, PAPER NAPKINS, PAPER TOWELS AND SIMILAR PAPER PRODUCTS. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 100.900INTERNATIONAL MEMORANDA OF UNDERSTANDING. JUN 06, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 110.310 PRIOR NOTICE OF IMPORTED FOOD UNDER THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002. MAY 2009.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 110.900 IMPORTED PRODUCTS - LACK OF ENGLISH LABELING. AUG 20, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 120.500 HEALTH FRAUD - FACTORS IN CONSIDERING REGULATORY ACTION. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 430.100 UNIT DOSE LABELING FOR SOLID AND LIQUID ORAL DOSAGE FORMS. JAN 31, 1984.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 500.100 ADDITIVES - LABELING WITH ADEQUATE DIRECTIONS FOR MANY USES. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 500.200 FOOD ADDITIVES -"GRAS". NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 500.250 FOOD ADDITIVES - LABELING DIRECTIONS NECESSARY FOR SAFE USE: CPG SEC 500.250 FOOD ADDITIVES. AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 500.300 "APPROVED BY FDA" - USE OF PHRASE OBJECTIONABLE IN MARKETING OR LABELING OF A FOOD ADDITIVE. AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 500.400 USE OF CALCIUM CHLORIDE AS A DRYING AGENT IN SUCH PRODUCTS AS PACKAGED POTATO CHIPS AND PEANUTS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 500.425 USE OF COLOR ADDITIVES IN PAPER AND PAPERBOARD INTENDED FOR USE WITH FOOD. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 500.450 VOLATILE N-NITROSAMINES IN RUBBER BABY BOTTLE NIPPLES. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 505.100 BAKERY PRODUCTS, CANDY - "CATCH-ALL" OR "SHOTGUN" INGREDIENTS DECLARATION. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 505.200 "BUTTER" FEATURED IN PRODUCT NAME. MAR 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 505.300 "BUTTER-NUT" BREAD. MAR 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 505.350 HONEY BREAD, HONEY BUNS. MAR 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 505.400 CHOW MEIN NOODLES, CHINESE NOODLES AND OTHER ORIENTAL NOODLES (LABELING). AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 505.500 MACARONI AND NOODLE PRODUCTS - ADULTERATION INVOLVING INSECT FRAGMENTS AND RODENT HAIRS. AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.100 BEVERAGE BASES. NOV 01, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.150 APPLE JUICE, APPLE JUICE CONCENTRATES, AND APPLE JUICE PRODUCTS - ADULTERATION WITH PATULIN. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.200 BRANDY CONTAINING METHYL ALCOHOL - FOOD ADDITIVE. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.300 UNFERMENTED BEVERAGES - USE OF WORD "CHAMPAGNE". OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.400 DEALCOHOLIZED WINE AND MALT BEVERAGES - LABELING. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.450 LABELING - DILUTED WINES AND CIDER WITH LESS THAN 7% ALCOHOL. AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.500 GREEN COFFEE BEANS - ADULTERATION WITH INSECTS, MOLD. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.600 DIMETHYLNITROSAMINE IN MALT BEVERAGES. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 510.700 FORTIFICATION OF STANDARDIZED JUICES. AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.100 CONFECTIONERY - USE OF NON-NUTRITIVE SUBSTANCES AS INGREDIENTS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.200 MALT EXTRACT, MALT SYRUP, MALTED CEREAL SYRUP, LIQUID MALT, DRIED MALT. AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.300 HONEY - SOURCE DECLARATION. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.350 CANDY - MIXED WITH TRINKETS AND SOLD IN VENDING MACHINES. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.400 RAW SUGAR. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.425 SUGAR - WATER DAMAGED - RECONDITIONING. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.500 BARLEY SUGAR - DEFINITION, AND BARLEY SUGAR CANDY. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.600 CANDIED CITRON - LABELING. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.750 COCOA BEANS - ADULTERATION BY MOLD, INSECT INFESTATION, AND MAMMALIAN EXCRETA. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.775 COCOA POWDER, PRESS CAKE - ADULTERATION WITH INSECT AND RODENT FILTH. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 515.800 LABELING OF PRODUCTS PURPORTING TO BE "CHOCOLATE" OR "CHOCOLATE FLAVORED". MAY 12, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 520.100 CANNED FOODS, USE OF THE TERM "SOLID PACK". FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 520.200 CANNED FOODS - SEAM DEFECTS. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 520.300 ACIDIFIED LOW-ACID CANNED FOODS - ADULTERATION DUE TO HIGH PH. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.100 WHOLE & GROUND ALLSPICE - ADULTERATION BY MOLD, INSECT & RODENT FILTH. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.150 BAY (LAUREL) LEAVES - ADULTERATION BY INSECT FILTH, MOLD, MAMMALIAN EXCRETA. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.200 CAPSICUM PODS, GROUND CAPSICUMS EXCLUDING PAPRIKA, GROUND PAPRIKA - ADULTERATION WITH INSECT AND RODENT FILTH, MOLD, MAMMALIAN EXCRETA. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.225 - WHOLE CASSIA OR WHOLE CINNAMON, GROUND CINNAMON - ADULTERATION BY INSECT AND RODENT FILTH, MOLD, MAMAMMALIAN EXCRETA. MAY 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.250 CLOVES - ADULTERATION WITH STEMS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.300 CONDIMENTAL SEEDS OTHER THAN FENNEL SEEDS AND SESAME SEEDS - ADULTERATION BY MAMMALIAN EXCRETA. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.325 CUMIN SEED - ADULTERATION WITH SAND AND GRIT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.330 CURRY POWDER - ADULTERATION BY INSECT AND RODENT FILTH. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.350 FENNEL SEED - ADULTERATION BY MAMMALIAN EXCRETA, INSECTS. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.375 WHOLE GINGER - ADULTERATION WITH INSECT FILTH, MOLD, MAMMALIAN EXCRETA. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.400 HOLLANDAISE SAUCE - COMMON OR USUAL NAME. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.425 HOPS - ADULTERATION INVOLVING APHID INFESTATION. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.500 LEAFY SPICES, OTHER THAN BAY LEAVES - WHOLE OREGANO LEAVES, WHOLE MARJORAM, WHOLE SAGE LEAVES AND WHOLE THYME LEAVES - ADULTERATION WITH INSECT FILTH, MOLD, MAMMALIAN EXCRETA. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.550 MACE - ADULTERATION WITH INSECT FILTH, MOLD, FOREIGN MATTER, MAMMALIAN EXCRETA. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.575 PREPARED MUSTARD - COMPOSITION. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.600 WHOLE AND GROUND NUTMEG - ADULTERATION WITH INSECT FILTH, MOLD, RODENT FILTH. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.625 WHOLE AND GROUND PEPPER - ADULTERATION WITH INSECT & RODENT FILTH, MOLD, MAMMALIAN EXCRETA, FOREIGN MATTER. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.650 LABELING OF SEASONINGS. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.700 SESAME SEEDS - ADULTERATION WITH INSECT FILTH, DECOMPOSITION, MAMMALIAN EXCRETA FOREIGN MATTER. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.750 SPICES - DEFINITIONS. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.800 TOMATO SAUCE OR TOMATO HOT SAUCE LABELING. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.825 VINEGAR, DEFINITIONS - ADULTERATION WITH VINEGAR EELS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.850 WHOLE PLANT (UNPROCESSED) OREGANO, CRUSHED OREGANO & GROUND OREGANO - ADULTERATION BY INSECT & RODENT FILTH, MOLD, MAMMALIAN EXCRETA. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.900 WHOLE PLANT (UNPROCESSED) MARJORAM, UNGROUND (PROCESSED) MARJORAM & GROUND MARJORAM - ADULTERATION BY INSECT & RODENT FILTH, MOLD, MAMMALIAN EXCRETA. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.925 WHOLE PLANT (UNPROCESSED) THYME, UNGROUND (PROCESSED) THYME & GROUND THYME - ADULTERATION BY INSECT & RODENT FILTH, MOLD, MAMMALIAN EXCRETA. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 525.950 WHOLE PLANT (UNPROCESSED) SAGE, AND GROUND SAGE - ADULTERATION BY INSECT AND RODENT FILTH, MOLD, MAMMALIAN EXCRETA.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.100 BUTTER - ADULTERATION INVOLVING INSUFFICIENT FAT CONTENT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.200 CHEESE & CHEESE PRODUCTS - ADULTERATION WITH FILTH. AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.225 CHEESE - MISBRANDING DUE TO MOISTURE AND FAT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.250 CHEESE & CHEESE PRODUCTS - MISBRANDING INVOLVING NET CONTENTS. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.350 EGGNOG, EGG NOG FLAVORED MILK - COMMON OR USUAL NAMES. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.400 WHOLE MILK, LOWFAT MILK, SKIM MILK - AFLATOXIN M1. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.450 MILK & MILK PRODUCTS CONTAINING PENICILLIN. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.500 MALTED MILK. JUL 31, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 527.600 USE OF DDVP (DICHLORVOS) STRIPS IN MILKHOUSES AND MILKROOMS. JUL 31, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 530.500 WHEAT GERM CONTAINING NON-WHEAT GERM TISSUE. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 535.100 OLEOMARGARINE - MISBRANDING DUE TO INSUFFICIENT FAT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 537.100 EGGS AND EGG PRODUCTS - FROZEN - ADULTERATION INVOLVING DECOMPOSITION. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.150 CAVIAR, USE OF TERM - LABELING. OCT 29, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.200 CHUBS, HOT PROCESS SMOKED WITH ADDED NITRITE - ADULTERATION INVOLVING FOOD ADDITIVES, SODIUM NITRITE. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.250 CLAMS, MUSSELS, OYSTERS, FRESH, FROZEN OR CANNED - PARALYTIC SHELLFISH POISON. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.285 CRABMEAT PRODUCTS - LABELING. CRABMEAT PRODUCTS WITH ADDED FISH OR OTHER SEAFOOD INGREDIENTS - LABELING. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.410 SHRIMP - FROZEN, RAW, BREADED OR LIGHTLY BREADED, MISBRANDING INVOLVING NON-COMPLIANCE WITH STANDARDS. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.450 *IMITATION BREADED SHRIMP. OCT 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.500 TUNA, SABLE, SALMON, SHAD-SMOKED CURED, ADULTERATION INVOLVING FOOD ADDITIVES, SODIUM NITRITE. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.525 DECOMPOSITION AND HISTAMINE RAW, FROZEN TUNA AND MAHI-MAHI, CANNED TUNA, AND RELATED SPECIES. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.550 KIPPER AND KIPPER UNSPLIT - DEFINITIONS. OCT 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.590 FISH - FRESH AND FROZEN, AS LISTED - ADULTERATION BY PARASITES. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 540.650 UNEVISCERATED FISH PRODUCTS THAT ARE SALT-CURED, DRIED, OR SMOKED (REVISED). NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 545.200 CONFECTIONERY DECORATIONS (NUTRITIVE AND NON-NUTRITIVE). JUN 27, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 545.300 FOODS, RAIL CAR SANITATION - ADULTERATION. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 545.400 POTTERY (CERAMICS). IMPORT AND DOMESTIC - CADMIUM CONTAMINATION. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 545.450 POTTERY (CERAMICS). IMPORT AND DOMESTIC - LEAD CONTAMINATION. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 545.500 SILVER-PLATED HOLLOWWARE - LEAD CONTAMINATION. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 545.600 CINNAMON-FLAVORED TOOTHPICKS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.100 APPLE BUTTER - ADULTERATION WITH MOLD, RODENT FILTH, INSECT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.150 APRICOTS - CANNED - ADULTERATION WITH INSECTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.200 DRUPELET BERRIES (BLACKBERRIES, RASPBERRIES, ETC.) - COMMON OR USUAL NAMES OF VARIETIES. CANNED AND FROZEN - ADULTERATION WITH ROT AND INSECTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.225 CHERRIES BRINED, FRESH, CANNED AND FROZEN - ADULTERATION INVOLVING ROT AND INSECT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.230 CHERRIES, CANNED - MISBRANDING INVOLVING FOOD STANDARDS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.235 CHERRY JAM - ADULTERATION WITH MOLD. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.250 CITRUS FRUIT JUICES, CANNED - ADULTERATION WITH FLY FILTH AND MOLD. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.260 CRANBERRY SAUCE - ADULTERATION WITH MOLD. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.270 CURRANTS - ADULTERATION INVOLVING WORMY FRUITS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.300 DATES AND DATE MATERIAL, IMPORTED AND DOMESTIC - ADULTERATION INVOLVING MOLD, INSECT EXCRETA, SOUR, DIRTY, WORTHLESS AND PITS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.350 FIGS, FIG PASTE - ADULTERATION INVOLVING INSECT INFESTATION, MOLD, DIRT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.400 GRENADINE. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.450 JAM, BLACK CURRANT - ADULTERATION WITH MOLD. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.475 JELLIES, NONSTANDARDIZED. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.500 LINGON BERRIES, CANNED - ADULTERATION BY INSECTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.550 MARASCHINO CHERRIES. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.575 MARMALADE. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.590 CLOUDBERRIES (MULTER BERRIES), CANNED - ADULTERATION BY INSECTS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.600 OLIVES - ADULTERATION INVOLVING PITS, ROT, INSECT INFESTATION. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.605 OLIVES STUFFED WITH MINCED PIMENTOS - LABELING. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.625 ORANGES - ARTIFICIAL COLORING. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.650 PEACHES, CANNED, FROZEN - ADULTERATION DUE TO INSECTS AND MOLD. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.655 PEACHES, CANNED - MISBRANDING INVOLVING FOOD STANDARDS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.680 PINEAPPLE, CANNED, PINEAPPLE JUICE - ADULTERATION WITH MOLD. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.685 PINEAPPLE, CANNED. IMPORTED AND DOMESTIC - MISBRANDING INVOLVING FOOD STANDARDS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.690 PLUMS, CANNED - ADULTERATION WITH ROT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.700 DRIED PRUNES, DEHYDRATED LOW MOISTURE PRUNES, AND PITTED PRUNES - ADULTERATION INVOLVING INSECTS, DECOMPOSITION, DIRT, PITS, AND PIT FRAGMENTS. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.750 RAISINS - ADULTERATION INVOLVING MOLD, SAND, GRIT, & INSECTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.800 STANDARDIZED CANNED FRUIT - MISBRANDING INVOLVING IMPROPER DECLARATION OF PACKING MEDIUM. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 550.850 STRAWBERRIES. FROZEN, WHOLE, OR SLICED - ADULTERATION WITH SAND, MOLD. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.100 ALCOHOL. USE OF SYNTHETIC ALCOHOL IN FOODS. JAN 31, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.200 ADULTERATED FOOD MIXED WITH GOOD FOOD. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.250 STATEMENT OF POLICY FOR LABELING AND PREVENTING CROSS-CONTACT OF COMMON FOOD ALLERGENS (NEW 4/2001). NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.300 FOODS, EXCEPT DAIRY PRODUCTS - ADULTERATION WITH SALMONELLA. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.320 LISTERIA MONOCYTOGENES. FEB 2008.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.425 FOODS, ADULTERATION INVOLVING HARD OR SHARP FOREIGN OBJECTS. MAY 01, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.450 FOODS - ADULTERATION INVOLVING INFESTATION AND 1080 RODENTICIDE. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.500 ALL FOOD SANITATION (INCLUDING BACTERIOLOGICAL) INSPECTIONS - CLASSIFICATION OF ESTABLISHMENT. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.550 FOODS, STANDARDIZED. ENRICHED OR FORTIFIED - ADULTERATION INVOLVING MISBRANDING - POTENCY. FEB 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.600 FILTH FROM INSECTS, RODENTS, AND OTHER PESTS IN FOODS. NOV 13, 2002.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.650 RECONDITIONING FOODS BY DIVERSION FOR ANIMAL FEED. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.700 REVOCATION OF TOLERANCES FOR CANCELLED PESTICIDES (WITHDRAWN 1/8/2008). FEB 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.750 SEEDS FOR SPROUTING PRIOR TO FOOD USE, I.E., DRIED MUNG BEANS, ALFALFA SEEDS, ETC.. JAN 31, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.800 POLYSORBATES 20, 40, 60, 65, 80, 85 - COMMON OR USUAL NAMES. JAN 31, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.850 WATER DAMAGED FOOD PRODUCTS IN SCREW-TOP, CRIMPED-CAP AND SIMILAR CONTAINERS. FEB 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.875 WATER IN FOOD PRODUCTS (INGREDIENT OR ADULTERANT). JAN 31, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 555.880 RADIONUCLIDES IN IMPORTED FOODS - LEVELS OF CONCERN. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 560.100 IMPORTATION OF UNLABELED FOODS - EXEMPTION UNDER 21 CFR 101.100(D). JUL 18, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 560.200 COUNTRY OF ORIGIN LABELING. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 560.250 IMPORTS - IMPORTER CAN BE REQUIRED TO REVEAL IDENTITY OF INGREDIENTS. SEP 19, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 560.300 RECONDITIONING OF IMPORTED, INSECT INFESTED, INSECT DAMAGED OR MOLDY COFFEE BEANS. JUL 19, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 560.350 COFFEE AND COCOA BEAN SWEEPS. JUL 19, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 560.400 IMPORTED MILK AND CREAM - FEDERAL IMPORT MILK ACT. MAY 12, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 560.450 IMPORTED LOW-ACID CANNED FOODS (MANUFACTURER NOT REGISTERED AND/OR NO SCHEDULED PROCESS FILED). OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 560.500 JAMS, JELLIES AND RELATED PRODUCTS - IMPORTS. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.100 ACETIC ACID - USE IN FOODS - LABELING OF FOODS IN WHICH USED. FEB 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.200 FOODS - FPLA COMPLIANCE. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.300 FOODS - NET WEIGHT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.400 FOREIGN LANGUAGE DECLARATIONS ON FOOD LABELS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.450 IDENTITY OF FOODS - USE OF TERMS SUCH AS FRESH, FROZEN, DRIED, CANNED, ETC.. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.550 SAFETY AND LABELING OF WAXED (COATED) FRUITS AND VEGETABLES. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.600 PRESERVATIVES. USE IN NONSTANDARDIZED FOODS, LABEL DECLARATION. FEB 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.650 "PROCESSING" - USE OF TERM IN SECTION 405 OF THE FD&C ACT. JAN 31, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.700 LABELING OF FOOD BEARING RESIDUES OF PESTICIDE CHEMICALS. FEB 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.750 LABELING OF FOOD ARTICLES DISTRIBUTED SOLELY IN PUERTO RICO. FEB 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 562.800 VENDING MACHINE FOOD - LABELING. FEB 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 565.100 FDA JURISDICTION OVER MEAT AND POULTRY PRODUCTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 565.200 RED MEAT ADULTERATED WITH PCBS. NOV 10, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 567.100 ANTIPASTO, COMMON OR USUAL NAME. SEP 01, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 567.200 PORK AND BEANS AND SIMILAR BEAN PRODUCTS - LABELING. OCT 01, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 567.300 *BOUILLON, BOUILLON CUBES, GRANULATED BOUILLON. SEP 01, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 570.100 JORDAN ALMONDS - COMMON OR USUAL NAME. DEC 02, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 570.250 CASHEWS, INSECT INFESTED - RECONDITIONING. DEC 02, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 570.300 PEANUT BUTTER - ADULTERATION WITH FILTH. GRIT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 570.350 PEANUTS, SHELLED AND UNSHELLED - ADULTERATION WITH FILTH AND REJECT NUTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 570.425 TREE NUTS - ADULTERATION INVOLVING REJECTS (INSECT INFESTATION, MOLDY, RANCID, OTHERWISE DECOMPOSED, BLANKS, AND SHRIVELED). NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 570.450 TREE NUTS - ADULTERATION WITH FILTH, INVOLVING THE PRESENCE OF THE ORGANISM ESCHERICHIA COLI. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 570.550 RECONDITIONING - TREE NUTS CONTAMINATED WITH E. COLI. DEC 09, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 570.700 MIXED NUTS - MISBRANDING INVOLVING FOOD STANDARDS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 575.100 PESTICIDE RESIDUES IN FOOD AND FEED - ENFORCEMENT CRITERIA. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 578.100 STARCHES - COMMON OR USUAL NAMES. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 578.200 CORN MEAL - ADULTERATION BY INSECT AND RODENT FILTH. JUN 06, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 578.300 WHEAT - ADULTERATION BY INSECT AND RODENT FILTH. JUN 06, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 578.350 WHEAT FOR HUMAN CONSUMPTION - RECONDITIONING. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 578.400 TREATED GRAIN SEED - MERCURY RESIDUE. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 578.450 WHEAT FLOUR-ADULTERATION WITH INSECT FRAGMENTS AND RODENT HAIRS. DEC 31, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 578.500 DIMETHYLNITROSAMINE (DMNA) IN BARLEY MALT. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 578.600 UNAPPROVED ADDITIVES FOR EXPORTED GRAINS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 580.100 FOOD STORAGE AND WAREHOUSING-ADULTERATION-FILTH (DOMESTIC AND IMPORT). NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.100 ARTICHOKE, JERUSALEM ARTICHOKE - COMMON OR USUAL NAME. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.150 ASPARAGUS, CANNED OR FROZEN - ADULTERATION WITH INSECT FILTH. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.200 BEETS, CANNED - ADULTERATION WITH ROT. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.225 BLACK-EYED PEAS (COW PEAS, FIELD PEAS), DRIED-ADULTERATION WITH LYGUS BUG DAMAGE. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.260 BROCCOLI, FROZEN - ADULTERATION WITH INSECTS. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.275 BRUSSELS SPROUTS, FROZEN - ADULTERATION BY INSECTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.300 CORN, SWEET. CANNED - ADULTERATION BY CORN EAR WORMS, CORN BORERS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.325 CORN ON THE COB, CANNED - QUANTITY OF CONTENTS DECLARATION. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.350 CORN HUSKS (FOR TAMALES) - ADULTERATION WITH FILTH. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.400 COWPEAS (BLACK-EYED PEAS), CANNED (SUCCULENT PEAS) - ADULTERATION BY INSECTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.450 GREENS, CANNED - ADULTERATION BY MILDEW. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.475 CANNED GREEN BEANS AND CANNED WAX BEANS - MISBRANDING INVOLVING FOOD STANDARDS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.525: MUSHROOM MYCELIUM - FITNESS FOR FOOD. LABELING. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.575 PEAS AND BEANS, DRIED - ADULTERATION INVOLVING STORAGE, INSECT DAMAGE, ROCKS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.600 PEAS AND CARROTS, LABELING OF CANNED MIXTURE. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.625 CANNED PEAS - LABEL DESIGNATION OF SIZES. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.650 CANNED PIMENTOS AND RED SWEET PEPPERS - SEEDS SHOULD BE REMOVED. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.675 POPCORN - ADULTERATION WITH RODENT FILTH AND FIELD CORN. AUG 01, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.700 POTATO CHIPS - ADULTERATION WITH ROT. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.710 POTATO CHIPS, INGREDIENTS - LABELING. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.725 "PUMPKIN" - LABELING ARTICLES MADE FROM CERTAIN VARIETIES OF SQUASH. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.750 SAUERKRAUT - DEFINITION. ADULTERATION BY THRIPS. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.775 SPINACH, CANNED OR FROZEN - ADULTERATION INVOLVING INSECTS, DECOMPOSITION. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.800 SQUASH SEEDS - LABELING AS PUMPKIN SEEDS. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.825 SWEET POTATOES - DYEING OF YELLOW AND RED VARIETIES. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.875 TOMATOES - CANNED - MISBRANDING INVOLVING FOOD STANDARDS (PEEL). NOV 25, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.890 TOMATO PRODUCTS - ADULTERATION WITH DROSOPHILA FLY EGGS AND MAGGOTS. NOV 25, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 585.900 TOMATO PRODUCTS - ADULTERATION WITH MOLD. NOV 25, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 587.100 LABEL DECLARATION OF CERTIFICATION-EXEMPT COLOR ADDITIVES. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 587.200 UNCERTIFIED OR DELISTED COLORS IN FOODS FOR EXPORT - (E.G., FD&C RED #2). MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 587.300 COLOR ADDITIVES. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 590.300 DIRECT REFERENCE AUTHORITY FOR PSEUDOMONAS CONTAMINATION OF COSMETICS USED IN THE EYE AREA. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 590.400 NATURAL BRISTLE BRUSHES (I.E., HAIR BRUSHES, SHAVING BRUSHES) - NIT CONTAMINATION. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC 590.500 PACKAGING TECHNOLOGIES AND TAMPER-RESISTANT PACKAGING REQUIREMENTS FOR COSMETIC PRODUCTS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 100.100RESPONSIBILITY FOR REPORTING POSSIBLE OR POTENTIAL VIOLATIONS OF LAWS ADMINISTERED BY FDA, REGULATIONS ISSUED BY FDA, OTHER POSSIBLE OR POTENTIAL HAZARDS TO THE PUBLIC HEALTH. SEP 01, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 100.300 NON-FDA REGULATED PRODUCTS INVOLVING COMMUNICABLE DISEASE HAZARDS. SEP 01, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 100.350 FDA JURISDICTION ON INDIAN RESERVATIONS. AUG 31, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 100.500 - COMMON CARRIER AS A RELABELER, REPACKER, REPROCESSOR, ETC.. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 100.550 STATUS AND RESPONSIBILITIES OF CONTRACT STERILIZERS ENGAGED IN THE STERILIZATION OF DRUGS AND DEVICES. OCT 02, 2006.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 100.700GWQAP PRE-AWARD EVALUATION - INADEQUATE INFORMATION TO EVALUATE PROSPECTIVE SUPPLIER. APR 24, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 100.800 GUARANTIES OVER PRINTED SIGNATURES. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 100.950 INTERNATIONAL PARTNERSHIP AGREEMENTS FOR COMPLIANCE ACTIVITIES. JUN 28, 2000.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 110.200 EXPORT OF FDA REGULATED PRODUCTS FROM U.S. FOREIGN TRADE ZONES. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 110.500 FOOD AND DRUG GUARANTY - IMPORTS. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 110.600 FDA AUTHORITY OVER PRODUCTS OF FOREIGN ORIGIN LOCATED IN FOREIGN TRADE ZONES, BONDED WAREHOUSES OR ON BONDED CARRIERS. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 110.700 SEIZURES BY THE U.S. CUSTOMS SERVICE OF PROHIBITED ARTICLES OF FOREIGN ORIGIN NOT INTENDED FOR ENTRY INTO THE UNITED STATES. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 120.100 FRAUD, UNTRUE STATEMENTS OF MATERIAL FACTS, BRIBERY, AND ILLEGAL GRATUITIES. JUN 30, 1991.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 130.100 INSPECTIONAL AUTHORITY. REFUSAL TO PERMIT INSPECTION.. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 130.200 INSPECTION OF FIRMS WHEN LEGAL ACTION IS PENDING. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 130.300 FDA ACCESS TO RESULTS OF QUALITY ASSURANCE PROGRAM AUDITS AND INSPECTIONS. JUN 2007.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 130.400 USE OF MICROFICHE AND/OR MICROFILM FOR METHOD OF RECORDS RETENTION. NOV 07, 2004.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 140.100 SEIZURE OF BOOKS THAT CONSTITUTE MISLEADING LABELING. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 150.100 REQUESTS FOR PORTIONS OF INTERMEDIATE OR END PRODUCTS RESULTING FROM FDA SAMPLE ANALYSIS. MAR 22, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 150.500 ANALYTICAL METHODOLOGY USED BY FDA - DRUGS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 160.100 REGULATORY ACTIONS AND SMALL BUSINESS. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 160.200 FDA USE OF INCOME TAX INFORMATION FROM IRS IN COMPLIANCE ACTIVITY. APR 20, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 160.300 REQUESTS FOR RECORDS UNDER SECTION 703. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 160.400SECTION 305 MEETING BEFORE REPORT OF CRIMINAL VIOLATION. AUG 30, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 160.500 ANSWERING INQUIRIES ON STATUS OF CRIMINAL REFERRALS. JUL 31, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 160.600 PAYMENT OF EXPERT WITNESSES. OCT 15, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 160.700 RECONDITIONING OF FOODS ADULTERATED UNDER 402(A)(4). JUL 20, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 160.750 DRUG AND DEVICE PRODUCTS (INCLUDING BIOLOGICS AND ANIMAL DRUGS) FOUND IN VIOLATION OF GMPRS - RECONDITIONING. JUL 31, 1996.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 220.100 - IS SHIPMENT BIOLOGICALS FOR MEDICAL EMERGENCY. JUL 31, 2000.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 230.110- REGISTRATION OF BLOOD BANKS, OTHER FIRMS COLLECTING, MANUFACTURING, PREPARING OR PROCESSING HUMAN BLOOD OR BLOOD PRODUCTS. AUG 16, 2000.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 231.110-QUALITY CONTROL TESTING OF PLATELETS [ ] AND CRYOPRECIPITATED ANTIHEMOPHILIC FACTOR [ ]. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 270.100 FINAL CONTAINER LABELS - ALLERGENIC EXTRACTS CONTAINING GLYCERIN. REPORTING CHANGES. JUL 31, 2000.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 300.100 INSPECTION OF MANUFACTURERS OF DEVICE COMPONENTS. SEP 23, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 300.300 INEFFECTIVE DEVICES - 502(F)(I) LABELING REQUIREMENTS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 300.400 CONTAMINATION OF DEVICES LABELED AS STERILE. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 300.500 REPROCESSING OF SINGLE USE DEVICES. MAR 18, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 300.600 COMMERCIAL DISTRIBUTION WITH REGARD TO PREMARKET NOTIFICATION (SECTION 510(K)). SEP 23, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 300.750 CLASS III DEVICES SUBJECT TO 515(B) REQUIREMENTS. JUL 01, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 310.100 PACEMAKER REUSE. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 310.200 SPHYGMOMANOMETERS - RX LEGEND. SEP 26, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 310.210 BLOOD PRESSURE MEASUREMENT DEVICES (SPHYGMOMANOMETERS) - ACCURACY. FEB 18, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 315.100 ILLEGAL INTERSTATE COMMERCIAL SHIPMENT OF DENTURES (CPG RETITLED AND REVISED 5/19/2005). MAY 19, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 320.100 EAR PIERCING DEVICES. SEP 23, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 325.100 KARAYA GUM POWDER AND RELATED DEVICES FOR USE BY OSTOMATES. SEP 24, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 335.300 HYPNOTHERAPY DEVICES - SELF-HYPNOTIC TAPE RECORDINGS. JAN 01, 1900.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 335.500 RAZOR BLADES, MANICURING INSTRUMENTS - NOT CONSIDERED DEVICES UNDER 201(H). MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 335.800 CLINICAL THERMOMETER - ADULTERATION, MISBRANDING DEFECTS. MAY 31, 1991.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 345.100 CONDOMS. DEFECTS - CRITERIA FOR DIRECT REFERENCE SEIZURE. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 345.200 DIAPHRAGMS - RX DEVICES. SEP 24, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 345.300 MENSTRUAL SPONGES. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 350.100 PACKAGING TECHNOLOGIES AND TAMPER-RESISTANT PACKAGING REQUIREMENTS FOR CONTACT LENS SOLUTIONS AND TABLETS. NOV 21, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 355.100 CELLUTRON MACHINE - REVOKED ON 3/10/05. MAR 10, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 355.200 ELECTRICAL MUSCLE STIMULATORS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 355.300 ION GENERATING DEVICES. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 370.100 CYTOTOXIC TESTING FOR ALLERGIC DISEASES. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 390.100 DEFINITION OF "COMMERCE" - 21 CFR 1000.3(D). .
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 390.225 EARLY DEFECTS OR NONCOMPLIANCE - 21 CFR 1004.6. FEB 2013.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 390.300 ASSESSMENT OF CIVIL PENALTIES AGAINST MANUFACTURERS AND IMPORTERS OF ELECTRONIC PRODUCTS. APR 01, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 390.400 EXAMPLES OF ELECTRONIC PRODUCTS SUBJECT TO THE REPORTING REQUIREMENTS UNDER 21 CFR 1000.15(A). MAR 01, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 390.425 RECORDS AND REPORTS, APPLICABILITY - 21 CFR 1002.1. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 391.200 WARNING STATEMENT IN ADVERTISEMENTS FOR HIGH-INTENSITY MERCURY VAPOR DISCHARGE LAMPS THAT ARE NOT SELF-EXTINGUISHING (21 CFR 1040.30(E)(3)). MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 393.100 ENFORCEMENT POLICY FOR CERTAIN LASER LIGHT SHOWS, DISPLAYS, AND/OR DEVICES. (21 CFR 1040.10 AND 1040.11). MAR 01, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 393.200 LASER(S) AS MEDICAL DEVICES FOR FACELIFT, WRINKLE REMOVAL, ACUPUNCTURE, AURICULAR STIMULATION, ETC. (CPG 7133.21). MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 394.100 RETENTION OF MICROWAVE OVEN TEST RECORDS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 394.500 IMPORTATION OF TELEVISION PRODUCTS, MICROWAVE OVENS, AND INHERENT CLASS I LASER PRODUCTS FOR INVESTIGATION AND EVALUATION DURING DESIGN DEVELOPMENT. JUL 29, 2004.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 396.100 APPLICABILITY OF THE SUNLAMP PERFORMANCE STANDARD TO UVA TANNING PRODUCTS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 396.200 EXEMPTION FOR CERTAIN SUNLAMP PRODUCT PURCHASER RECORDS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 396.300 DEFECTIVE SUNTANNING BOOTHS AND BED. FEB 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 396.400 POLICY ON WARNED ON SUNLAMP PRODUCTS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 397.100 ACCURACY REQUIREMENTS FOR INDICATION OF TEMPORAL-MAXIMUM ULTRASONIC POWER, 21 CFR 1050.10(C)(1)(II). FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.100 DEFINITION OF GENERAL PURPOSE RADIOGRAPHIC X-RAY SYSTEM - 21 CFR 1020.30(B). FEB 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.200 HAZARDOUS DIAGNOSTIC X-RAY SYSTEMS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.300 REGISTRATION OF ASSEMBLERS OF DIAGNOSTIC X-RAY SYSTEMS AS DEVICE MANUFACTURERS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.325 REGULATORY ACTIONS AGAINST ASSEMBLERS NONCOMPLIANT DIAGNOSTIC X-RAY EQUIPMENT. FEB 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.350 REGULATORY ACTIONS AGAINST ASSEMBLERS OF X-RAY EQUIPMENT THAT FAIL TO FILE REPORTS OF ASSEMBLY. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.375 OBLIGATIONS OF FACTORY-BASED MANUFACTURERS AND ASSEMBLERS OF DIAGNOSTIC X-RAY EQUIPMENT UNDER THE PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY EQUIPMENT. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.400 AUTOMATIC ADJUSTMENT OF THE X-RAY FIELD SIZE TO THE SELECTED SPOT-FILM SIZE - 21 CFR 1020.31(G)(1). SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.425 OVERRIDE OF POSITIVE BEAM LIMITATION - 21 CFR 1020.31(G)(5). FEB 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.450 APPLICABILITY OF POSITIVE BEAM LIMITATION (PBL) REQUIREMENTS WHEN PBL IS PROVIDED ON "OTHER THAN STATIONARY GENERAL PURPOSE" RADIOGRAPHIC SYSTEM. JUL 31, 1983.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.600 CERTIFICATION AND IDENTIFICATION OF X-RAY COMPONENTS - SECTIONS 1010.2 AND 1020.30(E). FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 398.700 RELOADERS OF X-RAY TUBE HOUSING ASSEMBLIES, APPLICABILITY OF MEDICAL DEVICE ESTABLISHMENT REGISTRATION, DEVICE LISTING AND BIENNIAL INSPECTION. FEB 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.100 DRUGS, HUMAN - FAILURE TO REGISTER. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.200 CONSISTENT APPLICATION OF CGMP DETERMINATIONS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.210, RADIOFREQUENCY IDENTIFICATION FEASIBILITY STUDIES AND PILOT PROGRAMS FOR DRUGS. COMPLIANCE POLICY GUIDE. FEB 2012.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.325 CANDY "PILLS" REPRESENTATION AS DRUG. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.335 FRUCTOSE-CONTAINING DRUGS. MAY 22, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.500 IDENTICAL OR SIMILAR PRODUCT NAMES. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.600 DRUGS - DECLARATION OF QUANTITY OF ACTIVE INGREDIENT BY BOTH METRIC AND APOTHECARY SYSTEMS. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.700 DRUG PRODUCT ENTRIES IN PERIODIC PUBLICATIONS. AUG 01, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.800 COLLECTION AND CHARITABLE DISTRIBUTION OF DRUGS. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 400.900 CLASS I RECALLS OF PRESCRIPTION DRUGS. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 410.100 FINISHED DOSAGE FORM DRUG PRODUCTS IN BULK CONTAINERS - APPLICATIONS OF CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS. SEP 04, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 420.100 ADULTERATION OF DRUGS UNDER SECTION 501(B) AND 501(C) OF THE ACT. DIRECT REFERENCE SEIZURE AUTHORITY FOR ADULTERATED DRUGS UNDER SECTION 501(B). MAY 01, 1992.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 420.200 COMPENDIUM REVISIONS AND DELETIONS. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 420.400 PERFORMANCE OF TESTS FOR COMPENDIAL REQUIREMENTS ON COMPENDIAL PRODUCTS. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 420.500 INTERFERENCE WITH COMPENDIAL TESTS. .
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 425.100 COMPUTERIZED DRUG PROCESSING. CGMP APPLICABILITY TO HARDWARE AND SOFTWARE. SEP 04, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 425.200 COMPUTERIZED DRUG PROCESSING. VENDOR RESPONSIBILITY. SEP 04, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 425.300 COMPUTERIZED DRUG PROCESSING. SOURCE CODE FOR PROCESS CONTROL APPLICATION PROGRAMS. APR 15, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 425.400 COMPUTERIZED DRUG PROCESSING. INPUT/OUTPUT CHECKING. SEP 04, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 425.500 COMPUTERIZED DRUG PROCESSING. IDENTIFICATION OF "PERSONS" ON BATCH PRODUCTION AND CONTROL RECORDS. SEP 04, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 430.200 REPACKING OF DRUG PRODUCTS - TESTING/EXAMINATION UNDER CGMPS. JUL 01, 1981.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 430.300 LABELING SHIPPING CONTAINERS OF DRUGS. MAY 22, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 430.400 URINARY PREPARATIONS - MISBRANDING - LACK OF RX LEGEND AND CLAIMS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 440.100 MARKETED NEW DRUGS WITHOUT APPROVED NDAS AND ANDAS. SEP 2011.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 442.100 NEW DRUGS - EXPORT. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 444.100 RECOVERY OF INVESTIGATIONAL NEW DRUGS FROM CLINICAL INVESTIGATORS. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 446.100 REGULATORY ACTION REGARDING APPROVED NEW DRUGS AND ANTIBIOTIC DRUG PRODUCTS SUBJECTED TO ADDITIONAL PROCESSING OR OTHER MANIPULATIONS. JAN 18, 1991.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 448.100 RECONDITIONING OF NEW DRUGS WHICH DO NOT HAVE APPROVED NDAS/ANDAS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 450.100 CGMP ENFORCEMENT POLICY - OTC VS RX DRUGS. APR 01, 1982.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 450.200 DRUGS - GENERAL PROVISIONS AND ADMINISTRATIVE PROCEDURES FOR RECOGNITION AS SAFE AND EFFECTIVE. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 450.300 OTC DRUGS - GENERAL PROVISIONS AND ADMINISTRATIVE PROCEDURES FOR MARKETING COMBINATION PRODUCTS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 450.400 LABELING AND DISTRIBUTION OF OTC DRUGS IN VENDING MACHINES. MAY 22, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 450.500 TAMPER-RESISTANT PACKAGING REQUIREMENTS FOR CERTAIN OVER-THE-COUNTER HUMAN DRUG PRODUCTS. MAY 21, 1992.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 450.550 CONTROL AND ACCOUNTABILITY OF LABELING ASSOCIATED WITH TAMPER-RESISTANT PACKAGING OF OVER-THE-COUNTER DRUG PRODUCTS. MAR 01, 1983.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 454.100 OTC EAR DROP PREPARATIONS. MAY 22, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 455.100 INERT GLANDULAR PREPARATIONS (OTC), INADEQUATE FULL DISCLOSURE AND CLAIMS. MAY 22, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 456.100 NON-RX DRUGS ANTI-OBESITY PREPARATIONS. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 457.100 PANGAMIC ACID AND PANGAMIC ACID PRODUCTS UNSAFE FOR FOOD AND DRUG USE. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.100 HOSPITAL PHARMACIES - STATUS AS DRUG MANUFACTURER. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.300 RETURN OF UNUSED PRESCRIPTION DRUGS TO PHARMACY STOCK. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.400 COMPUTERIZED PRESCRIPTION RECORDKEEPING BY PHARMACIES. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.425 PRESCRIPTION STATUS WHEN TELEPHONED TO RECORDING MACHINE. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.450 STATUS OF MAIL-ORDER FILLING OF PRESCRIPTIONS. MAY 21, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.500 PRESCRIPTION DRUGS FOR SHIP'S MEDICINE CHESTS. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 460.600 CONTENT UNIFORMITY TESTING OF TABLETS AND CAPSULES. OCT 02, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 470.100 ORDERS FOR POST-APPROVAL RECORD REVIEWS. JUN 24, 1992.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 480.100 REQUIREMENTS FOR EXPIRATION DATING AND STABILITY TESTING. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 480.300 LACK OF EXPIRATION DATE OF STABILITY DATA. MAR 01, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 490.100 PROCESS VALIDATION REQUIREMENTS FOR DRUG PRODUCTS AND ACTIVE PHARMACEUTICAL INGREDIENTS SUBJECT TO PRE-MARKET APPROVAL. MAR 12, 2004.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 490.200 PARAMETERIC RELEASE OF PARENTERAL DRUG PRODUCTS TERMINALLY STERILIZED BY MOISTS HEAT. JUL 2012.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 527.300 DAIRY PRODUCT - MICROBIAL CONTAMINANTS AND ALKALINE PHOSPHATASE ACTIVITY. DEC 2010.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 540.275 CRABMEAT - FRESH AND FROZEN - ADULTERATION WITH FILTH, INVOLVING THE PRESENCE OF ESCHERICHIA COLI. APR 2016.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 540.370 FISH AND FISHERY PRODUCTS - DECOMPOSITION. JAN 2009.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 540.390 CANNED SHRIMP - LABELING, SIZE DESIGNATIONS AND CORRESPONDING COUNTS. OCT 29, 1989.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 540.420 RAW BREADED SHRIMP - MICROBIOLOGICAL CRITERIA FOR EVALUATING COMPLIANCE WITH CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 540.475 SNAPPER - LABELING. OCT 01, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 540.600 FISH, SHELLFISH, CRUSTACEANS AND OTHER AQUATIC ANIMALS - FRESH, FROZEN OR PROCESSED - METHYL MERCURY. FEB 2007.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 540.700 LABELING OF PROCESSED AND BLENDED SEAFOOD PRODUCTS MADE PRIMARILY WITH FISH PROTEIN. DEC 2014.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 540.700 PROCESSED AND/OR BLENDED SEAFOOD PRODUCTS. NOV 2008.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 550.050 CANNED ACKEE, FROZEN ACKEE, AND OTHER ACKEE PRODUCTS - HYPOGLYCIN A TOXIN. APR 2014.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 550.155 APRICOT, PEACH AND PEAR NECTARS AND PUREES - ADULTERATION WITH MOLD. NOV 29, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 560.600 CLAMS, MUSSELS, OYSTERS. FRESH OR FROZEN - ADULTERATION BY BACTERIOLOGICAL CONTAMINATION. NOV 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 585.500 MUSHROOMS, CANNED OR DRIED (FREEZE-DRIED OR DEHYDRATED) - ADULTERATION INVOLVING MAGGOTS, MITES, DECOMPOSITION. NOV 28, 2005.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 585.850 SWEET POTATOES - SIRUP PACK. DEC 08, 1988.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 607.100 - ADEQUATE DIRECTIONS FOR USE (SPECIES DESIGNATION) - ANIMAL DRUGS AND VETERINARY DEVICES. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 615.200 PROPER DRUG USE AND RESIDUE AVOIDANCE BY NON-VETERINARIANS. JUL 08, 1993.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 615.300RESPONSIBILITY FOR ILLEGAL DRUG RESIDUES IN MEAT, MILK AND EGGS. JUN 30, 1982.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 625.200 AVAILABILITY OF BULK CHEMICALS FOR ANIMAL DRUG USE. SEP 30, 1980.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 625.600ORDERS FOR POST-APPROVAL RECORD REVIEWS. JUN 24, 1992.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 638.100 PROCESS VALIDATION REQUIREMENTS FOR DRUG PRODUCTS SUBJECT TO PRE-MARKET APPROVAL. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 642.100 DRUGS FOR ODOR CONTROL AND CONCEPTION IN PET ANIMALS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 650.100 ANIMAL DRUGS FOR EUTHANASIA. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 654.200 TEAT DIPS AND UDDER WASHES FOR DAIRY COWS AND GOATS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 655.100 DEVICES FOR USE IN ANIMALS. JUN 01, 1987.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 665.100 COMMON OR USUAL NAMES FOR ANIMAL FEED INGREDIENTS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 670.500 AMMONIATED COTTONSEED MEAL - INTERPRETATION OF 21 CFR. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 675.100 DIVERSION OF CONTAMINATED FOOD FOR ANIMAL USE. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 675.200 DIVERSION OF ADULTERATED FOOD TO ACCEPTABLE ANIMAL FEED USE. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 675.300 MOISTURE DAMAGED GRAIN. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 680.100 TRACERS IN ANIMAL FEED. APR 04, 1993.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 680.400 MEDICATED FEEDS - COMBINED BATCHES. MAY 31, 1986.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 680.500 UNSAFE CONTAMINATION OF ANIMAL FEED FROM DRUG CARRYOVER. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 680.600 SEQUENCING AS A MEANS TO PREVENT UNSAFE DRUG CONTAMINATION IN THE PRODUCTION, STORAGE, AND DISTRIBUTION OF FEEDS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 685.100 RECYCLED ANIMAL WASTE. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 687.500 SILAGE INGREDIENTS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 688.100 UNAPPROVED ADDITIVES FOR EXPORTED GRAINS. JAN 31, 1982.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC. 689.100 DIRECT-FED MICROBIAL PRODUCTS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. CPG SEC.140.500 METRIC DECLARATIONS OF QUANTITY OF CONTENTS ON PRODUCT LABELS. FEB 28, 1995.
US FDA. COMPLIANCE POLICY GUIDE. SAMPLE WHO CERTIFICATE FOR QUALITY OF A PHARMACEUTICAL PRODUCT.
US FDA. CONCEPT PAPER. PDUFA PILOT PROJECT. PROPRIETARY NAME REVIEW. SEP 2008.
US FDA. CORRECTIVE ACTIONS FOR ELECTRONIC PRODUCTS. ACCESSED : MAR 23, 2022.
US FDA. CPG SEC. 500.500 GUIDANCE LEVELS FOR 3-MCPD(3-CHLORO-1,2-PROPANEDIOL) IN ACID-HYDROLYZED PROTEIN AND ASIAN-STYLE SAUCES. MAR 14, 2008.
US FDA. CROHN’S DISEASE : DEVELOPING DRUGS FOR TREATMENT. APR 2022.
US FDA. CTP COMPLIANCE & ENFORCEMENT. ACCESSED : MAR 23, 2022.
US FDA. CURRICULUM MATERIALS FOR HEALTH CARE DEGREE PROGRAMS - BIOSIMILARS. ACCESSED : DEC 19, 2021.
US FDA. DEVICE LABELING. ACCESSED : APR 1, 2022.
US FDA. DEVICE REGISTRATION AND LISTING. ACCESSED : MAR 23, 2022.
US FDA. DRAFT COMPLIANCE POLICY GUIDE. CPG SEC. 575.100 PESTICIDE CHEMICAL RESIDUES IN FOOD - ENFORCEMENT CRITERIA (CPG 7141.01). COMPLIANCE POLICY GUIDE. JAN 2008.
US FDA. DRAFT GUIDANCE. 1993 DRAFT REDBOOK II. AUG 01, 1993.
US FDA. DRAFT GUIDANCE. A RISK-BASED APPROACH TO MONITORING OF CLINICAL INVESTIGATIONS. QUESTIONS AND ANSWERS. MAR 2019.
US FDA. DRAFT GUIDANCE. ACTION LEVELS FOR LEAD IN FOOD INTENDED FOR BABIES AND YOUNG CHILDREN. JAN 2023.
US FDA. DRAFT GUIDANCE. ADJUSTING FOR COVARIATES IN RANDOMIZED CLINICAL TRIALS FOR DRUGS AND BIOLOGICAL PRODUCTS. MAY 2021. REV. 1.
US FDA. DRAFT GUIDANCE. ALCOHOLISM : DEVELOPING DRUGS FOR TREATMENT. FEB 2015.
US FDA. DRAFT GUIDANCE. ANDA SUBMISSIONS - REFUSE-TO-RECEIVE STANDARDS : QUESTIONS AND ANSWERS. OCT 2017.
US FDA. DRAFT GUIDANCE. ANDAS : PRE-SUBMISSION OF FACILITY CORRESPONDENCE RELATED TO PRIORITIZED GENERIC DRUG SUBMISSIONS. DEC 2022. REV. 2.
US FDA. DRAFT GUIDANCE. ANNUAL REPORTING BY PRESCRIPTIOND DRUG WHOLESALE DISTRIBUTORS AND THIRD-PARTY LOGISTICS PROVIDERS : QUESTIONS AND ANSWERS. JAN 2017.
US FDA. DRAFT GUIDANCE. ANNUAL STATUS REPORT INFORMATION AND OTHER SUBMISSIONS FOR POSTMARKETING REQUIREMENTS AND COMMITMENTS : USING FORMS FDA 3988 AND FDA 3989. OCT 2020.
US FDA. DRAFT GUIDANCE. ANTIBACTERIAL THERAPIES FOR PATIENTS WITH AN UNMET MEDICAL NEED FOR THE TREATMENT OF SERIOUS BACTERIAL DISEASES - QUESTIONS AND ANSWERS (REVISION 1). MAY 2022. REV. 1.
US FDA. DRAFT GUIDANCE. APPEAL OPTIONS AVAILABLE TO MAMMOGRAPHY FACILITIES CONCERNING ADVERSE ACCREDITATION DECISIONS, SUSPENSION / REVOCATION OF CERTIFICATES, OR PATIENT AND PHYSICIAN NOTIFICATION ORDERS. JUL 21, 2020.
US FDA. DRAFT GUIDANCE. APPLICATION OF THE “SOLELY ENGAGED” EXEMPTIONS IN PARTS 117 AND 507. OCT 2017.
US FDA. DRAFT GUIDANCE. APPLICATIONS COVERED BY SECTION 505(B)(2). DEC 08, 1999.
US FDA. DRAFT GUIDANCE. APPLICATIONS FOR PREMARKET REVIEW OF NEW TOBACCO PRODUCTS. SEP 2011.
US FDA. DRAFT GUIDANCE. ARSENIC IN APPLE JUICE : ACTION LEVEL. JUL 2013.
US FDA. DRAFT GUIDANCE. ASSESSING ADHESION WITH TRANSDERMAL AND TOPICAL DELIVERY SYSTEMS FOR ANDAS. OCT 2018.
US FDA. DRAFT GUIDANCE. ASSESSING THE CREDIBILITY OF COMPUTATIONAL MODELING AND SIMULATION IN MEDICAL DEVICE SUBMISSIONS. DEC 23, 2021.
US FDA. DRAFT GUIDANCE. ASSESSING THE IRRITATION AND SENSITIZATION POTENTIAL OF TRANSDERMAL AND TOPICAL DELIVERY SYSTEMS FOR ANDAS. OCT 2018.
US FDA. DRAFT GUIDANCE. ASSESSING USER FEES UNDER THE OVER-THE-COUNTER MONOGRAPH DRUG USER FEE PROGRAM. OCT 2022.
US FDA. DRAFT GUIDANCE. ASSESSMENT OF ADHESION FOR TOPICAL AND TRANSDERMAL SYSTEMS SUBMITTED IN NEW DRUG APPLICATIONS. JUL 2021.
US FDA. DRAFT GUIDANCE. ASSESSMENT OF PRESSOR EFFECTS OF DRUGS. FEB 2022.
US FDA. DRAFT GUIDANCE. ATTACHMENT TO GUIDANCE ON QUALIFICATION PROCESS FOR DRUG DEVELOPMENT TOOLS. EVALUATING RESPIRATORY SYMPTOMS IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE, A PATIENT-REPORTED OUTCOME INSTRUMENT FOR THE MEASUREMENT OF SEVERITY OF RESPIRATORY SYSTEMS IN STABLE COPD. QUALIFICATION FOR EXPLORATORY USE. MAR 2016.
US FDA. DRAFT GUIDANCE. ATTACHMENT TO GUIDANCE ON QUALIFICATION PROCESS FOR DRUG DEVELOPMENT TOOLS. QUALIFICATION OF EXACERBATIONS OF CHRONIC PULMONARY DISEASE TOOL FOR MEASUREMENT OF SYMPTOMS OF ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE. JAN 2014.
US FDA. DRAFT GUIDANCE. ATTENTION DEFICIT HYPERACTIVITY DISORDER : DEVELOPING STIMULANT DRUGS FOR TREATMENT. MAY 2019.
US FDA. DRAFT GUIDANCE. BENEFIT-RISK ASSESSMENT FOR NEW DRUG AND BIOLOGICAL PRODUCTS. SEP 2021.
US FDA. DRAFT GUIDANCE. BENEFIT-RISK CONSIDERATIONS FOR PRODUCT QUALITY ASSESSMENTS. MAY 2022.
US FDA. DRAFT GUIDANCE. BEST PRACTICES IN DEVELOPING PROPRIETARY NAMES FOR HUMAN NONPRESCRIPTION DRUG PRODUCTS. DEC 2020.
US FDA. DRAFT GUIDANCE. BEST PRACTICES IN DRUG AND BIOLOGICAL PRODUCT POSTMARKET SAFETY SURVEILLANCE FOR FDA STAFF. NOV 2019.
US FDA. DRAFT GUIDANCE. BIOAVAILABIILTY AND BIOEQUIVALENCE STUDIES SUBMITTED IN NDAS OR INDS - GENERAL CONSIDERATIONS. MAR 2014.
US FDA. DRAFT GUIDANCE. BIOAVAILABILITY AND BIOEQUIVALENCE STUDIES FOR NASAL AEROSOLS AND NASAL SPRAYS FOR LOCAL ACTION. APR 03, 2003.
US FDA. DRAFT GUIDANCE. BIOEQUIVALENCE STUDIES WITH PHARMACOKINETIC ENDPOINTS FOR DRUGS SUBMITTED UNDER AN ANDA. AUG 2021.
US FDA. DRAFT GUIDANCE. BIOMARKER QUALIFICATION : EVIDENTIARY FRAMEWORK. DEC 2018.
US FDA. DRAFT GUIDANCE. BIOSIMILARITY AND INTERCHANGEABILITY : ADDITIONAL DRAFT Q&AS ON BIOSIMILAR DEVELOPMENT AND THE BPCI ACT. NOV 2020.
US FDA. DRAFT GUIDANCE. BIOSIMILARS AND INTERCHANGEABLE BIOSIMILARS : LICENSURE FOR FEWER THAN ALL CONDITIONS OF USE FOR WHICH THE REFERENCE PRODUCT HAS BEEN LICENSED. FEB 2020.
US FDA. DRAFT GUIDANCE. BLOOD PRESSURE AND PULSE DONOR ELIGIBILITY REQUIREMENTS - COMPLIANCE POLICY. MAY 2022.
US FDA. DRAFT GUIDANCE. BOWEL CLEANSING FOR COLONSCOPY: EFFICACY AND SAFETY CONSIDERATIONS FOR DEVELOPING NEW PRODUCTS. DEC 2021.
US FDA. DRAFT GUIDANCE. BRIDGING FOR DRUG-DEVICE AND BIOLOGIC-DEVICE COMBINATION PRODUCTS. DEC 2019.
US FDA. DRAFT GUIDANCE. BRIEF SUMMARY AND ADEQUATE DIRECTIONS FOR USE : DISCLOSING RISK INFORMATION IN CONSUMER-DIRECTED PRINT ADVERTISEMENTS AND PROMOTIONAL LABELING FOR PRESCRIPTION DRUGS. AUG 2015. REV. 2.
US FDA. DRAFT GUIDANCE. CALORIE LABELING OF ARTICLES OF FOOD IN VENDING MACHINES. AUG 2016.
US FDA. DRAFT GUIDANCE. CANCER CLINICAL TRIAL ELIGIBILITY CRITERIA : AVAILABLE THERAPY IN NON-CURATIVE SETTINGS. JUN 2021.
US FDA. DRAFT GUIDANCE. CDER’S PROGRAM FOR THE RECOGNITION OF VOLUNTARY CONSENSUS STANDARDS RELATED TO PHARMACEUTICAL QUALITY. FEB 2019.
US FDA. DRAFT GUIDANCE. CELIAC DISEASE : DEVELOPING DRUGS FOR ADJUNCTIVE TREATMENT TO A GLUTEN-FREE DIET. APR 2022.
US FDA. DRAFT GUIDANCE. CERTIFICATION PROCESS FOR DESIGNATED MEDICAL GASES. NOV 2015. REV. 1.
US FDA. DRAFT GUIDANCE. CHARACTERIZING, COLLECTING, AND REPORTING IMMUNE-MEDIATED ADVERSE REACTIONS IN CANCER IMMUNOTHERAPEUTIC CLINICAL TRIALS. OCT 2022.
US FDA. DRAFT GUIDANCE. CHARGING FOR INVESTIGATIONAL DRUGS UNDER AN IND - QUESTIONS AND ANSWERS. AUG 2022. REV 1.
US FDA. DRAFT GUIDANCE. CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING : DEVELOPING DRUGS FOR PREVENTION. MAY 2021.
US FDA. DRAFT GUIDANCE. CHRONIC FATIGUE SYNDROME / MYALGIC ENCEPHALOMYELITIS : DEVELOPING DRUG PRODUCTS FOR TREATMENT. MAR 2014.
US FDA. DRAFT GUIDANCE. CHRONIC HEPATITIS D VIRUS INFECTION : DEVELOPING DRUGS FOR TREATMENT. OCT 2019.
US FDA. DRAFT GUIDANCE. CIRCUMSTANCES THAT CONSTITUTE DELAYING, DENYING, LIMITING, OR REFUSING A DRUG OR DEVICE INSPECTION. DEC 2022.
US FDA. DRAFT GUIDANCE. CLARIFICATION OF RADIATION CONTROL REGULATIONS FOR MANUFACTURERS OF DIAGNOSTIC X-RAY EQUIPMENT. DEC 17, 2018.
US FDA. DRAFT GUIDANCE. CLASSIFICATION OF ACTIVITIES AS HARVESTING, PACKING, HOLDING, OR MANUFACTURING / PROCESSING FOR FARMS AND FACILITIES. AUG 2016.
US FDA. DRAFT GUIDANCE. CLINICAL DRUG INTERACTION STUDIES WITH COMBINED ORAL CONTRACEPTIVES. NOV 2020.
US FDA. DRAFT GUIDANCE. CLINICAL IMMUNOGENICITY CONSIDERATIONS FOR BIOSIMILAR AND INTERCHANGEABLE INSULIN PRODUCTS. NOV 2019.
US FDA. DRAFT GUIDANCE. CLINICAL LACTATION STUDIES : CONSIDERATIONS FOR STUDY DESIGN. MAY 2019.
US FDA. DRAFT GUIDANCE. CLINICAL PHARMACOLOGY CONSIDERATIONS FOR ANTIBODY-DRUG CONJUGATES. SEP 2022.
US FDA. DRAFT GUIDANCE. CLINICAL PHARMACOLOGY CONSIDERATIONS FOR HUMAN RADIOLABELED MASS BALANCED STUDIES. MAY 2022.
US FDA. DRAFT GUIDANCE. CLINICAL PHARMACOLOGY CONSIDERATIONS FOR THE DEVELOPMENT OF OLIGONUCLEOTIDE THERAPEUTICS. JUN 2022.
US FDA. DRAFT GUIDANCE. CLINICAL TRIAL CONSIDERATIONS TO SUPPORT ACCELERATED APPROVAL OF ONCOLOGY THERAPEUTICS. MAR 2023.
US FDA. DRAFT GUIDANCE. CLOSTRIDIODES DIFFICILE INFECTION : DEVELOPING DRUGS FOR TREATMENT, REDUCTION OF RECURRENCE, AND PREVENTION. OCT 2022.
US FDA. DRAFT GUIDANCE. COLLECTING AND PROVIDING 702(B) PORTIONS OF FDA OFFICIAL SAMPLES. QUESTIONS AND ANSWERS. JAN 2022.
US FDA. DRAFT GUIDANCE. COMPARABILITY PROTOCOLS FOR HUMAN DRUGS AND BIOLOGICS : CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION. APR 2016. REV. 1.
US FDA. DRAFT GUIDANCE. COMPARATIVE ANALYSES AND RELATED COMPARATIVE USE HUMAN FACTORS STUDIES FOR A DRUG-DEVICE COMBINATION PRODUCT SUBMITTED IN AN ANDA. JAN 2017.
US FDA. DRAFT GUIDANCE. COMPLEMENTARY AND ALTERNATIVE MEDICINE PRODUCTS AND THEIR REGULATION BY THE FOOD AND DRUG ADMINISTRAITON. DEC 2006.
US FDA. DRAFT GUIDANCE. COMPLIANCE POLICY GUIDE. SEC. 540.275 CRABMEAT - FRESH AND FROZEN. ADULTERATION WITH FILTH, INVOLVING THE PRESENCE OF ESCHERICHIA COLI. DEC 2014.
US FDA. DRAFT GUIDANCE. COMPLIANCE POLICY REGARDING BLOOD AND BLOOD COMPONENT DONATION SUITABILITY, DONOR ELIGIBILITY AND SOURCE PLASMA QUARANTINE HOLD REQUIREMENTS. MAY 2022.
US FDA. DRAFT GUIDANCE. COMPLIANCE WITH AND RECOMMENDATIONS FOR IMPLEMENTATION OF THE STANDARDS FOR THE GORWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION FOR SPROUT OPERATIONS. JAN 2017.
US FDA. DRAFT GUIDANCE. COMPUTER SOFTWARE ASSURANCE FOR PRODUCTION AND QUALITY SYSTEM SOFTWARE. SEP 13, 2022.
US FDA. DRAFT GUIDANCE. CONDUCTING REMOTE REGULATORY ASSESSMENTS. QUESTIONS AND ANSWERS. JUL 2022.
US FDA. DRAFT GUIDANCE. CONSIDERATIONS FOR LONG-TERM CLINICAL NEURODEVEOPMENTAL SAFETY STUDIES IN NEONATAL PRODUCT DEVELOPMENT. FEB 2023.
US FDA. DRAFT GUIDANCE. CONSIDERATIONS FOR RESCINDING BREAKTHROUGH THERAPY DESIGNATION. JUN 2022.
US FDA. DRAFT GUIDANCE. CONSIDERATIONS FOR THE DESIGN AND CONDUCT OF EXTERNALLY CONTROLLED TRIALS FOR DRUGS AND BIOLOGICAL PRODUCTS. FEB 2023.
US FDA. DRAFT GUIDANCE. CONSIDERATIONS FOR THE DEVELOPMENT OF CHIMERIC ANTIGEN RECEPTOR (CAR) T CELL PRODUCTS. MAR 2022.
US FDA. DRAFT GUIDANCE. CONSIDERATIONS FOR THE USE OF REAL-WORLD DATA AND REAL-WORLD EVIDENCE TO SUPPORT REGULATORY DECISION-MAKING FOR DRUG AND BIOLOGICAL PRODUCTS. DEC 2021.
US FDA. DRAFT GUIDANCE. CONSIDERATIONS FOR WAIVER REQUESTS FOR PH ADJUSTERS IN GENERIC DRUG PRODUCTS INTENDED FOR PARENTERAL, OPHTHALMIC, OR OTIC USE. APR 2022.
US FDA. DRAFT GUIDANCE. CONTACT DERMATITIS FROM TOPICAL DRUG PRODUCTS FOR CUTANEOUS APPLICATION : HUMAN SAFETY ASSESSMENT. MAR 2020.
US FDA. DRAFT GUIDANCE. CONTENT OF HUMAN FACTORS INFORMATION IN MEDICAL DEVICE MARKETING SUBMISSIONS. DEC 9, 2022.
US FDA. DRAFT GUIDANCE. CONTENT OF PREMARKET SUBMISSIONS FOR DEVICE SOFTWARE FUNCTIONS. NOV 4, 2021.
US FDA. DRAFT GUIDANCE. CONTENTS OF A COMPLETE SUBMISSION FOR THRESHOLD ANALYSES AND HUMAN FACTORS SUBMISSIONS TO DRUG AND BIOOGIC APPLICATIONS. SEP 2018.
US FDA. DRAFT GUIDANCE. CONTROL OF LISTERIA MONOCYTOGENES IN READY-TO-EAT FOODS. JAN 2017.
US FDA. DRAFT GUIDANCE. CONTROLLED CORRESPONDENCE RELATED TO GENERIC DRUG DEVELOPMENT. DEC 2022. REV. 1.
US FDA. DRAFT GUIDANCE. CORE PATIENT-REPORTED OUTCOMES IN CANCER CLINICAL TRIALS. JUN 2021.
US FDA. DRAFT GUIDANCE. CORONARY DRUG-ELUTING STENTS - NONCLINICAL AND CLINICAL STUDIES. COMPANION DOCUMENT. MAR 2008.
US FDA. DRAFT GUIDANCE. CORONARY DRUG-ELUTING STENTS - NONCLINICAL AND CLINICAL STUDIES. MAR 2008.
US FDA. DRAFT GUIDANCE. COSMETIC GOOD MANUFACTURING PRACTICES. JUN 2013.
US FDA. DRAFT GUIDANCE. CURRENT GOOD MANUFACTURING PRACTICE FOR MEDICAL GASES. JUN 2017.
US FDA. DRAFT GUIDANCE. CURRENT GOOD MANUFACTURING PRACTICE. GUIDANCE FOR HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES UNDER SECTION 503B OF THE FD&C ACT. JAN 2020. REV. 2.
US FDA. DRAFT GUIDANCE. CVM GFI #109 (VICH GL15) EFFECTIVENESS OF ANTHELMINTICS: SPECIFIC RECOMMENDATIONS FOR EQUINE. AUG 2022.
US FDA. DRAFT GUIDANCE. CVM GFI #110 (VICH GL16) EFFECTIVENESS OF ANTHELMINTICS: SPECIFIC RECOMMENDATIONS FOR PORCINE. AUG 2022.
US FDA. DRAFT GUIDANCE. CVM GFI #111 (VICH GL19) EFFECTIVENESS OF ANTHELMINTICS: SPECIFIC RECOMMENDATIONS FOR CANINE. AUG 2022.
US FDA. DRAFT GUIDANCE. CVM GFI #113 (VICH GL20) EFFECTIVENESS OF ANTHELMINTICS: SPECIFIC RECOMMENDATIONS FOR FELINE. AUG 2022.
US FDA. DRAFT GUIDANCE. CVM GFI #114 (VICH GL21) EFFECTIVENESS OF ANTHELMINTICS: SPECIFIC RECOMMENDATIONS FOR POULTRY-GALLUS GALLUS. AUG 2022.
US FDA. DRAFT GUIDANCE. CVM GFI #117 (VICH GL24) MANAGEMENT OF ADVERSE EVENT REPORTS (AER'S). MAY 01, 2006.
US FDA. DRAFT GUIDANCE. CVM GFI #142 (VICH GL29) PHARMACOVIGILANCE OF VETERINARY MEDICINAL PRODUCTS: MANAGEMENT OF PERIODIC SUMMARY UPDATE REPORTS (PSUS). DEC 06, 2001.
US FDA. DRAFT GUIDANCE. CVM GFI #152 EVALUATING THE SAFETY OF ANTIMICROBIAL NEW ANIMAL DRUGS WITH REGARD TO THEIR MICROBIOLOGICAL EFFECTS ON BACTERIA OF HUMAN HEALTH CONCERN. JAN 2023.
US FDA. DRAFT GUIDANCE. CVM GFI #90 (VICH GL7) EFFECTIVENESS OF ANTHELMINTICS: GENERAL RECOMMENDATIONS. AUG 2022.
US FDA. DRAFT GUIDANCE. CVM GFI #95 (VICH GL12) EFFICACY OF ANTHELMINTICS:SPECIFIC RECOMMENDATIONS FOR BOVINES. AUG 2022.
US FDA. DRAFT GUIDANCE. CVM GFI #96 (VICH GL13) EFFICACY OF ANTHELMINTICS: SPECIFIC RECOMMENDATIONS FOR OVINES. AUG 2022.
US FDA. DRAFT GUIDANCE. CVM GFI #97 (VICH GL14) EFFICACY OF ANTHELMINTICS: SPECIFIC RECOMMENDATIONS FOR CAPRINES. AUG 2022.
US FDA. DRAFT GUIDANCE. CYBERSECURITY IN MEDICAL DEVICES : QUALITY SYSTEM CONSIDERATIONS AND CONTENT OF PREMARKET SUBMISSIONS. APR 8, 2022.
US FDA. DRAFT GUIDANCE. DATA STANDARDS FOR DRUG AND BIOLOGICAL PRODUCT SUBMISSIONS CONTAINING REAL-WORLD DATA. OCT 2021.
US FDA. DRAFT GUIDANCE. DEMONSTRATING SUBSTANTIAL EVIDENCE OF EFFECTIVENESS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS. DEC 2019.
US FDA. DRAFT GUIDANCE. DESCRIBING A HAZARD THAT NEEDS CONTROL IN DOCUMENTS ACCOMPANYING THE FOOD, AS REQUIRED BY FOUR RULES IMPLEMENTING THE FDA FOOD SAFETY MODERNIZATION ACT. OCT 2016.
US FDA. DRAFT GUIDANCE. DEVELOPING AND SUBMITTING PROPOSED DRAFT GUIDANCE RELATING TO PATIENT EXPERIENCE DATA. DEC 2018.
US FDA. DRAFT GUIDANCE. DEVELOPING PRODUCTS FOR WEIGHT MANAGEMENT. FEB 2007. REV. 1.
US FDA. DRAFT GUIDANCE. DEVELOPMENT OF A SHARED SYSTEM REMS. JUN 2018.
US FDA. DRAFT GUIDANCE. DEVELOPMENT OF LOCAL ANESTHETIC DRUG PRODUCTS WITH PROLONGED DURATION OF EFFECT. MAR 2023.
US FDA. DRAFT GUIDANCE. DEVELOPMENT OF LOCALLY APPLIED CORTICOSTEROID PRODUCTS FOR THE SHORT-TERM TREATMENT OF SYMPTOMS ASSOCIATED WITH INTERNAL OR EXTERNAL HEMORRHOIDS. DEC 2019.
US FDA. DRAFT GUIDANCE. DEVELOPMENT OF NON-OPIOID ANALGESICS FOR ACUTE PAIN. FEB 2022.
US FDA. DRAFT GUIDANCE. DEVELOPMENT OF THERAPEUTIC PROTEIN BIOSIMILARS : COMPARATIVE ANALYTICAL ASSESSMENT AND OTHER QUALITY-RELATED CONSIDERATIONS. MAY 2019.
US FDA. DRAFT GUIDANCE. DIETARY SUPPLEMENTS : NEW DIETARY INGREDIENT NOTIFICATIONS AND RELATED ISSUES. AUG 2016.
US FDA. DRAFT GUIDANCE. DIGITAL HEALTH TECHNOLOGIES FOR REMOTE DATA ACQUISITION IN CLINICAL INVESTIGATIONS. DEC 2021.
US FDA. DRAFT GUIDANCE. DISTRIBUTING SCIENTIFIC AND MEDICAL PUBLICATIONS ON RISK INFORMATION FOR APPROVED PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS - RECOMMENDED PRACTICES. JUN 2014.
US FDA. DRAFT GUIDANCE. DIVERSITY PLANS TO IMPROVE ENROLLMENT OF PARTICIPANT FROM UNDERREPRESENTED RACIAL AND ETHNIC POPULATIONS IN CLINICAL TRIALS. APR 2022.
US FDA. DRAFT GUIDANCE. DOSAGE AND ADMINISTRATION SECTION OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. JAN 2023. REV. 1.
US FDA. DRAFT GUIDANCE. DRAFT REGULATORY PROCEDURES MANUAL CHAPTER 9 SUBCHAPTER ON RECOMMENDING CUSTOMS' SEIZURE AND DESTRUCTION OF IMPORTED HUMAN AND ANIMAL FOOD THAT HAS NOT BEEN RECONDITIONED. NOV 05, 2002.
US FDA. DRAFT GUIDANCE. DRUG ABUSE AND DEPENDENCE SECTION OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. JUL 2019.
US FDA. DRAFT GUIDANCE. DRUG MASTER FILES. OCT 2019. REV. 1.
US FDA. DRAFT GUIDANCE. DRUG-DRUG INTERACTION ASSESSMENT FOR THERAPEUTIC PROTEINS. AUG 2020.
US FDA. DRAFT GUIDANCE. DRY EYE : DEVELOPING DRUGS FOR TREATMENT. DEC 2020.
US FDA. DRAFT GUIDANCE. DSCSA IMPLEMENTATION : ANNUAL REPORTING PRESCRIPTION DRUG WHOLESALE DISTRIBUTORS AND THIRD-PARTY LOGISTICS PROVIDERS. DEC 2014.
US FDA. DRAFT GUIDANCE. DSCSA STANDARDS FOR THE INTEROPERABLE EXCHANGE OF INFORMATION FOR TRACING OF CERTAIN HUMAN, FINISHED, PRESCRIPTION DRUGS : HOW TO EXCHANGE PRODUCT TRACING INFORMATION. JUL 2022. REV. 1.
US FDA. DRAFT GUIDANCE. E11A PEDIATRIC EXTRAPOLATION. AUG 2022.
US FDA. DRAFT GUIDANCE. E12A PRINCIPLES FOR CLINICAL EVALUATION OF NEW ANTIHYPERTENSIVE DRUGS. AUG 09, 2000.
US FDA. DRAFT GUIDANCE. E19 OPTIMISATION OF SAFETY DATA COLLECTION. APR 3, 2019.
US FDA. DRAFT GUIDANCE. EARLY ALZHEIMER’S DISEASE : DEVELOPING DRUGS FOR TREATMENT. FEB 2018. REV. 1.
US FDA. DRAFT GUIDANCE. EARLY LYME DISEASE AS MANIFESTED BY ERYTHEMA MIGRANS : DEVELOPING DRUGS FOR TREATMENT. FEB 2023.
US FDA. DRAFT GUIDANCE. ECTD V4.0 IMPLEMENTATION PACKAGE DRAFT SPECIFICATION FOR SUBMISSION FORMATS V2.0. NOV 13, 2014.
US FDA. DRAFT GUIDANCE. EFFECTIVENESS OF ANTHELMINTICS : SPECIFIC RECOMMENDATIONS FOR THE PREVENTION OF HEARTWORM DISEASE IN DOGS. #276. NOV 2022.
US FDA. DRAFT GUIDANCE. ELECTRONIC SUBMISSION OF EXPEDITED SAFETY REPORTS IND-EXEMPT BA/BE STUDIES. AUG 2022.
US FDA. DRAFT GUIDANCE. ELECTRONIC SYSTEMS, ELECTRONIC RECORDS, AND ELECTRONIC SIGNATURES IN CLINICAL INVESTIGATIONS. QUESTIONS AND ANSWERS. MAR 2023. REV. 1.
US FDA. DRAFT GUIDANCE. ENFORCEMENT POLICY FOR CERTAIN MARKETED TOBACCO PRODUCTS. FEB 2019.
US FDA. DRAFT GUIDANCE. ENHANCED DRUG DISTRIBUTION SECURITY AT THE PACKAGE LEVEL UNDER THE DRUG SUPPLY CHAIN SECURITY ACT. JUN 2021.
US FDA. DRAFT GUIDANCE. ESTABLISHING EFFECTIVENESS AND SAFETY FOR HORMONAL DRUG PRODUCTS INTENDED TO PREVENT PREGNANCY. JUL 2019.
US FDA. DRAFT GUIDANCE. ESTROGEN AND ESTROGEN/PROGESTIN DRUG PRODUCTS TO TREAT VASOMOTOR SYMPTOMS AND VULVAR AND VAGINAL ATROPHY SYMPTOMS — RECOMMENDATIONS FOR CLINICAL EVALUATION. JAN 31, 2003.
US FDA. DRAFT GUIDANCE. ETHICAL CONSIDERATIONS FOR CLINICAL INVESTIGATIONS OF MEDICAL PRODUCTS INVOLVING CHILDREN. SEP 2022.
US FDA. DRAFT GUIDANCE. EVALUATING ALTERNATE CURRICULA FOR THE STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION. JUN 2019.
US FDA. DRAFT GUIDANCE. EVALUATING THE PUBLIC HEALTH IMPORTANCE OF FOOD ALLERGENS OTHER THAN THE MAJOR FOOD ALLERGENS LISTED INTHE FEDERAL FOOD, DRUG, AND COSMETIC ACT. APR 2022.
US FDA. DRAFT GUIDANCE. EVALUATION OF THERAPEUTIC EQUIVALENCE. JUL 2022.
US FDA. DRAFT GUIDANCE. EXPANDED ACCESS TO INVESTIGATIONAL DRUGS FOR TREATMENT USE - QUESTIONS AND ANSWERS. NOV 2022. REV. 1.
US FDA. DRAFT GUIDANCE. FABRY DISEASE : DEVELOPING DRUGS FOR TREATMENT. AUG 2019.
US FDA. DRAFT GUIDANCE. FACILITY READINESS : GOAL DATE DECISIONS UNDER GDUFA. OCT 2022.
US FDA. DRAFT GUIDANCE. FACTORS THAT DISTINUISH LIQUID DIETARY SUPPLEMENTS FROM BEVERAGES, CONSIDERATIONS REGARDING NOVEL INGREDIENTS, AND LABELING FOR BEVERAGES AND OTHER CONVENTIONAL FOODS. DEC 2009.
US FDA. DRAFT GUIDANCE. FDA EXPORT CERTIFICATION. AUG 2021.
US FDA. DRAFT GUIDANCE. FDA NOTIFICATION AND MEDICAL DEVICE REPORTING FOR LABORATORY DEVELOPED TESTS (LDTS). OCT 3, 2014.
US FDA. DRAFT GUIDANCE. FORMAL MEETINGS BETWEEN FDA AND SPONSORS OR REQUESTORS OF OVER-THE-COUNTER MONOGRAPH DRUGS. FEB 2022.
US FDA. DRAFT GUIDANCE. FORMAL MEETINGS BETWEEN THE FDA AND SPONSORS OR APPLICANTS OF PDUFA PRODUCTS. DEC 2017.
US FDA. DRAFT GUIDANCE. FORMAL MEETINGS BETWEEN THE FDA AND SPONSORS OR APPLICATIONS OF BSUFA PRODUCTS. JUN 2018.
US FDA. DRAFT GUIDANCE. FOSTERING MEDICAL DEVICE IMPORVEMENT: FDA ACTIVITIES AND ENGAGEMENT WITH THE VOLUNTARY IMPROVEMENT PROGRAM. MAY 6, 2022.
US FDA. DRAFT GUIDANCE. FRAMEWORK FOR REGULATORY OVERSIGHT OF LABORATORY DEVELOPED TESTS (LDTS). OCT 3, 2014.
US FDA. DRAFT GUIDANCE. FULFILLING REGULATORY REQUIREMENTS FOR POSTMARKETING SUBMISSIONS OF INTERACTIVE PROMOTIONAL MEDIA FOR PRESCRIPTION HUMAN AND ANIMAL DRUGS AND BIOLOGICS. JAN 2014.
US FDA. DRAFT GUIDANCE. GASTROPARESIS : CLINICAL EVALUATION OF DRUGS FOR TREATMENT. AUG 2019. REV. 1.
US FDA. DRAFT GUIDANCE. GENERAL CLINICAL PHARMACOLOGY. CONSIDERATIONS FOR PEDIATRIC STUDIES FOR DRUGS AND BIOLOGICAL PRODUCTS. SEP 2022. REV. 1.
US FDA. DRAFT GUIDANCE. GENERAL CONSIDERATIONS FOR ANIMAL STUDIES FOR MEDICAL DEVICES. OCT 14, 2015.
US FDA. DRAFT GUIDANCE. GERIATRIC INFORMATION IN HUMAN PRESCRIPTION DRUG AND BIOLOGIC PRODUCT LABELING. SEP 2020.
US FDA. DRAFT GUIDANCE. GINGIVITIS: DEVELOPMENT AND EVALUATION OF DRUGS FOR TREATMENT OR PREVENTION. JAN 28, 2005.
US FDA. DRAFT GUIDANCE. GLASS SYRINGES FOR DELIVERING DRUG AND BIOLOGICAL PRODUCTS : TECHNICAL INFORMATION TO SUPPLEMENT INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (ISO) STANDARD 11040-4. APR 2013.
US FDA. DRAFT GUIDANCE. GLUTEN IN DRUG PRODUCTS AND ASSOCIATED LABELING RECOMMENDATIONS. DEC 2017.
US FDA. DRAFT GUIDANCE. GOOD REVIEW MANAGEMENT PRINCIPLES AND PRACTICES FOR NEW DRUG APPLICATIONS AND BIOLOGICS LICENSE APPLICATIONS. SEP 2018. REV. 1.
US FDA. DRAFT GUIDANCE. GOOD REVIEW MANAGEMENT PRINCIPLES AND PRACTICES FOR PDUFA PRODUCTS. APR 01, 2005.
US FDA. DRAFT GUIDANCE. GUIDANCE FOR SUBMITTING HCV RESISTANCE DATA. ATTACHMENT TO GUIDANCE ON ANTIVIRAL PRODUCT DDEVELOPMENT - CONDUCTING AND SUBMITTING VIROLOGY STUDIES TO THE AGENCY. FEB 2013. REV. 1.
US FDA. DRAFT GUIDANCE. GUIDANCE ON ANTIVIRAL PRODUCT DEVELOPMENT - CONDUCTING AND SUBMITTING VIROLOGY STUDIES OT THE AGENCY. GUIDANCE FOR SUBMITTING HIV-1 RESISTANCE DATA. FEB 2014. REV. 1.
US FDA. DRAFT GUIDANCE. GUIDANCE ON EXCULPATORY LANGUAGE IN INFORMED CONSENT. AUG 19, 2011.
US FDA. DRAFT GUIDANCE. GUIDE TO MINIMIZE FOOD SAFETY HAZARDS OF FRESH-CUT PRODUCE. OCT 2018.
US FDA. DRAFT GUIDANCE. HARMONIZING COMPENDIAL STANDARDS WITH DRUG APPLICATION APPROVAL USING THE USP PENDING MONOGRAPH PROCESS. JUL 2019.
US FDA. DRAFT GUIDANCE. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD AND ANIMALS : SUPPLY-CHAIN PROGRAM. #246. JUN 2018.
US FDA. DRAFT GUIDANCE. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD. JAN 2018.
US FDA. DRAFT GUIDANCE. HELICOBACTER PYLORI-ASSOCIATED DUODENAL ULCER DISEASE IN ADULTS : DEVELOPING DRUGS FOR TREATMENT. OCT 2009.
US FDA. DRAFT GUIDANCE. HOSPITAL AND HEALTH SYSTEM COMPOUNDING UNDER SECTION 503A OF THE FEDERAL, FOOD, DRUG, AND COSMETIC ACT. REV. 1. OCT 2021.
US FDA. DRAFT GUIDANCE. HOW TO COMPLY WITH THE PEDIATRIC RESEARCH EQUITY ACT. SEP 07, 2005.
US FDA. DRAFT GUIDANCE. HOW TO OBTAIN A COVERED PRODUCT AUTHORIZATION. SEP 2022.
US FDA. DRAFT GUIDANCE. HUMAN FACTORS STUDIES AND RELATED CLINICAL STUDY CONSIDERATIONS IN COMBINATION PRODUCT DESIGN AND DEVELOPMENT. FEB 2016.
US FDA. DRAFT GUIDANCE. HUMAN FOOD BY-PRODUCTS FOR USE AS ANIMAL FOOD. #239. AUG 2016.
US FDA. DRAFT GUIDANCE. HUMAN GENE THERAPY PRODUCTS INCORPORATING HUMAN GENOME EDITING. MAR 2022.
US FDA. DRAFT GUIDANCE. HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - LABELING FOR DOSING BASED ON WEIGHT OR BODY SURFACE AREA FOR READY-TO-USE CONTAINERS - “DOSE BANDING”. JUL 2022.
US FDA. DRAFT GUIDANCE. HYDROGEN PEROXIDE-BASED CONTACT LENS CARE PRODUCTS : CONSUMER LABELING RECOMMENDATIONS - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. AUG 2022.
US FDA. DRAFT GUIDANCE. HYPERTENSION : CONDUCTING STUDIES OF DRUGS TO TREAT PATIENTS ON A BACKGROUND OF MULTIPLE ANTIHYPERTENSIVE DRUGS. JUL 2018.
US FDA. DRAFT GUIDANCE. ICH Q12: IMPLEMENTATION CONSIDERATIONS FOR FDA-REGULATED PRODUCTS. MAY 2021.
US FDA. DRAFT GUIDANCE. IDENTIFYING TRADING PARTNERS UNDER THE DRUG SUPPLY CHAIN SECURITY ACT. JUL 2022. REV. 1.
US FDA. DRAFT GUIDANCE. IMMUNOGENICITY INFORMATION IN HUMAN PRESCRIPTION THERAPEUTIC PROTEIN AND SELECT DRUG PRODUCT LABELING - CONTENT AND FORMAT. FEB 2022.
US FDA. DRAFT GUIDANCE. IMPURITIES : RESIDUAL SOLVENTS IN NEW VETERINARY MEDICINAL PRODUCTS, ACTIVE SUBSTANCES AND EXCIPIENTS (REVISION). #100. VICH GL18(R2). JUL 2022.
US FDA. DRAFT GUIDANCE. IN VITRO DIAGNOSTIC MULTIVARIATE INDEX ASSAYS. ACCESSED : MAR 24, 2022.
US FDA. DRAFT GUIDANCE. IN VITRO PERMEATION TEST STUDIES FOR TOPICAL DRUG PRODUCTS. OCT 2022.
US FDA. DRAFT GUIDANCE. IN VITRO RELEASE TEST STUDIES FOR TOPICAL DRUG PRODUCTS SUBMITTED IN ANDAS. OCT 2022.
US FDA. DRAFT GUIDANCE. INBORN ERRORS OF METABOLISM THAT USE DIETARY MANAGEMENT : CONSIDERATIONS FOR OPTIMIZING AND STANDARDIZING DIET IN CLINICAL TRIALS FOR DRUG PRODUCT DEVELOPMENT. JUL 2018.
US FDA. DRAFT GUIDANCE. INCLUSION OF OLDER ADULTS IN CANCER CLINICAL TRIALS. MAR 2020.
US FDA. DRAFT GUIDANCE. IND SUBMISSIONS FOR INDIVIDUALIZED ANTISENSE OLIGONUCLEOTIDE DRUG PRODUCTS : ADMINISTRATIVE AND PROCEDURAL RECOMMENDATIONS. JAN 2021.
US FDA. DRAFT GUIDANCE. INDICATIONS AND USAGE SECTION OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. JUL 2018.
US FDA. DRAFT GUIDANCE. INFECTIOUS DISEASE NEXT GENERATION SEQUENCING BASED DIAGNOSTIC DEVICES : MICROBIAL IDENTIFICATION AND DETECTION OF ANTIMICROBIAL RESISTANCE AND VIRULENCE MARKERS. MAY 13, 2016.
US FDA. DRAFT GUIDANCE. INFORMATION SHEET GUIDANCE. FREQUENTLY ASKED QUESTIONS STATEMENT OF INVESTIGATOR (FORM FDA 1572). MAY 2021. REV. 1.
US FDA. DRAFT GUIDANCE. INFORMED CONSENT INFORMATION SHEET. JUL 2014.
US FDA. DRAFT GUIDANCE. INNOVATIVE APPROACHES FOR NONPRESCRIPTION DRUG PRODUCTS. JUL 2018.
US FDA. DRAFT GUIDANCE. INSPECTION OF INJECTABLE PRODUCTS FOR VISIBLE PARTICULATES. DEC 2021.
US FDA. DRAFT GUIDANCE. INTERNET / SOCIAL MEDIA PLATFORMS : CORRECTING INDEPENDENT THIRD-PARTY MISINFORMATION ABOUT PRESCRIPTION DRUGS AND MEDICAL DEVICES. JUN 2014.
US FDA. DRAFT GUIDANCE. INTERNET / SOCIAL MEDIA PLATFORMS WITH CHARACTER SPACE LIMITATIONS - PRESENTING RISK AND BENEFIT INFORMATION FOR PRESCRIPTION DRUGS AND MEDICAL DEVICES. JUN 2014.
US FDA. DRAFT GUIDANCE. INTERSTITIAL CYSTITIS / BLADDER PAIN SYNDROME (IC/BPS) : ESTABLISHING EFFECTIVENESS OF DRUGS FOR TREATMENT. DEC 2019.
US FDA. DRAFT GUIDANCE. INVESTIGATIONAL IVDS USED IN CLINICAL INVESTIGATIONS OF THERAPEUTIC PRODUCTS. DEC 18, 2017.
US FDA. DRAFT GUIDANCE. INVESTIGATIONAL NEW DRUG APPLICATION SUBMISSIONS FOR INDIVIDUALIZED ANTISENSE OLIGONUCLEOTIDE DRUG PRODUCTS FOR SEVERELY DEBILITATING OR LIFE-THREATENING DISEASES : CHEMISTRY, MANUFACTURING, AND CONTROLS RECOMMENDATIONS. DEC 2021.
US FDA. DRAFT GUIDANCE. INVESTIGATIONAL NEW DRUG APPLICATION SUBMISSIONS FOR INDIVIDUALIZED ANTISENSE OLIGONUCLEOTIDE DRUG PRODUCTS FOR SEVERELY DEBILITATING OR LIFE-THREATENING DISEASES : CLINICAL RECOMMENDATIONS. DEC 2021.
US FDA. DRAFT GUIDANCE. INVESTIGATIONAL NEW DRUG APPLICATIONS PREPARED AND SUBMITTED BY SPONSOR-INVESTIGATORS. MAY 2015.
US FDA. DRAFT GUIDANCE. INVESTIGATOR RESPONSIBILITIES - SAFETY REPORTING FOR INVESTIGATIONAL DRUGS AND DEVICES. SEP 2021.
US FDA. DRAFT GUIDANCE. LABELING OF PLANT-BASED MILK ALTERNATIVES AND VOLUNTARY NUTRIENT STATEMENTS. FEB 2023.
US FDA. DRAFT GUIDANCE. LASER-ASSISTED IN SITU KERATOMILEUSIS (LASIK) LASERS - PATIENT LABELING RECOMMENDATIONS. JUL 28, 2022.
US FDA. DRAFT GUIDANCE. LEAD IN COSMETIC LIP PRODUCTS AND EXTERNALLY APPLIED COSMETICS : RECOMMENDED MAXIMUM LEVEL. DEC 2016.
US FDA. DRAFT GUIDANCE. LIST OF HIGHEST PRIORITY DEVICES FOR HUMAN FACTORS REVIEW. FEB 3, 2016.
US FDA. DRAFT GUIDANCE. LOW SEXUAL INTEREST, DESIRE, AND/OR AROUSAL IN WOMEN : DEVELOPING DRUGS FOR TREATMENT. OCT 2016.
US FDA. DRAFT GUIDANCE. M12 DRUG INTERACTION STUDIES. AUG 2022.
US FDA. DRAFT GUIDANCE. M13A BIOEQUIVALENCE FOR IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORMS. JAN 2023.
US FDA. DRAFT GUIDANCE. MAJOR DEPRESSIVE DISORDER : DEVELOPNG DRUGS FOR TREATMENT. JUN 2018. REV. 1.
US FDA. DRAFT GUIDANCE. MATERIAL THREAT MEDICAL COUNTERMEASURE PRIORITY REVIEW VOUCHERS. JAN 2018.
US FDA. DRAFT GUIDANCE. MEASURING GROWTH AND EVALUTING PUBERTAL DEVELOPMENT IN PEDIATRIC CLINICAL TRIALS. NOV 2022.
US FDA. DRAFT GUIDANCE. META-ANALYSES OF RANDOMIZED CONTROLLED CLINICAL TRIALS TO EVALUATE THE SAFETY OF HUMAN DRUGS OR BIOLOGICAL PRODUCTS. NOV 2018.
US FDA. DRAFT GUIDANCE. METERED DOSE INHALER (MDI) AND DRY POWDER INAHLER (DPI) PRODUCTS - QUALITY CONSIDERATIONS. APR 2018. REV. 1.
US FDA. DRAFT GUIDANCE. MICROBIOLOGICAL QUALITY CONSIDERATIONS IN NON-STERILE DRUG MANUFACTURING. SEP 2021.
US FDA. DRAFT GUIDANCE. MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION. MAR 2019.
US FDA. DRAFT GUIDANCE. MODIFIED RISK TOBACCO PRODUCT APPLICATIONS. MAR 2012.
US FDA. DRAFT GUIDANCE. MPOX : DEVELOPMENT OF DRUGS AND BIOLOGICAL PRODUCTS. JAN 2023. [MONKEYPOX]
US FDA. DRAFT GUIDANCE. MUCOPOLYSACCHARIDOSIS TYPE III (SANFILIPPO SYNDROME) : DEVELOPING DRUGS FOR TREATMENT. FEB 2020.
US FDA. DRAFT GUIDANCE. NEOVASCULAR AGE-RELATED MACULAR DEGENERATION : DEVELOPING DRUGS FOR TREATMENT. FEB 2023.
US FDA. DRAFT GUIDANCE. NEW AND REVISED DRAFT Q&AS ON BIOSIMILAR DEVELOPMENT AND THE BPCI ACT (REVISION 3). REV 3. SEP 2021.
US FDA. DRAFT GUIDANCE. NON-CLINICAL AND CLINICAL INVESTIGATION OF DEVICES USED FOR THE TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH). DEC 27, 2021.
US FDA. DRAFT GUIDANCE. NON-CLINICAL PERFORMANCE ASSESSMENT OF TISSUE CONTAINMENT SYSTEMS USED DURING POWER MORCELLATION PROCEDURES. JUN 21, 2022.
US FDA. DRAFT GUIDANCE. NON-PENICILLIN BETA-LACTAM DRUGS : A CGMP FRAMEWORK FOR PREVENTING CROSS-CONTAMINATION. JUN 2022. REV. 1.
US FDA. DRAFT GUIDANCE. NONALCOHOLIC STEATOHEPATITIS WITH COMPENSATED CIRRHOSIS : DEVELOPING DRUGS FOR TREATMENT. JUN 2019.
US FDA. DRAFT GUIDANCE. NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS WITH LIVER FIBROSIS : DEVELOPING DRUGS FOR TREATMENT. DEC 2018.
US FDA. DRAFT GUIDANCE. NONCLINICAL SAFETY EVALUATION OF THE IMMUNOTOXIC POTENTIAL OF DRUGS AND BIOLOGICS. FEB 2020.
US FDA. DRAFT GUIDANCE. NONCLINICAL TESTING OF INDIVIDUALIZED ANTISENSE OLIGONUCLEOTIDE DRUG PRODUCTS FOR SEVERELY DEBILITATING OR LIFE-THREATENING DISEASES. APR 2021.
US FDA. DRAFT GUIDANCE. NONPROPRIETARY NAMING OF BIOLOGICAL PRODUCTS : UPDATE. MAR 2019.
US FDA. DRAFT GUIDANCE. NONTUBERCULOUS MYCOBACTERIAL PULMONARY DISEASE CAUSED BY MYCOBACTERIUM AVIUM COMPLEX : DEVELOPING DRUGS FOR TREATMENT. SEP 2021.
US FDA. DRAFT GUIDANCE. NOTIFYING FDA OF A PERMANENT DISCONTINUANCE OR INTERRUPTION IN MANUFACTURING OF A DEVICE UNDER SECTION 506J OF THE FD&C ACT. JAN 11, 2022.
US FDA. DRAFT GUIDANCE. OPIOID ANALGESIC DRUGS : CONSIDERATIONS FOR BENEFIT-RISK ASSESSMENT FRAMEWORK. JUN 2019.
US FDA. DRAFT GUIDANCE. OPTIMIZING THE DOSAGE OF HUMAN PRESCRIPTION DRUGS AND BIOLOGICAL PRODUCTS FOR THE TREATMENT OF ONCOLOGIC DISEASES. JAN 2023.
US FDA. DRAFT GUIDANCE. ORAL DRUG PRODUCTS ADMINISTERED VIA ENTERAL FEEDING TUBE: IN VITRO TESTING AND LABELING RECOMMENDATIONS. JUN 2021.
US FDA. DRAFT GUIDANCE. OSTEOARTHRITIS : STRUCTURAL ENDPOINTS FOR THE DEVELOPMENT OF DRUGS, DEVICES, AND BIOLOGICAL PRODUCTS FOR TREATMENT. AUG 2018.
US FDA. DRAFT GUIDANCE. PATHOLOGY PEER REVIEW IN NONCLINICAL TOXICOLOGY STUDIES : QUESTIONS AND ANSWERS. DEC 2021.
US FDA. DRAFT GUIDANCE. PATIENT-FOCUSED DRUG DEVELOPMENT : SELECTING, DEVELOPING, OR MODIFYING FIT-FOR-PURPOSE CLINICAL OUTCOME ASSESSMENTS. JUN 2022.
US FDA. DRAFT GUIDANCE. PEDIATRIC GASTROESOPHAGEAL REFLUX DISEASE : DEVELOPING DRUGS FOR TREATMENT. OCT 2017.
US FDA. DRAFT GUIDANCE. PEDIATRIC RARE DISEASES - A COLLABORATIVE APPROACH FOR DRUG DEVELOPMENT USING GAUCHER DISEASE AS A MODEL. DEC 2017.
US FDA. DRAFT GUIDANCE. PERIPHERAL PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) AND SPECIALTY CATHETERS - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. JAN 13, 2020.
US FDA. DRAFT GUIDANCE. PHARMACOGENOMIC DATA SUBMISSIOINS - COMPANION GUIDANCE. AUG 2007.
US FDA. DRAFT GUIDANCE. PHARMACOGENOMIC DATA SUBMISSIONS. MAR 2023.
US FDA. DRAFT GUIDANCE. PHARMACOKINETICS IN PATIENTS WITH IMPAIRED RENAL FUNCTION - STUDY DESIGN, DATA ANALYSIS, AND IMPACT ON DOSING. SEP 2020. REV 2.
US FDA. DRAFT GUIDANCE. PHARMACOKINETICS IN PREGNANCY — STUDY DESIGN, DATA ANALYSIS, AND IMPACT ON DOSING AND LABELING. NOV 01, 2004.
US FDA. DRAFT GUIDANCE. PHOTOBIOMODULATION (PBM) DEVICES - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. JAN 12, 2023.
US FDA. DRAFT GUIDANCE. POLICY REGARDING CERTAIN NEW DIETARY INGREDIENTS AND DIETARY SUPPLEMENTS SUBJECT TO THE REQUIREMENT FOR PRE-MARKET NOTIFICATION. MAY 2022.
US FDA. DRAFT GUIDANCE. POLICY REGARDING QUANTITATIVE LABELING OF DIETARY SUPPLEMENTS CONTAINING LIVE MICROBIALS. SEP 2018.
US FDA. DRAFT GUIDANCE. POSTAPPROVAL CHANGES TO DRUG SUBSTANCES. SEP 2018.
US FDA. DRAFT GUIDANCE. POSTAPPROVAL PREGNANCY SAFETY STUDIES. MAY 2019.
US FDA. DRAFT GUIDANCE. POSTMARKETING SAFETY REPORTING FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS INCLUDING VACCINES: DRAFT GUIDANCE FOR INDUSTRY. MAR 12, 2001.
US FDA. DRAFT GUIDANCE. POSTMARKETING STUDIES AND CLINICAL TRIALS - IMPLEMENTATION OF SECTION 505(O)(3) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. OCT 2019. REV. 1.
US FDA. DRAFT GUIDANCE. POTENCY ASSAY CONSIDERATIONS FOR MONOCLONAL ANTIBODIES AND OTHER THERAPEUTIC PROTEINS TARGETING VIRAL PATHOGENS. MAR 2023.
US FDA. DRAFT GUIDANCE. PREGNANCY, LACTATION, AND REPRODUCTIVE POTENTIAL : LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. JUL 2020.
US FDA. DRAFT GUIDANCE. PRESCRIPTION DRUG USER FEE ACT WAIVERS FOR FIXED-COMBINATION ANTIRETROVIRAL DRUGS FOR THE PRESIDENT’S EMERGENCY PLAN FOR AIDS RELIEF. JUN 2018.
US FDA. DRAFT GUIDANCE. PRESENTING QUANTITATIVE EFFICACY AND RISK INFORMATION IN DIRECT-TO-CONSUMER PROMOTIONAL LABELING AND ADVERTISEMENTS. OCT 2018.
US FDA. DRAFT GUIDANCE. PRESENTING RISK INFORMATION IN PRESCRIPTION DRUG AND MEDICAL DEVICE PROMOTION. MAY 2009.
US FDA. DRAFT GUIDANCE. PRINCIPLES FOR CODEVELOPMENT OF AN IN VITRO COMPANION DIAGNOSTIC DEVICE WITH A THERAPEUTIC PRODUCT. JUL 15, 2016.
US FDA. DRAFT GUIDANCE. PRIOR NOTICE OF IMPORTED FOOD QUESTIONS AND ANSWERS (EDITION 4). SEP 2022.
US FDA. DRAFT GUIDANCE. PROCEDURES FOR EVALUATING APPEARANCE ISSUES AND GRANTING AUTHORIZATIONS FOR PARTICIPATION IN FDA ADVISORY COMMITTEES. JUN 2016.
US FDA. DRAFT GUIDANCE. PRODUCT TITLE AND INITIAL U.S. APPROVAL IN THE HIGHLIGHTS OF PRESCRIBING INFORMATION FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. JAN 2018.
US FDA. DRAFT GUIDANCE. PRODUCT-SPECIFIC GUIDANCE MEETINGS BETWEEN FDA AND ANDA APPLICANTS UNDER GDUFA. FEB 2023.
US FDA. DRAFT GUIDANCE. PROMOTIONAL LABELING AND ADVERTISING CONSIDERATIONS FOR PRESCRIPTION BIOLOGICAL REFERENCE AND BIOSIMILAR PRODUCTS. QUESTIONS AND ANSWERS. FEB 2020.
US FDA. DRAFT GUIDANCE. PROTEIN EFFICIENCY RATIO (PER) RAT BIOASSAY STUDIES TO DEMONSTRATE THAT A NEW INFANT FORMULA SUPPORTS THE QUALITY FACTOR OF SUFFICIENT BIOLOGICAL QUALITY OF PROTEIN. MAR 2023.
US FDA. DRAFT GUIDANCE. PROVIDING OVER-THE-COUNTER MONOGRAPH SUBMISSIONS IN ELECTRONIC FORMAT. SEP 2022.
US FDA. DRAFT GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT : IND SAFETY REPORTS. OCT 2019.
US FDA. DRAFT GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT ORPHAN-DRUG AND HUMANITARIAN USE DEVICE DESIGNATION REQUESTS AND RELATED SUBMISSIONS: DRAFT DRAFT GUIDANCE FOR INDUSTRY. FEB 01, 2006.
US FDA. DRAFT GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC OR PAPER FORMAT TO THE OFFICE OF FOOD ADDITIVE SAFETY. MAR 2010.
US FDA. DRAFT GUIDANCE. PUBLIC AVAILABILITY OF LABELING CHANGES IN "CHANGES BEING EFFECTED" SUPPLEMENTS. SEP 20, 2006.
US FDA. DRAFT GUIDANCE. PULMONARY TUBERCULOSIS : DEVELOPING DRUGS FOR TREATMENT. DEC 2022. REV. 1.
US FDA. DRAFT GUIDANCE. Q14 ANALYTICAL PROCEDURE DEVELOPMENT. AUG 2022.
US FDA. DRAFT GUIDANCE. Q1B PHOTOSTABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS. MAR 07, 1996.
US FDA. DRAFT GUIDANCE. Q2(R2) VALIDATION OF ANALYTICAL PROCEDURES. AUG 2022.
US FDA. DRAFT GUIDANCE. Q3C: APPENDIX 4. MAR 18, 1998.
US FDA. DRAFT GUIDANCE. Q3C: APPENDIX 6. MAR 18, 1998.
US FDA. DRAFT GUIDANCE. Q5A VIRAL SAFETY EVALUATION OF BIOTECHNOLOGY PRODUCTS DERIVED FROM CELL LINES OF HUMAN OR ANIMAL ORIGIN. NOV 14, 2022.
US FDA. DRAFT GUIDANCE. Q9(R1) QUALITY RISK MANAGEMENT. JUN 2022.
US FDA. DRAFT GUIDANCE. QUALIFICATION OF BIOMARKER - GALACTOMANNAN IN STUDIES OF TREATMENTS OFINVASIVE ASPERGILLOSIS. NOV 2015.
US FDA. DRAFT GUIDANCE. QUALITY CONSIDERATIONS FOR CONTINUOUS MANUFACTURING. FEB 2019.
US FDA. DRAFT GUIDANCE. QUANTITATIVE LABELING OF SODIUM, POTASSIUM, AND PHOSPHORUS FOR HUMAN OVER-THE-COUNTER AND PRESCRIPTION DRUG PRODUCTS. SEP 2022.
US FDA. DRAFT GUIDANCE. QUESTIONS AND ANSWERS ABOUT DIETARY GUIDANCE STATEMENTS IN FOOD LABELING. MAR 2023.
US FDA. DRAFT GUIDANCE. QUESTIONS AND ANSWERS REGARDING THE REPORTABLE FOOD REGISTRATION AS ESTABLISHED BY THE FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007 (EDITION 2). MAY 2010.
US FDA. DRAFT GUIDANCE. RABIES : DEVELOPING MONOCLONAL ANTIBODY COCKTAILS FOR THE PASSIVE IMMUNIZATION COMPONENT OF POST-EXPOSURE PROPHYLAXIS. JUL 2021.
US FDA. DRAFT GUIDANCE. RARE DISEASES : COMMON ISSUES IN DRUG DEVELOPMENT. JAN 2019. REV. 1.
US FDA. DRAFT GUIDANCE. RARE DISEASES : EARLY DRUG DEVELOPMENT AND THE ROLE OF PRE-IND MEETINGS. OCT 2018.
US FDA. DRAFT GUIDANCE. RARE DISEASES : NATURAL HISTORY STUDIES FOR DRUG DEVELOPMENT. MAR 2019.
US FDA. DRAFT GUIDANCE. RARE PEDIATRIC DISEASE PRIORITY REVIEW VOUCHERS. JUL 2019.
US FDA. DRAFT GUIDANCE. REAL-TIME ONCOLOGY REVIEW (RTOR). JUL 2022.
US FDA. DRAFT GUIDANCE. REAL-WORLD DATA: ASSESSING ELECTRONIC HEALTH RECORDS AND MEDICAL CLAIMS DATA TO SUPPORT REGULATORY DECISION-MAKING FOR DRUG AND BIOLOGICAL PRODUCTS. SEP 2021.
US FDA. DRAFT GUIDANCE. REAL-WORLD DATA: ASSESSING REGISTRIES TO SUPPORT REGULATORY DECISION-MAKING FOR DRUG AND BIOLOGICAL PRODUCTS. NOV 2021.
US FDA. DRAFT GUIDANCE. RECOMMENDATIONS FOR EVALUATING DONOR ELIGIBILITY USING INDIVIDUAL RISK-BASED QUESTIONS TO REDUCE THE RISK OF HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION BY BLOOD AND BLOOD PRODUCTS. JAN 2023.
US FDA. DRAFT GUIDANCE. REFERENCE PRODUCT EXCLUSIVITY FOR BIOLOGICAL PRODUCTS FILED UNDER SECTION 351(A) OF THE PHS ACT. AUG 2014.
US FDA. DRAFT GUIDANCE. REFUSE TO FILE : NDA AND BLA SUBMISSIONS TO CDER. DEC 2017.
US FDA. DRAFT GUIDANCE. REGULATION OF INTENTIONALLY ALTERED GENOMIC DNA IN ANIMALS. JAN 2017.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART II COMMON ELEMENTS. MAR 2010.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART III ELECTRONIC FORMAT. DEC 2013.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART IV FOOD OR COLOR ADDITIVE SUBMISSIONS. MAR 2010.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART IX FDA REFERENCES. MAR 2010.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART V FOOD CONTACT SUBSSTANCE SUBMISSIONS. MAR 2010.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART VI GRAS NOTICES. MAR 2010.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART VII BIOTECHNOLOGY FINAL CONSULTATIONS. MAR 2010.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART VIII NEW PROTEIN CONSULTATIONS. MAR 2010.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, PART X APPENDICES. MAR 2010.
US FDA. DRAFT GUIDANCE. REGULATORY SUBMISSIONS TO OFAS, QUICK LINKS. MAR 2010.
US FDA. DRAFT GUIDANCE. REMANUFACTURING OF MEDICAL DEVICES. JUN 24, 2021.
US FDA. DRAFT GUIDANCE. REMS ASSESSMENT : PLANNING AND REPORTING. JAN 2019.
US FDA. DRAFT GUIDANCE. REPLACEMENT REAGENT AND INSTRUMENT FAMILY POLICY FOR IN VITRO DIAGNOSTIC DEVICES. DEC 18, 2017.
US FDA. DRAFT GUIDANCE. REPORTING AMOUNT OF LISTED DRUGS AND BIOLOGICAL PRODUCTS UNDER SECTION 510(J)(3) OF THE FD&C ACT. OCT 2021.
US FDA. DRAFT GUIDANCE. REPORTING DRUG SAMPLE INFORMATION UNDER SECTION 6004 OF THE AFFORDABLE CARE ACT. JUL 2014.
US FDA. DRAFT GUIDANCE. REPORTING HARMFUL AND POTENTIALLY HARMFUL CONSTITUENTS IN TOBACCO PRODUCTS AND TOBACCO SMOKE UNDER SECTION 904(A)(3) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. MAR 2012.
US FDA. DRAFT GUIDANCE. REQUESTS FOR RECONSIDERATION AT THE DIVISION LEVEL UNDER GDUFA. OCT 2017.
US FDA. DRAFT GUIDANCE. RESPIRATORY SYNCYTIAL VIRUS INFECTION : DEVELOPING ANTIVIRAL DRUGS FOR PROPHYLAXIS AND TREATMENT. OCT 2017.
US FDA. DRAFT GUIDANCE. RESPONDING TO UNSOLICITED REQUESTS FOR OFF-LABEL INFORMATION ABOUT PRESCRIPTION DRUGS AND MEDICAL DEVICES. DEC 2011.
US FDA. DRAFT GUIDANCE. RESTRICTED DELIVERY SYSTEMS : FLOW RESTRICTORS FOR ORAL LIQUID DRUG PRODUCTS. MAR 2020.
US FDA. DRAFT GUIDANCE. REVIEW OF DRUG MASTER FILES IN ADVANCE OF CERTAIN ANDA SUBMISSIONS UNDER GDUFA. OCT 2022.
US FDA. DRAFT GUIDANCE. REVISING ANDA LABELING FOLLOWING REVISION OF THE RLD LABELING. REV. 1. JAN 2022.
US FDA. DRAFT GUIDANCE. RHEUMATOID ARTHRITIS : DEVELOPING DRUG PRODUCTS FOR TREATMENT. MAY 2013. REV. 1.
US FDA. DRAFT GUIDANCE. RISK MANAGEMENT PLANS TO MITIGATE THE POTENTIAL FOR DRUG SHORTAGES. MAY 2022.
US FDA. DRAFT GUIDANCE. S12 NONCLINICAL BIODISTRIBUTION CONSIDERATIONS FOR GENE THERAPY PRODUCTS. JUN 3, 2021.
US FDA. DRAFT GUIDANCE. SAMENESS EVALUATIONS IN AN ANDA - ACTIVE INGREDIENTS. NOV 2022.
US FDA. DRAFT GUIDANCE. SCIENTIFIC AND ETHICAL CONSIDERATIONS FOR INCLUSION IN CLINICAL TRIALS. APR 2018. REV. 1.
US FDA. DRAFT GUIDANCE. SELECT UPDATES FOR BIOCOMPATIBILITY OF CERTAIN DEVICES IN CONTACT WITH INTACT SKIN. OCT 15, 2020.
US FDA. DRAFT GUIDANCE. SELECT UPDATES FOR THE BREAKTHROUGH DEVICES PROGRAM GUIDANCE : REDUCING DISPARITIES IN HEALTH AND HEALTH CARE. OCT 21, 2022.
US FDA. DRAFT GUIDANCE. SELECT UPDATES FOR UNIQUE DEVICE IDENTIFICATION: POLICY REGARDING GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE REQUIREMENTS FOR CERTAIN DEVICES. OCT 14, 2021.
US FDA. DRAFT GUIDANCE. SETTING ENDOTOXIN LIMITS DURING DEVELOPMENT OF INVESTIGATIONAL ONCOLOGY DRUGS AND BIOLOGICAL PRODUCTS. JUL 2020.
US FDA. DRAFT GUIDANCE. SMOKING CESSATION AND RELATED INDICATIONS : DEVELOPING NICOTINE REPLACEMENT THERAPY DRUG PRODUCTS. FEB 2019.
US FDA. DRAFT GUIDANCE. SOFT (HYDROPHILIC DAILY WEAR CONTACT LENSES - PERFORMANCE CRITERIA FOR SAFETY AND PERFORMANCE BASED PATHWAY. MAR 4, 2020.
US FDA. DRAFT GUIDANCE. SPECIAL CONSIDERATIONS, INCENTIVES, AND PROGRAMS TO SUPPORT THE APPROVAL OF NEW ANIMAL DRUGS FOR MINOR USES AND FOR MINOR SPECIES. #61. JUL 2020.
US FDA. DRAFT GUIDANCE. SPL STANDARD FOR CONTENT OF LABELING TECHNICAL QS & AS. OCT 2009. REV. 1.
US FDA. DRAFT GUIDANCE. SPONSOR RESPONSIBILITIES - SAFETY REPORTING REQUIREMENTS AND SAFETY ASSESSMENT FOR IND AND BIOAVAILABILITY / BIOEQUIVALENCE STUDIES. JUN 2021.
US FDA. DRAFT GUIDANCE. STANDARDIZATION OF DATA AND DOCUMENTATION PRACTICES FOR PRODUCT TRACING. MAR 2018.
US FDA. DRAFT GUIDANCE. STANDARDIZED FORMAT FOR ELECTRONIC SUBMISSION OF NDA AND BLA CONTENT FOR THE PLANNING OF BIORESEARCH MONITORING (BIMO) INSPECTIONS FOR CDER SUBMISSIONS. FEB 2018.
US FDA. DRAFT GUIDANCE. STANDARDIZED MEDICATED FEED ASSAY LIMITS. #264. FEB 2020.
US FDA. DRAFT GUIDANCE. STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION. OCT 2018.
US FDA. DRAFT GUIDANCE. STATEMENT OF IDENTITY AND STRENGTH - CONTENT AND FORMAT OF LABELING FOR HUMAN NONPRESCRIPTION DRUG PRODUCTS. SEP 2022.
US FDA. DRAFT GUIDANCE. STATISTICAL APPROACHES TO ESTABLISHING BIOEQUIVALENCE. NOV 2022.
US FDA. DRAFT GUIDANCE. STATISTICAL ASPECTS OF THE DESIGN, ANALYSIS, AND INTERPRETATION OF CHRONIC RODENT CARCINOGENICITY STUDIES OF PHARMACEUTICALS. MAY 08, 2001.
US FDA. DRAFT GUIDANCE. STATISTICAL INFORMATION FROM THE JUNE 1999 DRAFT GUIDANCE AND STATISTICAL INFORMATION FOR IN VITRO BIOEQUIVALENCE DATA POSTED ON AUGUST 18, 1999. APR 11, 2003.
US FDA. DRAFT GUIDANCE. SUBMISSION OF QUALITY METRICS DATA. NOV 2016.
US FDA. DRAFT GUIDANCE. SUBMISSION OF WARNING PLANS FOR CIGARETTES AND SMOKELESS TOBACCO PRODUCTS. SEP 2011.
US FDA. DRAFT GUIDANCE. SUBMITTING DEBARMENT CERTIFICATION STATEMENTS. OCT 02, 1998.
US FDA. DRAFT GUIDANCE. SUBMITTING MARKETING APPLICATIONS ACCORDING TO THE ICH/CTD FORMAT: GENERAL CONSIDERATIONS 2001. SEP 05, 2001.
US FDA. DRAFT GUIDANCE. SUBMITTING MARKETING APPLICATIONS ACCORDING TO THE ICH/CTD FORMAT: GENERAL CONSIDERATIONS. SEP 01, 2001.
US FDA. DRAFT GUIDANCE. SUBSTANTIATION FOR STRUCTURE / FUNCTION CLAIMS MADE IN INFANT FORMULA LABELS AND LABELING. SEP 2016.
US FDA. DRAFT GUIDANCE. SUICIDAL IDEATION AND BEHAVIOR : PROSPECTIVE ASSESSMENT OF OCCURRENCE IN CLINICAL TRIALS. AUG 2012. REV. 1.
US FDA. DRAFT GUIDANCE. SUPPLEMENTAL QUESTIONS AND ANSWERS REGARDING FOOD FACILITY REGISTRATION. AUG 2018.
US FDA. DRAFT GUIDANCE. SURVEY METHODOLOGIES TO ASSESS REMS GOALS THAT RELATE TO KNOWLEDGE. JAN 2019.
US FDA. DRAFT GUIDANCE. TECHNICAL CONSIDERATIONS FOR DEMONSTRATING RELIABILITY OF EMERGENCY-USE INJECTORS SUBMITTED UNDER A BLA, NDA, OR ANDA. APR 2020.
US FDA. DRAFT GUIDANCE. TECHNICAL CONSIDERATIONS FOR MEDICAL DEVICES WITH PHYSIOLOGIC CLOSED-LOOP CONTROL TECHNOLOGY. DEC 23, 2021.
US FDA. DRAFT GUIDANCE. THE ACCREDITED THIRD-PARTY CERTIFICATION PROGRAM : QUESTIONS AND ANSWERS. APR 2022.
US FDA. DRAFT GUIDANCE. THE SCOPE OF THE PROHIBITION AGAINST MARKETING A TOBACCO PRODUCT IN COMBINATION WITH ANOHTER ARTICLE OR PRODUCT REGULATED UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. SEP 30, 2009.
US FDA. DRAFT GUIDANCE. THE USE OF PHYSIOLOGICALLY BASED PHARMACOKINETIC ANALYSES - BIOPHARMACEUTICS APPLICATIONS FOR ORAL DRUG PRODUCT DEVELOPMENT, MANUFACTURING CHANGES, AND CONTROLS. OCT 2020.
US FDA. DRAFT GUIDANCE. TISSUE AGNOSTIC DRUG DEVELOPMENT IN ONCOLOGY. OCT 2022.
US FDA. DRAFT GUIDANCE. TOBACCO PRODUCT USER FEES : RESPONSES TO FREQUENTLY ASKED QUESTIONS. MAY 2021.
US FDA. DRAFT GUIDANCE. TOPICAL DERMATOLOGIC CORTICOSTEROIDS: IN VIVO BIOEQUIVALENCE. OCT 2022. REV. 1.
US FDA. DRAFT GUIDANCE. TRANSDERMAL AND TOPICAL DELIVERY SYSTEMS - PRODUCT DEVELOPMENT AND QUALITY CONSIDERATIONS. NOV 2019.
US FDA. DRAFT GUIDANCE. TREATMENT FOR HEART FAILURE : ENDPOINTS FOR DRUG DEVELOPMENT. JUN 2019.
US FDA. DRAFT GUIDANCE. TYPE 2 DIABETES MELLITUS : EVALUATING THE SAFETY OF NEW DRUGS FOR IMPROVING GLYCEMIC CONTROL. MAR 2020.
US FDA. DRAFT GUIDANCE. TYPE V DMFS FOR CDER-LED COMBINATION PRODUCTS USING DEVICE CONSTITUENT PARTS WITH ELECTRONICS OR SOFTWARE. OCT 2019.
US FDA. DRAFT GUIDANCE. ULCERATIVE COLITIS : CLINICAL TRIAL ENDPOINTS. AUG 2016.
US FDA. DRAFT GUIDANCE. ULCERATIVE COLITIS : DEVELOPING DRUGS FOR TREATMENT. APR 2022.
US FDA. DRAFT GUIDANCE. UPDATING ANDA LABELING AFTER THE MARKETING APPLICATION FOR THE REFERENC ELISTED DRUG HAS BEEN WITHDRAWN. JUL 2016.
US FDA. DRAFT GUIDANCE. UPPER FACIAL LINES : DEVELOPING BOTULINUM TOXIN DRUG PRODUCTS. AUG 2014.
US FDA. DRAFT GUIDANCE. USE OF A DRUG MASTER FILE FOR SHARED SYSTEM REMS SUBMISSIONS. NOV 2017.
US FDA. DRAFT GUIDANCE. USE OF CIRCULATING TUMOR DNA FOR EARLY-STAGE SOLID TUMOR DRUG DEVELOPMENT. MAY 2022.
US FDA. DRAFT GUIDANCE. USE OF INVESTIGATIONAL TOBACCO PRODUCTS. FEB 2019.
US FDA. DRAFT GUIDANCE. USE OF LIQUIDS AND/OR SOFT FOODS AS VEHICLES FOR DRUG ADMINISTRATION : GENERAL CONSIDERATIONS FOR SELECTION AND IN VITRO METHODS FOR PRODUCT QUALITY ASSESSMENTS. JUL 2018.
US FDA. DRAFT GUIDANCE. USE OF WHOLE SLIDE IMAGING IN NONCLINICAL TOXICOLOGY STUDIES : QUESTIONS AND ANSWERS. APR 2022.
US FDA. DRAFT GUIDANCE. USING THE INACTIVE INGREDIENT DATABASE. JUL 2019.
US FDA. DRAFT GUIDANCE. VALIDATION AND VERIFICATION OF ANALYTICAL TESTING METHODS USED FOR TOBACCO PRODUCTS. DEC 2021.
US FDA. DRAFT GUIDANCE. VERIFICATION SYSTEMS UNDER THE DRUG SUPPLY CHAIN SECURITY ACT FOR CERTAIN PRESCRIPTION DRUGS. OCT 2018.
US FDA. DRAFT GUIDANCE. VETERINARY FEED DIRECTIVE REGULATION. QUESTIONS AND ANSWERS (REVISED). SMALL ENTITY COMPLIANCE GUIDE. #120. MAR 2019.
US FDA. DRAFT GUIDANCE. VOLUNTARY CONSENSUS STANDARDS RECOGNITION PROGRAM FOR REGENERATIVE MEDICINE THERAPIES. JUN 2022.
US FDA. DRAFT GUIDANCE. VOLUNTARY DISCLOSURE OF SESAME AS AN ALLERGEN. NOV 2020.
US FDA. DRAFT GUIDANCE. VOLUNTARY LABELING INDICATING WHETHER FOOD HAS OR HAS NOT BEEN DERIVED FROM GENETICALLY ENGINEERED ATLANTIC SALMON. REVISED. MAR 2019.
US FDA. DRAFT GUIDANCE. VOLUNTARY MALFUNCTION SUMMARY REPORTING (VMSR) PROGRAM FOR MANUFACTURERS. DEC 2022.
US FDA. DRAFT GUIDANCE. WAIVERS, EXCEPTIONS, AND EXEMPTIONS FROM THE REQUIREMENTS OF SECTION 582 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. MAY 2018.
US FDA. DRAFT GUIDANCE. WHOLE GRAIN LABEL STATEMENTS. FEB 17, 2006.
US FDA. DRAFT GUIDANCES. ACTION LEELS FOR LEAD IN JUICE. APR 2022.
US FDA. DRAFT GUIDELINE. M11 CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP). SEP 27, 2022.
US FDA. DRAFT GUIDELINE. M11 TECHNICAL SPECIFICATION. CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP). SEP 27, 2022.
US FDA. DRAFT GUIDELINE. M11 TEMPLATE. CLINICAL ELECTRONIC STRUCTURED HARMONISED PROTOCOL (CESHARP). SEP 27, 2022.
US FDA. DRUG AND BIOLOGICS SAFETY SURVEILLANCE BEST PRACTICE STATEMENT. ACCESSED : OCT 27, 2022.
US FDA. DRUG ESTABLISHMENTS CURRENT REGISTRATION SITE (WEBPAGE). ACCESSED : MAR 23, 2022.
US FDA. DRUG SAFETY COMMUNICATIONS. ACCESSED : JUN 22, 2022.
US FDA. DRUG SAFETY-RELATED LABELING CHANGES (SRLC) DATABASE OVERVIEW : UPDATES TO SAFETY INFORMATION IN FDA-APPROVED PRESCRIPTION DRUG LABELING. ACCESSED : MAR 23, 2022.
US FDA. DRUGS@FDA. MACITENTAN. ACCESSED : NOV 12, 2021.
US FDA. E19 A SELECTIVE APPROACH TO SAFETY DATA COLLECTION IN SPECIFIC LATE-STAGE PRE-APPROVAL OR POST-APPROVAL CLINICAL TRIALS. DEC 2022.
US FDA. ELECTRONIC COMMON TECHNICAL DOCUMENT (ECTD). ACCESSED : OCT 1, 2021.
US FDA. ELECTRONIC SUBMISSION OF IND SAFETY REPORTS. TECHNICAL CONFORMANCE GUIDE. APR 2022.
US FDA. EMERGENCY USE AUTHORIZATION OF MEDICAL PRODUCTS AND RELATED AUTHORITIES. JAN 2017.
US FDA. EMERGENCY USE AUTHORIZATION. ACCESSED : DEC 22, 2021.
US FDA. FACTORS TO CONSIDER REGARDING BENEFIT-RISK IN MEDICAL DEVICE PRODUCT AVAILABILITY, COMPLIANCE, AND ENFORCEMENT DECISIONS. DEC 27, 2016.
US FDA. FDA APPROVAL OF LYMPHOMA MEDICINE UKONIQ (UMBRALISIB) IS WITHDRAWN DUE TO SAFETY CONCERNS. JUN 1, 2022.
US FDA. FDA DRUG SHORTAGES FREQUENTLY ASKED QUESTIONS. ACCESSED : MAR 23, 2022.
US FDA. FDA FORM 483 FREQUENTLY ASKED QUESTIONS. ACCESSED : JAN 3, 2022.
US FDA. FDA INVESTIGATION OF CRONOBACTER INFECTIONS : POWDERED INFANT FORMULA. (FEBURARY 2022). ACCESSED : MAY 17, 2022.
US FDA. FDA REGIONAL IMPLEMENTATION GUIDE FOR E2B(R3) ELECTRONIC TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS FOR DRUGS AND BIOLOGICAL PRODUCTS. TECHNICAL SPECIFICATIONS DOCUMENT. AUG 2022.
US FDA. FDA’S LABELING RESOURCES FOR HUMAN PRESCRIPTION DRUGS. ACCESSED : JUN 7, 2022.
US FDA. FDA’S POLICY ON DECLARING SMALL AMOUNTS OF NUTRIENTS AND DIETARY INGREDIENTS ON NUTRITION LABELS. JUL 2016.
US FDA. FDA’S SENTINEL INITIATIVE. OCT 18, 2019.
US FDA. FEDERAL FOOD, DRUG, AND COSMETIC ACT (FD&C ACT). ACCESSED : JAN 3, 2022.
US FDA. FINAL GUIDANCE. HAZARD ANALYSIS AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS. #245. JUL 2022.
US FDA. FREEDOM OF INFORMATION. ACCESSED : MAR 23, 2022.
US FDA. FREQUENTLY ASKED QUESTIONS - IRB REGISTRATION. JUL 2009.
US FDA. FSMA FINAL RULE FOR MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION. ACCESSED : MAR 23, 2022.
US FDA. GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID). ACCESSED : MAR 23, 2022.
US FDA. GRAPEFRUIT JUICE AND SOME DRUGS DON’T MIX. JUL 1, 2021.
US FDA. GUIANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 4C(R1) MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS : ACCEPTANCE CRITERIA FOR PHARMACEUTICAL PREPARATIONS AND SUBSTANCES FOR PHARMACEUTICAL USE GENERAL CHAPTER. SEP 2017. REV. 1.
US FDA. GUIDANCE CLINICAL PHARMACOLOGY OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. DEC 2016.
US FDA. GUIDANCE FOR THE PUBLIC, FDA ADVISORY COMMITTEE MEMBERS, AND FDA STAFF : PUBLIC AVAILABILITY OF ADVISORY COMMITTEE MEMBERS’ FINANCIAL INTEREST INFORMATION AND WAIVERS. MAR 2014.
US FDA. GUIDANCE MODIFICATIONS TO DEVICES SUBJECT TO PREMARKET APPROVAL (PMA) - THE PMA SUPPLEMENT DECISION-MAKING PROCESS. DEC 11, 2008.
US FDA. GUIDANCE REDBOOK 2000 : IV.B.3. PATHOLOGY CONSIDERATIONS IN TOXICITY STUDIES. APR 2007.
US FDA. GUIDANCE. "OFF-LABEL" AND INVESTIGATIONAL USE OF MARKETED DRUGS, BIOLOGICS, AND MEDICAL DEVICES. JAN 01, 1998.
US FDA. GUIDANCE. “COMPUTER CROSSMATCH” (COMPUTERIZED ANALYSIS OF THE COMPATABILITY BETWEEN THE DONOR’S CCELL TYPE AND TEH RECIPIENT’S SERUM OR PLASMA TYPE). APR 2011.
US FDA. GUIDANCE. “HARMFUL AND POTENTIALLY HARMFUL CONSTITUENTS” IN TOBACCO PRDOUCTS AS USED IN SECTION 904(E) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (REVISED)*. AUG 2016.
US FDA. GUIDANCE. “LOOKBACK” FOR HEPATITIS C VIRUS (HCV) : PRODUCT QUARANTINE, CONSIGNEE NOTIFICATION, FURTHER TESTING, PRODCUT DISPOSITION, AND NOTIFICATION OF TRANSFUSION RECIPIENTS BASED ON DONOR TEST RESULT INDICATING INFECTION WITH HCV. DEC 2010.
US FDA. GUIDANCE. (POTASSIUM IODIDE) KI IN RADIATION EMERGENCIES-QUESTIONS AND ANSWERS. DEC 23, 2002.
US FDA. GUIDANCE. 1-CONSOLIDATED ANNUAL REPORT FOR A DEVICE PRODUCT LINE (1-CARD). PILLOT FOR PREPARATION OF ANNUAL REPORTS FOR PACEMAKER PREMARKET APPROVAL APPLICATIONS. JUL 06, 2000.
US FDA. GUIDANCE. 180-DAY EXCLUSIVITY : QUESTIONS AND ANSWERS. JAN 2017.
US FDA. GUIDANCE. 180-DAY EXCLUSIVITY WHEN MULTIPLE ANDAS ARE SUBMITTED ON THE SAME DAY. JUL 01, 2003.
US FDA. GUIDANCE. 180-DAY GENERIC DRUG EXCLUSIVITY UNDER THE HATCH-WAXMAN AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. JUN 01, 1998.
US FDA. GUIDANCE. 1991 LETTER TO SEAFOOD MANUFACTURERS REGARDING THE FRAUDULENT PRACTICE OF INCLUDING GLAZE (ICE) AS PART OF THE WEIGHT OF FROZEN SEAFOOD. FEB 2009.
US FDA. GUIDANCE. 2016 MEDICAL GAS CONTAINER - CLOSURE RULE. QUESTIONS AND ANSWERS. SMALL ENTITY COMPLIANCE GUIDE. JAN 2017.
US FDA. GUIDANCE. 30-DAY NOTICES, 135-DAY PREMARKET APPROVAL 9PMA) SUPPLEMENTS AND 75-DAY HUMANITARIAN DEVICE EXEMPTION (HDE) SUPPLEMENTS FOR MANUFACTUROIN METHOD OR PROCESS CHANGES. DEC 16, 2019.
US FDA. GUIDANCE. 510(K) CHECKLIST FOR STERILE LUBRICATING JELLY USED WITH TRANSURETHRAL SURGICAL INSTRUMENTS. SEP 18, 1994.
US FDA. GUIDANCE. 510(K) INFORMATION NEEDED FOR HYDROXYAPATITE COATED ORTHOPEDIC IMPLANTS. FEB 19, 1997.
US FDA. GUIDANCE. 510(K) THIRD PARTY REVIEW PROGRAM. MAR 12, 2020.
US FDA. GUIDANCE. 590.600 WIGS COMPLIANCE POLICY GUIDE 7128.05. .
US FDA. GUIDANCE. A FOOD LABELING GUIDE. JAN 2013.
US FDA. GUIDANCE. A GUIDE FOR THE SUBMISSION OF AN ABBREVIATED RADIATION SAFETY REPORTS ON CEPHALOMETRIC DEVICES INTENDED FOR DIAGNOSTIC USE. FEB 29, 1996.
US FDA. GUIDANCE. A GUIDE FOR THE SUBMISSION OF AN ABBREVIATED REPORT ON X-RAY TABLES, CRADLES, FILM CHANGERS OR CASSETTE HOLDERS INTENDED FOR DIAGNOSTIC USE. MAR 01, 1996.
US FDA. GUIDANCE. A GUIDE TO INFORMED CONSENT. JAN 01, 1998.
US FDA. GUIDANCE. A LABELING GUIDE FOR RESTAURANTS AND RETAIL ESTABLISHMENTS SELLING AWAY-FROM-HOME FOODS - PART II (MENU LABELING REQUIREMENTS IN ACCORDANCE WITH 21 CFR 101.11). APR 2016.
US FDA. GUIDANCE. ABUSE-DETERRENT OPIOIDS - EVALUATION AND LABELING. APR 2015.
US FDA. GUIDANCE. ACCEPTABILITY OF DRAFT LABELING TO SUPPORT ANDA APPROVAL. OCT 2015.
US FDA. GUIDANCE. ACCEPTABLE MEDIA FOR ELECTRONIC PRODUCT USER MANUALS. MAR 18, 2010.
US FDA. GUIDANCE. ACCEPTANCE AND FILING REVIEWS FOR PREMARKET APPROVAL APPLICATIONS (PMAS). DEC 16, 2019.
US FDA. GUIDANCE. ACCEPTANCE OF CLINICAL DATA TO SUPPORT MEDICAL DEVICE APPLICATIONS AND SUBMISSIONS. FREQUENTLY ASKED QUESTIONS. FEB 21, 2018.
US FDA. GUIDANCE. ACCEPTANCE REVIEW FOR DE NOVO CLASSIFICATION REQUESTS. SEP 9, 2019.
US FDA. GUIDANCE. ACCIDENTAL RADIOACTIVE CONTAMINATION OF HUMAN FOOD AND ANIMAL FEEDS: RECOMMENDATIONS FOR STATE AND LOCAL AGENCIES. AUG 13, 1998.
US FDA. GUIDANCE. ACNE VULGARIS : ESTABLISHING EFFECTIVENESS OF DRUGS INTENDED FOR TREATMENT. MAY 2018.
US FDA. GUIDANCE. ACRYLAMIDE IN FOODS. MAR 2016.
US FDA. GUIDANCE. ACTION LEVELS FOR POISONOUS OR DELETERIOUS SUBSTANCES IN HUMAN FOOD AND ANIMAL FEED. JUL 31, 2000.
US FDA. GUIDANCE. ACTIVE CONTROLS IN STUDIES TO DEMONSTRATE EFFECTIVENESS OF A NEW ANIMAL DRUG FOR USE IN COMPANION ANIMALS. DEC 2015.
US FDA. GUIDANCE. ACUTE BACTERIAL EXACERBATIONS OF CHRONIC BRONCHITIS IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE : DEVELOPING ANTIMICROBIAL DRUGS FOR TREATMENT. SEP 2012.
US FDA. GUIDANCE. ACUTE BACTERIAL OTITIS MEDIA : DEVELOPING DRUGS FOR TREATMENT. SEP 2012.
US FDA. GUIDANCE. ACUTE BACTERIAL SINUSITIS : DEVELOPING DRUGS FOR TREATMENT. OCT 2012.
US FDA. GUIDANCE. ACUTE BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS : DEVELOPING DRUGS FOR TREATMENT. OCT 2013.
US FDA. GUIDANCE. ACUTE MYELOID LEUKEMIA : DEVELOPING DRUGS AND BIOLOGICAL PRODUCTS FOR TREATMENT. OCT 2022.
US FDA. GUIDANCE. ADAPTIVE AND OTHER INNOVATIVE DESIGNS FOR EFFECTIVENESS STUDIES OF NEW ANIMAL DRUGS. #268. OCT 2021.
US FDA. GUIDANCE. ADAPTIVE DESIGNS FOR CLINICAL TRIALS OF DRUGS AND BIOLOGICS. NOV 2019.
US FDA. GUIDANCE. ADAPTIVE DESIGNS FOR MEDICAL DEVICE CLINICAL STUDIES. JUL 27, 2016.
US FDA. GUIDANCE. ADDENDUM TO: GUIDANCE ON PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR STERILIZERS INTENDED FOR USE IN HEALTH CARE FACILITIES. SEP 18, 1995.
US FDA. GUIDANCE. ADDITION OF URLS TO ELECTRONIC PRODUCT LABELING . SEP 30, 2010.
US FDA. GUIDANCE. ADDITIONAL RECOMMENDATIONS FOR DONOR SCREENING WITH A LICENSED TEST FOR HIV-1 ANTIGEN:MEMORANDUM TO REGISTERED BLOOD AND PLASMA ESTABLISHMENTS. MAR 14, 1996.
US FDA. GUIDANCE. ADDITIONAL RECOMMENDATIONS FOR TESTING WHOLE BLOOD, BLOOD COMPONENTS, SOURCE PLASMA AND SOURCE LEUKOCYTES FOR ANTIBODY TO HEPATITIS C VIRUS ENCODED ANTIGEN (ANTI-HCV):MEMORANDUM TO REGISTERED BLOOD AND PLASMA ESTABLISHMENTS. MAY 16, 1996.
US FDA. GUIDANCE. ADEQUATE AND APPROPRIATE DONOR SCREENING TESTS FOR HEPATITIS B, HEPATITIS B SURFACE ANTIGEN (HBSAG) ASSAYS USED TO TEST DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA AND SOURCE LEUKOCYTES. NOV 2007.
US FDA. GUIDANCE. ADMINISTRATIVE APPLICATIONS AND THE PHASED REVIEW PROCESS. #132. MAY 2018.
US FDA. GUIDANCE. ADMINISTRATIVE PROCEDURES FOR CLIA CATEGORIZATION. OCT 2, 2017.
US FDA. GUIDANCE. ADVANCED PROSTATE CANCER : DEVELOPING GONADOTROPIN-RELEASING HORMONE ANALOGUES. MAY 2022.
US FDA. GUIDANCE. ADVANCEMENT OF EMERGING TECHNOLOGY APPLICATIONS FOR PHARMACEUTICAL INNOVATION AND MODERNIZATION. SEP 2017.
US FDA. GUIDANCE. ADVERSE EVENT REPORTING FOR OUTSOURCING FACILITIES UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. OCT 2015.
US FDA. GUIDANCE. ADVERSE EVENT REPORTING TO IRBS - IMPROVING HUMAN SUBJECT PROTECTION. JAN 2009.
US FDA. GUIDANCE. ADVERSE REACTIONS SECTION OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS — CONTENT AND FORMAT. JAN 24, 2006.
US FDA. GUIDANCE. ADVISORY COMMITTEE MEETINGS - PREPARATION AND PUBLIC AVAILABILITY OF INFORMATION GIVEN TO ADVISORY COMMITTEE MEMBERS. AUG 2008.
US FDA. GUIDANCE. ADVISORY LEVELS FOR DEOXYNIVALENOL (DON) IN FINISHED WHEAT PRODUCTS BY HUMAN CONSUMPTION AND GRAINS AND GRAIN BY-PRODUCTS USED FOR ANIMAL FEED. JUL 2010.
US FDA. GUIDANCE. ALL HOLDERS OF APPROVED VARIANCES FOR LASER LIGHT SHOWS AND DISPLAYS (LASER NOTICE 46). DEC 11, 1995.
US FDA. GUIDANCE. ALL U.S. CONDOM MANUFACTURERS, IMPORTERS AND REPACKAGERS. APR 07, 1987.
US FDA. GUIDANCE. ALLERGIC RHINITIS : DEVELOPING DRUG PRODUCTS FOR TREATMENT. SEP 2018.
US FDA. GUIDANCE. ALLOWABLE EXCESS VOLUME AND LABELED VIAL FILL SIZE IN INJECTABLE DRUG AND BIOLOGICAL PRODUCTS. JUN 2015.
US FDA. GUIDANCE. ALTERNATE SOURCE OF THE ACTIVE PHARMACEUTICAL INGREDIENT IN PENDING ANDAS. DEC 01, 2000.
US FDA. GUIDANCE. ALTERNATE WORDING FOR CAUTION STATEMENT (LASER NOTICE 30). AUG 25, 1980.
US FDA. GUIDANCE. ALTERNATIVE PROCEDURES FOR BLOOD AND BLOOD COMPONENTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. AMYOTROPHIC LATERAL SCLEROSIS : DEVELOPING DRUGS FOR TREATMENT. SEP 2019.
US FDA. GUIDANCE. AN ACCEPTABLE CIRCULAR OF INFORMATION FOR THE USE OF HUMAN BLOOD AND BLOOD COMPONENTS. MAR 2022.
US FDA. GUIDANCE. ANALYTICAL METHODS DESCRIPTION FOR TYPE C MEDICATED FEEDS. #137. MAY 8, 2007.
US FDA. GUIDANCE. ANALYTICAL PROCEDURES AND METHODS VALIDATION FOR DRUGS AND BIOLOGICS. JUL 2015.
US FDA. GUIDANCE. ANDA SUBMISSIONS - AMENDMENTS AND REQUESTS FOR FINAL APPROVAL TO TENTATIVELY APPROVED ANDAS. SEP 2020.
US FDA. GUIDANCE. ANDA SUBMISSIONS - AMENDMENTS TO ABBREVIATED NEW DRUG APPLICATIONS UNDER GDUFA. JUL 2018.
US FDA. GUIDANCE. ANDA SUBMISSIONS - CONTENT AND FORMAT. JUN 2019. REV. 1.
US FDA. GUIDANCE. ANDA SUBMISSIONS - PRIOR APPROVAL SUPPLEMENTS UNDER GDUFA. OCT 2022. REV. 2.
US FDA. GUIDANCE. ANDA SUBMISSIONS - REFUSE TO RECEIVE FOR LACK OF JUSTIFICATION OF IMPURITY LIMITS. AUG 2016.
US FDA. GUIDANCE. ANDA SUBMISSIONS - REFUSE-TO-RECEIVE STANDARDS. DEC 2016.
US FDA. GUIDANCE. ANDAS : IMPURITIES IN DRUG PRODUCTS. NOV 2010.
US FDA. GUIDANCE. ANDAS : IMPURITIES IN DRUG SUBSTANCES. JUN 2009. REV. 1.
US FDA. GUIDANCE. ANDAS : PHARMACEUTICAL SOLID POLYMORPHISM. JUL 2007.
US FDA. GUIDANCE. ANDAS : STABILITY TESTING OF DRUG SUBSTANCES AND PRODUCTS. JUN 2013.
US FDA. GUIDANCE. ANDAS : STABILITY TESTING OF DRUG SUBSTANCES AND PRODUCTS. QUESTIONS AND ANSWERS. MAY 2014.
US FDA. GUIDANCE. ANDAS FOR CERTAIN HIGHLLY PURIFIED SYNTHETIC PEPTIDE DRUG PRODUCTS THAT REFER TO LISTED DRUGS OF RDNA ORIGIN. MAY 2021.
US FDA. GUIDANCE. ANESTHETICS FOR COMPANION ANIMALS. #192. MAR 25, 2010.
US FDA. GUIDANCE. ANIMAL DRUG USER FEES : FEES EXCEED COSTS WAIVER / REDUCTION. #183. MAR 9, 2007.
US FDA. GUIDANCE. ANIMAL DRUG USER FEES AND FEE WAIVERS AND REDUCTIONS. #170. JUL 2017.
US FDA. GUIDANCE. ANIMAL GENERIC DRUG USER FEES AND FEE WAIVERS AND REDUCTIONS. #199. MAY 13, 2009.
US FDA. GUIDANCE. ANNUAL REPORTS FOR APPROVED PREMARKET APPROVAL APPLICATIONS (PMA). DEC 16, 2019.
US FDA. GUIDANCE. ANTHRAX : DEVELOPING DRUGS FOR PROPHYALXIS OF INHALATIONAL ANTHRAX. MAY 2018.
US FDA. GUIDANCE. ANTIBACTERIAL DRUG PRODUCTS : USE OF NONINFERIORITY TRIALS TO SUPPORT APPROVAL. NOV 2010.
US FDA. GUIDANCE. ANTIBACTERIAL THERAPIES FOR PATIENTS WITH AN UNMET MEDICAL NEED FOR THE TREATMENT OF SERIOUS BACTERIAL DISEASES. AUG 2017.
US FDA. GUIDANCE. ANTIDEPRESSANT DRUGS-CLINICAL EVALUATION. SEP 01, 1977.
US FDA. GUIDANCE. ANTIMICROBIAL FOOD ADDITIVES. JUN 30, 1999.
US FDA. GUIDANCE. ANTIVIRAL PRODUCT DEVELOPMENT-CONDUCTING AND SUBMITTING VIROLOGY STUDIES TO THE AGENCY : GUIDANCE FOR SUBMITTING HCV RESISTANCE DATA. JUN 02, 2006.
US FDA. GUIDANCE. ANTIVIRAL PRODUCT DEVELOPMENT-CONDUCTING AND SUBMITTING VIROLOGY STUDIES TO THE AGENCY : GUIDANCE FOR SUBMITTING HBV RESISTANCE DATA. JUN 02, 2006.
US FDA. GUIDANCE. ANTIVIRAL PRODUCT DEVELOPMENT-CONDUCTING AND SUBMITTING VIROLOGY STUDIES TO THE AGENCY : GUIDANCE FOR SUBMITTING INFLUENZA RESISTANCE DATA. JUN 02, 2006.
US FDA. GUIDANCE. ANTIVIRAL PRODUCT DEVELOPMENT-CONDUCTING AND SUBMITTING VIROLOGY STUDIES TO THE AGENCY: GUIDANCE FOR SUBMITTING HIV RESISTANCE DATA. JUN 02, 2006.
US FDA. GUIDANCE. ANTIVIRAL PRODUCT DEVELOPMENT-CONDUCTING AND SUBMITTING VIROLOGY STUDIES TO THE AGENCY. JUN 05, 2006.
US FDA. GUIDANCE. APPENDIX I (B) TO THE ICH E2B(R3) ICSRS IMPLEMENTATION GUIDE. BACKWARDS AND FORWARDS COMPATIBILITY. APR 2022. REV. 1.
US FDA. GUIDANCE. APPLICABILITY OF THE PERFORMANCE STANDARD FOR HIGH-INTENSITY MERCURY VAPOR DISCHARGE LAMPS (21 CFR 1040.30). NOV 05, 2005.
US FDA. GUIDANCE. APPLICATION OF THE FOREIGN SUPPLIER VERIFICATION PROGRAM REGULATION TO IMPORTERS OF GRAIN RAW AGRICULTURAL COMMODITIES. JAN 2018.
US FDA. GUIDANCE. APPLICATION OF THE FOREIGN SUPPLIER VERIFICATION PROGRAM REGULATION TO THE IMPORTATION OF LIVE ANIMALS. MAR 2018.
US FDA. GUIDANCE. APPLICATION USER FEES FOR COMBINATION PRODUCTS. APR 01, 2005.
US FDA. GUIDANCE. APPLYING HUMAN FACTORS AND USABILITY ENGINEERING TO MEDICAL DEVICES. FEB 3, 2016.
US FDA. GUIDANCE. APPROPRIATE USE OF VOUNTARY CONSENSUS STANDARDS IN PREMARKET SUBMISSIONS FOR MEDICAL DEVICES. SEP 14, 2018.
US FDA. GUIDANCE. APPROVAL OF ALTERNATE MEANS OF LABELING FOR LASER PRODUCTS (LASER NOTICE 53). MAR 23, 2007.
US FDA. GUIDANCE. AQUEOUS SHUNTS - 510(K) SUBMISSIONSS/STAFF. NOV 15, 1998.
US FDA. GUIDANCE. ARTHROSCOPY PUMP TUBING SETS INTENDED FOR MULTIPLE PATIENT USE - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. DEC 23, 2021.
US FDA. GUIDANCE. ASSAY MIGRATION STUDIES FOR IN VITRO DIAGNOSTIC DEVICES. APR 25, 2013.
US FDA. GUIDANCE. ASSEMBLER’S GUIDE TO DIAGNOSTIC X-RAY EQUIPMENT. FEB 21, 2023.
US FDA. GUIDANCE. ASSESSING COVID-19-RELATED SYMPTOMS IN OUTPATIENT ADULT AND ADOLESCENT SUBJECTS IN CLINICAL TRIALS OF DRUGS AND BIOLOGICAL PRODUCTS FOR COVID-19 PREVENTION OR TREATMENT. SEP 2020.
US FDA. GUIDANCE. ASSESSING DONOR SUITABILITY AND BLOOD AND BLOOD PRODUCT SAFETY IN CASES OF KNOWN OR SUSPECTED WEST NILE VIRUS INFECTION. JUN 23, 2005.
US FDA. GUIDANCE. ASSESSING THE EFFECTS OF FOOD ON DRUGS IN INDS AND NDAS - CLINICAL PHARMACOLOGY CONSIDERATIONS. JUN 2022.
US FDA. GUIDANCE. ASSESSING THE EFFECTS OF SIGNIFICANT MANUFACTURING PROCESS CHANGES, INCLUDING EMERGING TECHNOLOGIES, ON THE SAFETY AND REGULATORY STATUS OF FOOD INGREDIENTS AND FOOD CONTACT SUBSTANCES, INCLUDING FOOD INGREDIENTS THAT ARE COLOR ADDITIVES. JUN 2014.
US FDA. GUIDANCE. ASSESSING USER FEES UNDER THE BIOSIMILAR USER FEE AMENDMENTS OF 2017. JAN 2020.
US FDA. GUIDANCE. ASSESSING USER FEES UNDER THE GENERIC DRUG USER FEE AMENDMENTS OF 2017. MAY 2022.
US FDA. GUIDANCE. ASSESSING USER FEES UNDER THE PRESCRIPTION DRUG USER FEE AMENDMENTS OF 2017. NOV 2020.
US FDA. GUIDANCE. ASSESSMENT OF ABUSE POTENTIAL OF DRUGS. JAN 2017.
US FDA. GUIDANCE. ASSESSMENT OF RADIOFREQUENCY-INDUCED HEATING IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT FOR MULTI-CONFIGURATION PASSIVE MEDICAL DEVICES. MAR 22, 2016.
US FDA. GUIDANCE. ATOPIC DERMATITIS : TIMING OF PEDIATRIC STUDIES DURING DEVELOPMENT OF SYSTEMIC DRUGS. OCT 2018.
US FDA. GUIDANCE. ATTACHMENT 1. SAMPLE FORMATS. AMMONIA N 13 INJECTION, FLUDEOXYGLUCOSE F 18 INJECTION (FDG F 18) AND SODIUM FLURODIE F 18 INJECTION. AUG 2011.
US FDA. GUIDANCE. ATTACHMENT 2. SAMPLE FORMATS - FORM FDA 356H FOR AMMONIA N 13 INJECTION, FLUDEOXYGLUCOSE F 18 INJECTION (FDG F 18) AND SODIUM FLUORIDE F 18 INJECTION. JAN 25, 2011.
US FDA. GUIDANCE. ATTACHMENT TO GUIDANCE ON PHARMACOGENOMIC DATA SUBMISSIONS. EXAMPLES OF VOLUNTARY SUBMISSIONS OR SUBMISSIONS REQUIRED UNDER 21 CFR 312, 314, OR 601. MAR 2005.
US FDA. GUIDANCE. AVAILABILITY OF FDA’S ESUBMITTER PROGRAM FOR REGULATORY SUBMISSIONS FROM LICENSED BLOOD ESTABLISHMENTS. AUG 2011.
US FDA. GUIDANCE. BACTERIAL RISK CONTROL STRATEGIES FOR BLOOD COLLECTION ESTABLISHMENTS AND TRANSFUSION SERVICES TO ENHANCE THE SAFETY AND AVAILABILITY OF PLATELETS FOR TRANSFUSION. DEC 2020.
US FDA. GUIDANCE. BACTERIAL VAGINOSIS : DEVELOPING DRUGS FOR TREATMENT. AUG 2019.
US FDA. GUIDANCE. BALANCING PREMARKET AND POSTMARKET DATA COLLECTION FOR DEVICES SUBJECT TO PREMARKET APPROVAL. APR 13, 2015.
US FDA. GUIDANCE. BASIC SAFETY AND ESSENTIAL PERFORMANCE OF MEDICAL ELECTRICAL EQUIPMENT, MEDICAL ELECTRICAL SYSTEMS, AND LABORATORY MEDICAL EQUIPMENT - STANDARDS SPECIFIC INFORMATION FOR THE ACCREDITAATION SCHEME FOR CONFORMITY ASSESSMENT (ASCA) PILOT PROGRAM. SEP 25, 2020.
US FDA. GUIDANCE. BCG-UNRESPONSIVE NONMUSCLE INVASIVE BLADDER CANCER : DEVELOPING DRUGS AND BIOLOGICS FOR TREATMENT. FEB 2018.
US FDA. GUIDANCE. BEAM ATTENUATORS AND EMISSION INDICATORS FOR CLASS II AND IIIA LASER SYSTEMS (LASER NOTICE 43). JUN 07, 1993.
US FDA. GUIDANCE. BENEFIT-RISK FACTORS TO CONSIDER WHEN DETERMINING SUBSTANTIAL EQUIVALENCE IN PREMARKET NOTIFICATIONS (510(K)) WITH DIFFERENT TECHNOLOGICAL CHARACTERISTICS. SEP 25, 2018.
US FDA. GUIDANCE. BEST PRACTICES FOR COMMUNICATION BETWEEN IND SPONSORS AND FDA DURING DRUG DEVELOPMENT. DEC 2017.
US FDA. GUIDANCE. BEST PRACTICES FOR CONDUCTING AND REPORTING PHARMACOEPIDEMIOLOGIC SAFETY STUDIES USING ELECTRONIC HEALTHCARE DATA. MAY 2013.
US FDA. GUIDANCE. BEST PRACTICES FOR CONVENING A GRAS PANEL. DEC 2022.
US FDA. GUIDANCE. BEST PRACTICES IN DEVELOPING PROPRIETARY NAMES FOR HUMAN PRESCRIPTION DRUG PRODUCTS. DEC 2020.
US FDA. GUIDANCE. BIOANALYTICAL METHOD VALIDATION. MAY 2018.
US FDA. GUIDANCE. BIOAVAILABILITY STUDIES SUBMITTED IN NDAS OR INDS - GENERAL CONSIDERATIONS. APR 2022.
US FDA. GUIDANCE. BIOEQUIVALENCE : BLOOD LEVEL BIOEQUIVALENCE STUDY. VICH GL52. #224. DEC 2016.
US FDA. GUIDANCE. BIOEQUIVALENCE GUIDANCE. #35. NOV 8, 2006.
US FDA. GUIDANCE. BIOEQUIVALENCE RECOMMENDATIONS FOR SPECIFIC PRODUCTS. JUN 2010.
US FDA. GUIDANCE. BIOLOGICAL PRODUCT DEVIATION REPORTING FOR LICENSED MANUFACTURERS OF BIOLOGICAL PRODUCTS OTHER THAN BLOOD AND BLOOD COMPONENTS. OCT 2006.
US FDA. GUIDANCE. BIOLOGICAL PRODUCT DEVIATION. REPORTING FOR BLOOD AND PLASMA ESTABLISHMENTS. MAR 2020.
US FDA. GUIDANCE. BIOLOGICAL PRODUCTS : HUMAN BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURE. DEC 2014.
US FDA. GUIDANCE. BIOLOGICS LICENSE APPLICATIONS FOR MINIMALLY MANIPULATED, UNRELATED ALLOGENEIC PLACENTAL / UMBILICAL CORD BLOOD INTENDED FOR HEMATOPOIETIC AND IMMUNOLOGIC RECONSTITUTION IN PATIENTS WITH DISORDERS AFFECTING THE HEMATOPOIETIC SYSTEM. MAR 2014.
US FDA. GUIDANCE. BIOMARKERS AND SURROGATE ENDPOINTS IN CLINICAL STUDIES TO SUPPORT EFFECTIVENESS OF NEW ANIMAL DRUGS. #267. OCT 2021.
US FDA. GUIDANCE. BISPECIFIC ANTIBODY DEVELOPMENT PROGRAMS. MAY 2021.
US FDA. GUIDANCE. BLADDER CANCER : DEVELOPING DRUGS AND BIOLOGICS FOR ADJUVANT TREATMENT. JUN 2022.
US FDA. GUIDANCE. BLOOD ESTABLISHMENT COMPUTER SYSTEM VALIDATION IN THE USER’S FACILITY. APR 2013.
US FDA. GUIDANCE. BLOOD GLUCOSE MONITORING TEST SYSTEMS FOR PRESCRIPTION POINT-OF-CARE USE. SEP 29, 2020.
US FDA. GUIDANCE. BLOOD LANCET LABELING. NOV 29, 2010.
US FDA. GUIDANCE. BLUE BIRD MEDICATED FEED LABELS. #181. JUL 2019.
US FDA. GUIDANCE. BONE ANCHORS - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. MAR 3, 2020.
US FDA. GUIDANCE. BOTANICAL DRUG DEVELOPMENT. DEC 2016. REV. 1.
US FDA. GUIDANCE. BOTTLED WATER QUALITY STANDARD : ESTABLISHING AN ALLOWABLE LEVEL FOR DI(2-ETHYLHEXYL)PHTHALATE. SMALL ENTITY COMPLIANCE GUIDE. APR 2012.
US FDA. GUIDANCE. BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AND MEDICINAL PRODUCTS. VICH GL45. #198. JUL 2015.
US FDA. GUIDANCE. BREAKTHROUGH DEVICES PROGRAM. DEC 18, 2018.
US FDA. GUIDANCE. BREAST IMPLANTS - CERTAIN LABELING RECOMMENDATIONS TO IMPROVE PATIENT COMMUNICATION. SEP 29, 2020.
US FDA. GUIDANCE. BULK TRANSPORT OF JUICE CONCENTRATES AND CERTAIN SHELF-STABLE JUICES. APR 24, 2003.
US FDA. GUIDANCE. BUNDLING MULTIPLE DEVICES OR MULTIPLE INDICATIONS IN A SINGLE SUBMISSION. JUN 22, 2007.
US FDA. GUIDANCE. CALCIUM DTPA AND ZINC DTPA DRUG PRODUCTS-SUBMITTING A NEW DRUG APPLICATION. AUG 13, 2004.
US FDA. GUIDANCE. CALORIE LABELING OF ARTICLES OF FOOD IN VENDING MACHINES. SMALL ENTITY COMPLIANCE GUIDE. AUG 2016.
US FDA. GUIDANCE. CANCER CLINICAL TRIAL ELIGIBILITY CRITERIA : BRAIN METASTASES. JUL 2020.
US FDA. GUIDANCE. CANCER CLINICAL TRIAL ELIGIBILITY CRITERIA : MINIMUM AGE CONSIDERATIONS FOR INCLUSION OF PEDIATRIC PATIENTS. JUL 2020.
US FDA. GUIDANCE. CANCER CLINICAL TRIAL ELIGIBILITY CRITERIA : PATIENTS WITH HIV, HEPATITIS B VIRUS, OR HEPATITIS C VIRUS INFECTIONS. JUL 2020.
US FDA. GUIDANCE. CANCER CLINICAL TRIAL ELIGIBILITY CRITERIA : PATIENTS WITH ORGAN DYSFUNCTION OR PRIOR OR CONCURRENT MALIGNANCIES. JUL 2020.
US FDA. GUIDANCE. CANCER DRUG AND BIOLOGICAL PRODUCTS - CLINICAL DATA IN MARKETING APPLICATIONS. OCT 11, 2001.
US FDA. GUIDANCE. CANNABIS AND CANNABIS-DERIVED COMPOUNDS : QUALITY CONSIDERATIONS FOR CLINICAL RESEARCH. JAN 2023.
US FDA. GUIDANCE. CARCINOGENICITY STUDY PROTOCOL SUBMISSIONS. MAY 23, 2002.
US FDA. GUIDANCE. CARDIAC MONITOR GUIDANCE (INCLUDING CARDIOTACHOMETER AND RATE ALARM). NOV 04, 1998.
US FDA. GUIDANCE. CELL-BASED PRODUCTS FOR ANIMAL USE. #218. JUN 2015.
US FDA. GUIDANCE. CELLULAR THERAPY FOR CARDIAC DISEASE. OCT 2010.
US FDA. GUIDANCE. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) APPEALS PROCESSES : QUESTIONS AND ANSWERS ABOUT 517A. MAR 27, 2020.
US FDA. GUIDANCE. CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH) APPEALS PROCESSES. JUL 2, 2019.
US FDA. GUIDANCE. CERTAIN HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS) RECOVERED FROM DONORS WHO WERE TESTED FOR COMMUNICABLE DISEASES USING POOLED SPECIMENS OR DIAGNOSTIC TESTS. APR 2008.
US FDA. GUIDANCE. CERTAIN MILITARY LASERS EXEMPT FROM 21 CFR 1040.10 & .11 (LASER NOTICE 9). AUG 23, 1976.
US FDA. GUIDANCE. CERTAIN OPHTHALMIC PRODUCTS : POLICY REGARDING COMPLIANCE WITH 21 CFR PART 4. MAR 2022.
US FDA. GUIDANCE. CERTIFICATES OF CONFIDENTIALITY. SEP 2020.
US FDA. GUIDANCE. CGMP FOR PHASE 1 INVESTIGATIONAL DRUGS. JUL 2008.
US FDA. GUIDANCE. CHANGES OR MODIFICATIONS DURING THE CONDUCT OF A CLINICAL INVESTIGATION.. MAY 28, 2001.
US FDA. GUIDANCE. CHANGES TO AN APPROVED APPLICATION FOR SPECIFIED BIOTECHNOLOGY AND SPECIFIED SYNTHETIC BIOLOGICAL PRODUCTS. JUL 01, 1997.
US FDA. GUIDANCE. CHANGES TO AN APPROVED APPLICATION: BIOLOGICAL PRODUCTS. JUL 01, 1997.
US FDA. GUIDANCE. CHANGES TO AN APPROVED NDA OR ANDA: QUESTIONS AND ANSWERS. JAN 01, 2001.
US FDA. GUIDANCE. CHANGES TO AN APPROVED NDA OR ANDA. APR 08, 2004.
US FDA. GUIDANCE. CHANGES TO AN APPROVED NDA OR ANDA. SPECIFICATIONS – USE OF ENFORCEMENT DISCRETION FOR COMPENDIAL CHANGES. NOV 22, 2004.
US FDA. GUIDANCE. CHANGES TO APPROVED NADAS - NEW NADAS VS. CATEGORY II SUPPLEMENTAL NADAS. #191. AUG 2020.
US FDA. GUIDANCE. CHANGES TO DISPOSABLE MANUFACTURING MATERIALS : QUESTIONS AND ANSWERS. JUL 2022.
US FDA. GUIDANCE. CHANGES TO EXISTING MEDICAL SOFTWARE POLICIES RESULTING FROM SECTION 3060 OF THE 21ST CENTURY CURES ACT. SEP 27, 2019.
US FDA. GUIDANCE. CHANNELS OF TRADE POLICY FOR COMMODITIES WITH METHYL PARATHION RESIDUES. NOV 30, 2000.
US FDA. GUIDANCE. CHANNELS OF TRADE POLICY FOR COMMODITIES WITH RESIDUES OF PESTICIDE CHEMICALS, FOR WHICH TOLERANCES HAVE BEEN REVOKED, SUSPENDED, OR MODIFIED BY THE ENVIRONMENTAL PROTECTION AGENCY PURSUANT TO DIETARY RISK CONSIDERATIONS. MAY 18, 2005.
US FDA. GUIDANCE. CHANNELS OF TRADE POLICY FOR COMMODITIES WITH VINCLOZOLIN RESIDUES. JUN 12, 2002.
US FDA. GUIDANCE. CHAPTER 1 - GENERAL. .
US FDA. GUIDANCE. CHAPTER 3 - DEVICES. .
US FDA. GUIDANCE. CHAPTER 4 - HUMAN DRUGS. .
US FDA. GUIDANCE. CHAPTER 48 - 7348.809 BIORESEARCH MONITORING. SEP 26, 2018.
US FDA. GUIDANCE. CHAPTER 48 7348.809A RADIOACTIVE DRUG RESEARCH COMMITTEE. APR 16, 2018.
US FDA. GUIDANCE. CHARACTERIZATION AND QUALIFICATION OF CELL SUBSTRATES AND OTHER BIOLOGICAL MATERIALS USED IN THE PRODUCTION OF VIRAL VACCINES FOR INFECTIOUS DISEASE INDICATIONS. FEB 2010.
US FDA. GUIDANCE. CHARACTERIZATION OF ULTRAHIGH MOLECULAR WEIGHT POLYETHYLENE (UHMWPE) USED IN ORTHOPEDIC DEVICES. APR 26, 2019.
US FDA. GUIDANCE. CHECKLIST OF INFORMATION USUALLY SUBMITTED IN AN INVESTIGATIONAL DEVICE EXEMPTIONS (IDE) APPLICATION FOR REFRACTIVE SURGERY LASERS [EXCIMER]. OCT 09, 1996.
US FDA. GUIDANCE. CHEMISTRY, MANUFACTURING, AND CONTROL INFORMATION FOR HUMAN GENE THERAPY INVESTIGATIONAL NEW DRUG APPLICATIONS (INDS). JAN 2020.
US FDA. GUIDANCE. CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) INFORMATION - FERMENTATION-DERIVED INTERMEDIATES, DRUG SUBSTANCES, AND RELATED DRUG PRODUCTS FOR VETERINARY MEDICINAL USE. #216. MAR 8, 2012.
US FDA. GUIDANCE. CHEMISTRY, MANUFACTURING, AND CONTROLS CHANGES TO AN APPROVED APPLICATION : CERTAIN BIOLOGICAL PRODUCTS. JUN 2021.
US FDA. GUIDANCE. CHEMISTRY, MANUFACTURING, AND CONTROLS CHANGES TO AN APPROVED NADA OR ANADA. MAY 30, 2007.
US FDA. GUIDANCE. CHILD-RESISTANT PACKAGING STATEMENTS IN DRUG PRODUCT LABELING. AUG 2019.
US FDA. GUIDANCE. CHRONIC CUTANEOUS ULCER AND BURN WOUNDS - DEVELOPING PRODUCTS FOR TREATMENT. JUN 02, 2006.
US FDA. GUIDANCE. CHRONIC HEPATITIS B VIRUS INFECTION : DEVELOPING DRUGS FOR TREATMENT. APR 2022.
US FDA. GUIDANCE. CHRONIC HEPATITIS C VIRUS INFECTION : DEVELOPING DIRECT-ACTING ANTIVIRAL DRUGS FOR TREATMENT. NOV 2017.
US FDA. GUIDANCE. CHRONIC OBSTRUCTIVE PULMONARY DISEASE. USE OF THE ST. GEORGE’S RESPIRATORY QUESTIONNAIRE AS A PRO ASSESSMENT TOOL. MAR 2018.
US FDA. GUIDANCE. CHRONIC RHINOSINUSITIS WITH NASAL POLYPS : DEVELOPING DRUGS FOR TREATMENT. DEC 2021.
US FDA. GUIDANCE. CITIZEN PETITIONS AND PETITIONS FOR STAY OF ACTION SUBJECT TO SECTION 505(Q) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. SEP 2019. REV. 2.
US FDA. GUIDANCE. CIVIL MONEY PENALTIES AND NO-TOBACCO-SALE ORDERS FOR TOBACCO RETAILERS (REVISED)*. MAR 2023.
US FDA. GUIDANCE. CIVIL MONEY PENALTIES AND NO-TOBACCO-SALE ORDERS FOR TOBACCO RETAILERS. RESPONSES TO FREQUENTLY ASKED QUESTIONS (REVISED)*. DEC 2016.
US FDA. GUIDANCE. CIVIL MONEY PENALTIES RELATING TO THE CLINICALTRIALS.GOV DATA BANK. AUG 2020.
US FDA. GUIDANCE. CLARIFICATION OF COMPLIANCE REQUIREMENTS FOR CERTAIN MANUFACTURERS WHO INCORPORATE CERTIFIED CLASS I LASER PRODUCTS INTO THEIR PRODUCTS (LASER NOTICE 42). DEC 18, 1989.
US FDA. GUIDANCE. CLARIFICATION OF FDA AND EPA JURISDICTION OVER MOSQUITO-RELATED PRODUCTS. #236. OCT 2017.
US FDA. GUIDANCE. CLARIFICATION OF ORPHAN DESIGNATION OF DRUGS AND BIOLOGICS FOR PEDIATRIC SUBPOPULATIONS OF COMMON DISEASES. JUL 2018.
US FDA. GUIDANCE. CLARIFICATION OF RADIATION CONTROL REGULATIONS FOR DIAGNOSTIC X-RAY EQUIPMENT (FDA 89-8221). FEB 28, 1989.
US FDA. GUIDANCE. CLARIFICATION OF RADIATION CONTROL REGULATIONS FOR DIAGNOSTIC X-RAY EQUIPMENT (PART 1 ). MAR 01, 1989.
US FDA. GUIDANCE. CLARIFICATION OF RADIATION CONTROL REGULATIONS FOR DIAGNOSTIC X-RAY EQUIPMENT (PART 2). MAR 01, 1989.
US FDA. GUIDANCE. CLARIFICATION OF RADIATION CONTROL REGULATIONS FOR DIAGNOSTIC X-RAY EQUIPMENT (PART 3). MAR 01, 1989.
US FDA. GUIDANCE. CLARIFICATION ON FOOD ESTABLISHMENT WAIVER FROM REQUIREMENTS OF THE SANITARY TRANSPORTATION OF HUMAN AND ANIMAL FOOD RULE. AUG 2017.
US FDA. GUIDANCE. CLASS II AND IIIA LASER LIGHT SHOW PROJECTORS AND SHOWS (LASER NOTICE 40). OCT 29, 1987.
US FDA. GUIDANCE. CLASS II SPECIAL CONTROLS GUIDANCE DOCUMENT: IMMUNOMAGNETIC CIRCULATING CANCER CELL SELECTION AND ENUMERATION SYSTEM (PDF VERSION). MAY 11, 2004.
US FDA. GUIDANCE. CLASS II SPECIAL CONTROLS GUIDANCE DOCUMENT: SEROLOGICAL ASSAYS FOR THE DETECTION OF BETA-GLUCAN (PDF VERSION). SEP 23, 2004.
US FDA. GUIDANCE. CLASSIFICATION AND REQUIREMENTS FOR LASER ILLUMINATED PROJECTORS (LIPS) (LASER NOTICE NO. 57). MAY 8, 2019.
US FDA. GUIDANCE. CLASSIFICATION OF POSTERIOR CERVICAL SCREW SYTEMS : SMALL ENTITY COMPLIANCE GUIDE. MAY 4, 2020.
US FDA. GUIDANCE. CLASSIFICATION OF PRODUCTS AS DRUGS AND DEVICES AND ADDITIONAL PRODUCT CLASSIFICATION ISSUES. SEP 2017.
US FDA. GUIDANCE. CLINICAL CONSIDERATIONS FOR INVESTIGATIONAL DEVICE EXEMPTIONS (IDES) FOR NEUROLOGICAL DEVICES TARGETING DISEASE PROGRESSION AND CLINICAL OUTCOMES. NOV 7, 2016.
US FDA. GUIDANCE. CLINICAL CONSIDERATIONS FOR THERAPEUTIC CANCER VACCINES. OCT 2011.
US FDA. GUIDANCE. CLINICAL DATA NEEDED TO SUPPORT THE LICENSURE OF PANDEMIC INFLUENZA VACCINES. MAY 2007.
US FDA. GUIDANCE. CLINICAL DATA NEEDED TO SUPPORT THE LICENSURE OF SEASONAL INACTIVATED INLUENZA VACCINES. MAY 2007.
US FDA. GUIDANCE. CLINICAL DATA PRESENTATIONS FOR ORTHOPEDIC DEVICE APPLICATIONS -GUIDANCE FOR INDUSTRY AND FDA STAFF. DEC 01, 2004.
US FDA. GUIDANCE. CLINICAL DECISION SUPPORT SOFTWARE. SEP 28, 2022.
US FDA. GUIDANCE. CLINICAL DEVELOPMENT AND LABELING OF ANTI-INFECTIVE DRUG PRODUCTS. FEB 12, 2001.
US FDA. GUIDANCE. CLINICAL DEVELOPMENT PROGRAMS FOR DRUGS, DEVICES, AND BIOLOGICAL PRODUCTS FOR THE TREATMENT OF RHEUMATOID ARTHRITIS (RA). FEB 17, 1999.
US FDA. GUIDANCE. CLINICAL DRUG INTERACTION STUDIES - CYTOCHROME P450 ENZYME- AND TRANSPORTER-MEDIATED DRUG INTERACTIONS. JAN 2020.
US FDA. GUIDANCE. CLINICAL EVALUATION OF ANTIEPILEPTIC DRUGS (ADULTS AND CHILDREN). JAN 01, 1981.
US FDA. GUIDANCE. CLINICAL EVALUATION OF GENERAL ANESTHETICS. MAY 01, 1982.
US FDA. GUIDANCE. CLINICAL INVESTIGATIONS FOR PROSTATE TISSUE ABLATION DEVICES. JUL 15, 2020.
US FDA. GUIDANCE. CLINICAL INVESTIGATIONS OF DEVICES INDICATAED FOR THE TREATMENT OF URINARY INCONTINENCE. MAR 8, 2011.
US FDA. GUIDANCE. CLINICAL INVESTIGATOR REGULATORY SANCTIONS - INFORMATION SHEET. JAN 01, 1998.
US FDA. GUIDANCE. CLINICAL INVESTSIGATOR ADMINISTRATIVE ACTIONS - DISQUALIFICATION. INFORMATION SHEET. MAR 2014.
US FDA. GUIDANCE. CLINICAL PERFORMANCE ASSESSMENT : CONSIDERATIONS FOR COMPUTER-ASSISTED DETECTION DEVICES APPLIED TO RADIOLOGY IMAGES AND RADIOLOGY DEVICE DATA IN - PREMARKET NOTIFICATIONS (510(K)) SUBMISSIONS. SEP 28, 2022.
US FDA. GUIDANCE. CLINICAL PHARMACOGENOMICS : PREMARKET EVALUATION IN EARLY-PHASE CLINICAL STUDIES AND RECOMMENDATIONS FOR LABELING. JAN 2013.
US FDA. GUIDANCE. CLINICAL PHARMACOLOGY DATA TO SUPPORT A DEMONSTRATION OF BIOSIMILARITY TO A REFERENCE PRODUCT. DEC 2016.
US FDA. GUIDANCE. CLINICAL STUDIES SECTION OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS — CONTENT AND FORMAT. JAN 24, 2006.
US FDA. GUIDANCE. CLINICAL STUDY DESIGNS FOR CATHETER ABLATION DEVICES FOR TREATMENT OF ATRIAL FLUTTER. AUG 5, 2008.
US FDA. GUIDANCE. CLINICAL STUDY DESIGNS FOR PERCUTANEOUS CATHETER ABLATION FOR TREATMENT OF ATRIAL FIBRILLATION. JAN 08, 2004.
US FDA. GUIDANCE. CLINICAL STUDY DESIGNS FOR SURGICAL ABLATION DEVICES FOR TREATMENT OF ATRIAL FIBRILLATION. FEB 15, 2013.
US FDA. GUIDANCE. CLINICAL TRIAL CONSIDERATIONS: VERTEBRAL AUGMENTATION DEVICES TO TREAT SPINAL INSUFFICIENCY FRACTURES - GUIDANCE FOR INDUSTRY AND FDA STAFF. OCT 23, 2004.
US FDA. GUIDANCE. CLINICAL TRIAL ENDPOINTS FOR THE APPROVAL OF CANCER DRUGS AND BIOLOGICS. DEC 2018.
US FDA. GUIDANCE. CLINICAL TRIAL ENDPOINTS FOR THE APPROVAL OF NON-SMALL CELL LUNG CANCER DRUGS AND BIOLOGICS. APR 2015.
US FDA. GUIDANCE. CLINICAL TRIAL IMAGING ENDPOINT PROCESS STANDARDS. APR 2018.
US FDA. GUIDANCE. CMC POSTAPPROVAL MANUFACTURING CHANGES FOR SPECIFIED BIOLOGICAL PRODUCTS TO BE DOCUMENTED IN ANNUAL REPORTS. DEC 2021.
US FDA. GUIDANCE. CMC POSTAPPROVAL MANUFACTURING CHANGES TO BE DOCUMENTED IN ANNUAL REPORTS. MAR 2014.
US FDA. GUIDANCE. COAGULATION SYSTEM FOR MEASUREMENT OF VISCOELASTIC PROPERTIES : ENFORCEMENT PLICY DURING THE CORNAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY (REVISED). JAN 28, 2021.
US FDA. GUIDANCE. CODEVELOPMENT OF TWO OR MORE NEW INVESTIGATIONAL DRUGS FOR USE IN COMBINATION. JUN 2013.
US FDA. GUIDANCE. COLLECTION OF PLATELETS BY AUTOMATED METHODS. DEC 2007.
US FDA. GUIDANCE. COLLECTION OF RACE AND ETHNICITY DATA IN CLINICAL TRIALS. OCT 26, 2016.
US FDA. GUIDANCE. COLOR ADDITIVE PETITIONS - FDA RECOMMENDATIONS FOR SUBMISSION OF CHEMICAL AND TECHNOLOGICAL DATA ON COLOR ADDITIVES FOR FOOD, DRUGS, COSMETICS, OR MEDICAL DEVICES. JUL 2009.
US FDA. GUIDANCE. COLOR ADDITIVE PETITIONS - MEDICAL DEVICES. JUN 01, 1987.
US FDA. GUIDANCE. COLORED SEA SALT. SEP 2015.
US FDA. GUIDANCE. COMMERCIALLY DISTRIBUTED ANALYTE SPECIFIC REAGENTS (ASRS) : FREQUENTLY ASKED QUESTIONS. SEP 14, 2007.
US FDA. GUIDANCE. COMMUNITY-ACQUIRED BACTERIAL PNEUMONIA : DEVELOPING DRUGS FOR TREATMENT. JUN 2020.
US FDA. GUIDANCE. COMPARABILITY PROTOCOLS - CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR NEW ANIMAL DRUGS. #156. APR 2016.
US FDA. GUIDANCE. COMPARABILITY PROTOCOLS FOR POSTAPPROVAL CHANGES TO THE CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION IN AN NDA, ANDA, OR BLA. OCT 2022.
US FDA. GUIDANCE. COMPETITIVE GENERIC THERAPIES. OCT 2022. REV. 1.
US FDA. GUIDANCE. COMPLETENESS ASSESSMENTS FOR TYPE II API DMFS UNDER GDUFA. OCT 2017. REV. 1.
US FDA. GUIDANCE. COMPLIANCE GUIDANCE: THE MAMMOGRAPHY QUALITY STANDARDS ACT FINAL REGULATIONS: PREPARING FOR MQSA INSPECTIONS. NOV 04, 2001.
US FDA. GUIDANCE. COMPLIANCE GUIDE FOR CABINET X-RAY SYSTEMS. SEP 19, 2007.
US FDA. GUIDANCE. COMPLIANCE GUIDE FOR LASER PRODUCTS (FDA 86-8260). JUN 01, 1992.
US FDA. GUIDANCE. COMPLIANCE POLICY FOR CERTAIN COMPOUNDING OF ORAL OXITRIPTAN (5-HTP) DRUG PRODUCTS FOR PATIENTS WITH TETRAHYDROBIOPTERIN (BH4) DEFICIENCY. JUL 2019.
US FDA. GUIDANCE. COMPLIANCE POLICY FOR CERTAIN LABELING AND WARNING STATEMENT REQUIREMENTS FOR CIGARS AND PIPE TOBACCO. AUG 2018.
US FDA. GUIDANCE. COMPLIANCE POLICY FOR COMBINATION PRODUCT POSTMARKETING SAFETY REPORTING. APR 2019.
US FDA. GUIDANCE. COMPLIANCE POLICY FOR LIMITED MODIFICATIONS TO CERTAIN MARKETED TOBACCO PRODUCTS. NOV 2019.
US FDA. GUIDANCE. COMPLIANCE POLICY FOR REQUIRED WARNING STATEMENTS ON SMALL-PACKAGED CIGARS. AUG 2018.
US FDA. GUIDANCE. COMPLIANCE POLICY FOR THE QUANTITY OF BIOAVAILABILITY AND BIOEQUIVALENCE SAMPLES RETAINED UNDER 21CFR320.38(C). AUG 2020.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE SEC. 390.100 DEFINITION OF “COMMERCE” 21 CFR 1000.3(D) 2. .
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE SECTION 110.800 POST DETENTION SAMPLING. MAR 2020.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. CPG SEC 280.100 : STABILITY REQUIREMENTS - LICENSED IN VITRO DIAGNOSTIC PRODUCTS. JUL 2020.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. CPG SEC. 230.150 : BLOOD DONOR CLASSIFICATION STATEMENT, PAID OR VOLUNTEER DONOR. DEC 2019.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. CPG SEC. 280.110 : MICROBIOLOGICAL CONTROL REQUIREMENTS - LICENSED ANTI-HUMAN GLOBULIN AND BLOOD GROUPING REAGENTS. JUL 2020.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. SEC. 150.200 COMPLIANCE REVIEW OF PRIVATE LABORATORY ANALYTICAL PACKAGES (PLAPS). SEP 2016.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. SEC. 555.400 AFLATOXINS IN HUMAN FOOD.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. SEC. 570.200 AFLATOXINS IN BRAZIL NUTS. JUN 2021.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. SEC. 570.375 AFLATOXINS IN PEANUTS AND PEANUT PRODUCTS. JUN 2021.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. SEC. 570.500 AFLATOXINS IN PISTACHIO NUTS. JUN 2021.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. SEC. 690.150 LABELING AND MARKETING OF DOG AND CAT FOOD DIETS INTENDED TO DIAGNOSE, CURE, MITIGATE, TREAT, OR PREVENT DISEASES. APR 2016.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDE. SECTION 101.100 FDA CONSIDERATIONS FOR RECOMMENDING CHARGES UNDER 21 U.S.C. 331(A) OR (D) FOR CAUSING THE INTRODUCTION OF VIOLATIVE PRODUCTS INTO INTERSTATE COMMERCE. OCT 2016.
US FDA. GUIDANCE. COMPLIANCE POLICY GUIDES INDEX. .
US FDA. GUIDANCE. COMPLIANCE WITH 21 CFR PART 1271.150(C)(1) – MANUFACTURING ARRANGEMENTS. SEP 08, 2006.
US FDA. GUIDANCE. COMPLIANCE WITH PROVIDING AN ACCEPTABLE UNIQUE FACILITY IDENTIFIER FOR THE FOREIGN SUPPLIER VERIFICATION PROGRAMS FOR FOOD IMPORTERS REGULATION. APR 2022.
US FDA. GUIDANCE. COMPLIANCE WITH REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AN SMOKELESS TOBACCO TO PROTECT CHILDREN AND ADOLESCENTS. AUG 2013.
US FDA. GUIDANCE. COMPLIANCE WITH SECTION 301 OF THE MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002, AS AMENDED – PROMINENT AND CONSPICUOUS MARK OF MANUFACTURERS ON SINGLE-USE DEVICES. MAY 01, 2006.
US FDA. GUIDANCE. COMPLIANCY POLICY GUIDE. CPG SEC. 110.650 WEEKLY ENTRY FILING. NOV 2020.
US FDA. GUIDANCE. COMPLICATED INTRA-ABDOMINAL INFECTIONS : DEVELOPING DRUGS FOR TREATMENT. MAY 2018. REV. 1.
US FDA. GUIDANCE. COMPLICATED URINARY TRACT INFECTIONS : DEVELOPING DRUGS FOR TREATMENT. JUN 2018. REV. 1.
US FDA. GUIDANCE. COMPOUNDED DRUG PRODUCTS THAT ARE ESSENTIALLY COPIES OF A COMMERCIALLY AVAILABLE DRUG PRODUCT UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. JAN 2018.
US FDA. GUIDANCE. COMPOUNDED DRUG PRODUCTS THAT ARE ESSENTIALLY COPIES OF APPROVED DRUG PRODUCTS UNDER SECTION 503B OF THE FEDERAL, FOOD, DRUG AND COSMETIC ACT. JAN 2018.
US FDA. GUIDANCE. COMPOUNDING AND REPACKAGING BY RADIOPHARMACEUTICALS BY OUTSOURCING FACILITIES. SEP 2018.
US FDA. GUIDANCE. COMPOUNDING AND REPACKAGING OF RADIOPHARMACEUTICALS BY STATE-LICENSED NUCLEAR PHARMACIES, FEDERAL FACILITIES, AND CERTAIN OTHER ENTITIES. SEP 2018.
US FDA. GUIDANCE. COMPOUNDING ANIMAL DRUGS FROM BULK DRUG SUBSTANCES. #256. AUG 2022.
US FDA. GUIDANCE. COMPOUNDING CERTAIN BETA-LACTAM PRODUCTS IN SHORTAGE UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. NOV 2022.
US FDA. GUIDANCE. COMPOUNDING CERTAIN IBUPROFEN ORAL SUSPENSION PRODUCTS UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. FEB 2023.
US FDA. GUIDANCE. COMPUTER-ASSISTED DETECTION DEVICES APPLIED TO RADIOLOGY IMAGES AND RADIOLOGY DEVICE DATA - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. SEP 28, 2022.
US FDA. GUIDANCE. COMPUTERIZED SYSTEMS USED IN CLINICAL INVESTIGATIONS. MAY 2007.
US FDA. GUIDANCE. CONCERNS RELATED TO THE USE OF CLOVE OIL AS AN ANESTHETIC FOR FISH. #150. APR 24, 2007.
US FDA. GUIDANCE. CONDITIONS FOR SALE FOR AIR-CONDUCTION HEARING AIDS. DEC 12, 2016.
US FDA. GUIDANCE. CONDUCT OF CLINICAL TRIALS OF MEDICAL PRODUCTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. AUG 30, 2021.
US FDA. GUIDANCE. CONSIDERATION OF UNCERTAINTY IN MAKING BENEFIT-RISK DETERMINATIONS IN MEDICAL DEVICE PREMARKET APPROVALS, DE NOVO CLASSIFICATIONS, AND HUMANITARIAN DEVICE EXEMPTIONS. AUG 30, 2019.
US FDA. GUIDANCE. CONSIDERATIONS FOR ALLOGENEIC PANCREATIC ISLET CELL PRODUCTS. SEP 2009.
US FDA. GUIDANCE. CONSIDERATIONS FOR DESIGN, DEVELOPMENT, AND ANALYTICAL VALIDATION OF NEXT GENERATION SEQUENCING (NGS) - BASED IN VITRO DIAGNOSTICS (IVDS) INTENDED TO AID IN THE DIAGNOSIS OF SUSPECTED GERMLINE DISEASES. APR 13, 2018.
US FDA. GUIDANCE. CONSIDERATIONS FOR DETERMINING WHETHER A MEASURE PROVIDES THE SAME LEVEL OF PUBLIC HEALTH PROTECTION AS THE CORRESPONDING REQUIREMENT IN 21 CFR PART 112 OR THE PREVENTIVE CONTROLS REQUIREMENTS IN PART 117 OR 507. JAN 2018.
US FDA. GUIDANCE. CONSIDERATIONS FOR DEVELOPMENTAL TOXICITY STUDIES FOR PREVENTIVE AND THERAPEUTIC VACCINES FOR INFECTIOUS DISEASE INDICATIONS. FEB 01, 2006.
US FDA. GUIDANCE. CONSIDERATIONS FOR PLASMID DNA VACCINES FOR INFECTIOUS DISEASE INDICATIONS. NOV 2007.
US FDA. GUIDANCE. CONSIDERATIONS FOR THE DESIGN OF EARLY-PHASE CLINICAL TRIALS OF CELLULAR AND GENE THERAPY PRODUCTS. JUN 2015.
US FDA. GUIDANCE. CONSIDERATIONS FOR THE DEVELOPMENT OF DRIED PLASMA PRODUCTS INTENDED FOR TRANSFUSION. DEC 2019.
US FDA. GUIDANCE. CONSIDERATIONS FOR THE INCLUSION OF ADOLESCENT PATIENTS IN ADULT ONCOLOGY CLINICAL TRIALS. MAR 2019.
US FDA. GUIDANCE. CONSIDERATIONS FOR USE OF HISTOPATHOLOGY AND ITS ASSOCIATED METHODOLOGIES TO SUPPORT BIOMARKER QUALIFICATION. MAY 2016.
US FDA. GUIDANCE. CONSIDERATIONS IN DEMONSTRATING INTERCHANGEABILITY WITH A REFERENCE PRODUCT. MAY 2019.
US FDA. GUIDANCE. CONSIDERATIONS REGARDING SUBSTANCES ADDED TO FOODS, INCLUDING BEVERAGES AND DIETARY SUPPLEMENTS. JAN 2014.
US FDA. GUIDANCE. CONSIDERATIONS WHEN TRANSFERRING CLINICAL INVESTIGATION OVERSIGHT TO ANOTHER IRB. MAY 2014.
US FDA. GUIDANCE. CONSIDERING WHETHER AN FDA-REGULATED PRODUCT INVOLVES THE APPLICATION OF NANOTECHNOLOGY. JUN 2014.
US FDA. GUIDANCE. CONSULTATION PROCEDURES UNDER FDA'S 1992 STATEMENT OF POLICY FOR FOODS DERIVED FROM NEW PLANT VARIETIES. OCT 01, 1997.
US FDA. GUIDANCE. CONSUMER ANTISEPTIC RUB FINAL RULE - QUESTIONS AND ANSWERS. SMALL ENTITY COMPLIANCE GUIDE. DEC 2020.
US FDA. GUIDANCE. CONSUMER ANTISEPTIC WASH FINAL RULE. QUESTIONS AND ANSWERS. JUL 2017.
US FDA. GUIDANCE. CONSUMER-DIRECTED BROADCAST ADVERTISEMENTS. AUG 01, 1999.
US FDA. GUIDANCE. CONTAINER AND CLOSURE SYSTEM INTEGRITY TESTING IN LIEU OF STERILITY TESTING AS A COMPONENT OF THE STABILITY PROTOCOL FOR STERILE PRODUCTS. FEB 2008.
US FDA. GUIDANCE. CONTAINER CLOSURE SYSTEMS FOR PACKAGING HUMAN DRUGS AND BIOLOGICS - QUESTIONS AND ANSWERS. MAY 01, 2002.
US FDA. GUIDANCE. CONTAINER CLOSURE SYSTEMS FOR PACKAGING HUMAN DRUGS AND BIOLOGICS. JUL 07, 1999.
US FDA. GUIDANCE. CONTENT AND FORMAT FOR ABBREVIATED 510(K)S FOR EARLY GROWTH RESPONSE 1 (EGR1) GENE FLUORESCENCE IN-SITU HYBRIDIZATION (FISH) TEST SYSTEM FOR SPECIMEN CHARACTERIZATION DEVICES. JUN 17, 2015.
US FDA. GUIDANCE. CONTENT AND FORMAT OF CHEMISTRY, MANUFACTURING AND CONTROLS INFORMATION AND ESTABLISHMENT DESCRIPTION INFORMATION FOR A BIOLOGICAL IN VITRO DIAGNOSTIC PRODUCT. MAR 08, 1999.
US FDA. GUIDANCE. CONTENT AND FORMAT OF CHEMISTRY, MANUFACTURING AND CONTROLS INFORMATION AND ESTABLISHMENT DESCRIPTION INFORMATION FOR A VACCINE OR RELATED PRODUCT.. JAN 05, 1999.
US FDA. GUIDANCE. CONTENT AND FORMAT OF INDS FOR PHASE 1 STUDIES OF DRUGS, INCLUDING WELL-CHARACTERIZED, THERAPEUTIC, BIOTECHNOLOGY-DERIVED PRODUCTS. QUESTIONS AND ANSWERS Q&A. OCT 01, 2000.
US FDA. GUIDANCE. CONTENT AND FORMAT OF INVESTIGATIONAL NEW DRUG APPLICATIONS (INDS) FOR PHASE 1 STUDIES OF DRUGS, INCLUDING WELL-CHARACTERIZED, THERAPEUTIC, BIOTECHNOLOGY-DERIVED PRODUCTS. NOV 01, 1995.
US FDA. GUIDANCE. CONTENT AND FORMAT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR LIQUID CHEMICAL STERILANTS/HIGH LEVEL DISINFECTANTS - GUIDANCE FOR INDUSTRY AND FDA REVIEWERS. JAN 02, 2000.
US FDA. GUIDANCE. CONTENT AND REVIEW OF CHEMISTRY, MANUFACTURING, AND CONTROL (CMC) INFORMATION FOR HUMAN SOMATIC CELL THERAPY INVESTIGATIONAL NEW DRUG APPLICATIONS (INDS). APR 2008.
US FDA. GUIDANCE. CONTENT OF INVESTIGATIONAL DEVICE EXEMPTIONS FOR SOLUTIONS FOR HYPOTHERMIC FLUSHING, TRANSPORT AND STORAGE OF ORGANS FOR TRANSPLANTATION - GUIDANCE FOR INDUSTRY AND FDA REVIEWERS. JAN 15, 2001.
US FDA. GUIDANCE. CONTENT OF PREMARKET SUBMISSIONS FOR MANAGEMENT OF CYBERSECURITY IN MEDICAL DEVICES. OCT 2, 2014.
US FDA. GUIDANCE. CONTENTS OF A COMPLETE SUBMISSION FOR THE EVALUATION OF PROPRIETARY NAMES. APR 2016. REV. 1.
US FDA. GUIDANCE. CONTRACT MANUFACTURING ARRANGEMENTS FOR DRUGS : QUALITY AGREEMENTS. NOV 2016.
US FDA. GUIDANCE. CONTROL OF NITROSAMINE IMPURITIES IN HUMAN DRUGS. FEB 2021. REV 1.
US FDA. GUIDANCE. CONVENIENCE KITS INTERIM REGULATORY GUIDANCE. MAY 19, 1997.
US FDA. GUIDANCE. CONVENTIONAL FOLEY CATHETERS - PERFORMANCE CRITERIA FOR SAFETY AND PERFORMANCE BASED PATHWAY. AUG 14, 2020.
US FDA. GUIDANCE. CONVERTING UNITS OF MEASURE FOR FOLATE, NIACIN, AND VITAMINS A, D, AND E ON THE NUTRITION AND SUPPLEMENT FACTS LABELS. AUG 2019.
US FDA. GUIDANCE. COOPERATIVE MANUFACTURING ARRANGEMENTS FOR LICENSED BIOLOGICS. NOV 2008.
US FDA. GUIDANCE. COOPERATIVE RESEARCH. JAN 01, 1998.
US FDA. GUIDANCE. COORDINATED DEVELOPMENT OF ANTIMICROBIAL DRUGS AND ANTIMICROBIAL SUSCEPTIBILITY TEST DEVICES. FEB 1. 2019.
US FDA. GUIDANCE. CORONARY AND CAROTID EMBOLIC PROTECTION DEVICES - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. FEB 15, 2008.
US FDA. GUIDANCE. CORONARY AND PERIPHERAL ARTERIAL DIAGNOSTIC CATHETERS . JUL 14, 2003.
US FDA. GUIDANCE. CORONARY, PERIPHERAL, AND NEUROVASCULAR GUIDEWIRES - PERFORMANCE TESTS AND RECOMMENDED LABELING. OCT 10, 2019.
US FDA. GUIDANCE. COURT DECISIONS, ANDA APPROVALS, AND 180-DAY EXCLUSIVITY UNDER THE HATCH-WAXMAN AMENDMENTS TO THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. MAR 27, 2000.
US FDA. GUIDANCE. COVER LETTER ATTACHMENTS FOR CONTROLLED CORRESPONDENCES AND ANDA SUBMISSIONS. DEC 2021.
US FDA. GUIDANCE. COVID-19 : DEVELOPING DRUGS AND BIOLOGICAL PRODUCTS FOR TREATMENT OR PREVENTION. FEB 2021.
US FDA. GUIDANCE. COVID-19 : MASTER PROTOCOLS EVALUATING DRUGS AND BIOLOGICAL PRODUCTS FOR TREATMENT OR PREVENTION. MAY 2021.
US FDA. GUIDANCE. COVID-19 CONTAINER CLOSURE SYSTEM AND COMPONENT CHANGES : GLASS VIALS AND STOPPERS. MAR 2021.
US FDA. GUIDANCE. COVID-19 PUBLIC HEALTH EMERGENCY : GENERAL CONSIDERATIONS FOR PRE-IND MEETING REQUESTS FOR COVID-19 RELATED DRUGS AND BIOLOGICAL PRODUCTS. MAY 2020.
US FDA. GUIDANCE. COVID-19 PUBLIC HEALTH EMERGENCY : POLICY ON COIVD-19-RELATED SNITATION TUNNELS. FEB 2022.
US FDA. GUIDANCE. COVID-19: POTENCY ASSAY CONSIDERATIONS FOR MONOCLONAL ANTIBODIES AND OTHER THERAPEUTIC PROTEINS TARGETING SARS-COV-2 INFECTIVITY. JAN 2021.
US FDA. GUIDANCE. CRITERIA FOR SIGNIFICANT RISK INVESTIGATIONS OF MAGNETIC RESONANCE DIAGNOSTIC DEVICES. JUN 20, 2014.
US FDA. GUIDANCE. CRITIAL PATH INNOVATION MEETINGS. APR 2015.
US FDA. GUIDANCE. CROSS LABELING ONCOLOGY DRUGS IN COMBINATION REGIMENS. NOV 2022.
US FDA. GUIDANCE. CURRENT GOOD MANUFACTURING PRACTICE AND PREVENTIVE CONTROLS, FOREIGN SUPPLIER VERIFICATION PROGRAMS, INTENTIONAL ADULTERATION, AND PRODUCE SAFETY REGULATIONS : ENFORCEMENT POLICY REGARDING CERTAIN PROVISIONS. MAR 2022.
US FDA. GUIDANCE. CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS FOR COMBINATION PRODUCTS. JAN 2017.
US FDA. GUIDANCE. CURRENT GOOD MANUFACTURING PRACTICE REQUIREMENTS FOR FOOD FOR ANIMALS. #235. OCT 2017.
US FDA. GUIDANCE. CURRENT GOOD TISSUE PRACTICE (CGTP) AND ADDITIONAL REQUIREMENTS FOR MANUFACTURERS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS). DEC 2011.
US FDA. GUIDANCE. CUSTOM DEVICE EXEMPTION. SEP 24, 2014.
US FDA. GUIDANCE. CUTANEOUS ELECTRODES FOR RECORDING PURPOSES - PERFORMANCED CRITERIA FOR SAFETY AND PERFORMANCE BASED PATHWAY. AUG 14, 2020.
US FDA. GUIDANCE. CVM GFI #104 CONTENT AND FORMAT OF EFFECTIVENESS AND TARGET ANIMAL SAFETY TECHNICAL SECTIONS AND FINAL STUDY REPORTS FOR SUBMISSION. JUL 10, 2001.
US FDA. GUIDANCE. CVM GFI #115 (VICH GL22) SAFETY STUDIES FOR VETERINARY DRUG RESIDUES IN HUMAN FOOD: REPRODUCTION TOXICITY TESTING. JUL 27, 2006.
US FDA. GUIDANCE. CVM GFI #118 MASS SPECTROMETRY FOR CONFIRMATION OF IDENTITY OF ANIMAL DRUG RESIDUES. MAY 01, 2003.
US FDA. GUIDANCE. CVM GFI #119 HOW CVM INTENDS TO HANDLE DEFICIENT SUBMISSIONS FILED DURING THE INVESTIGATION OF A NEW ANIMAL DRUG. AUG 29, 2002.
US FDA. GUIDANCE. CVM GFI #122 MANUFACTURE AND LABELING OF RAW MEAT FOODS FOR COMPANION AND CAPTIVE NONCOMPANION CARNIVORES AND OMNIVORES. NOV 09, 2004.
US FDA. GUIDANCE. CVM GFI #123 DEVELOPMENT OF DATA SUPPORTING APPROVAL OF NSAIDS FOR USE IN ANIMALS. JAN 05, 2006.
US FDA. GUIDANCE. CVM GFI #126 BACPAC I-INTERMEDIATES IN DRUG SUBSTANCE SYNTHESIS BULK ACTIVES POSTAPPROVAL CHANGES: CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION. JUN 01, 2006.
US FDA. GUIDANCE. CVM GFI #135 VALIDATION OF ANALYTICAL PROCEDURES FOR TYPE C MEDICATED FEEDS. NOV 07, 2005.
US FDA. GUIDANCE. CVM GFI #13EVALUATION OF EFFECTIVENESS OF NEW ANIMAL DRUGS FOR USE IN FREE-CHOICE FEEDS-MEDICATED BLOCK. DEC 31, 1984.
US FDA. GUIDANCE. CVM GFI #141 (VICH GL28) STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: CARCINOGENICITY TESTING. JUL 27, 2006.
US FDA. GUIDANCE. CVM GFI #144 (VICH GL27) PRE-APPROVAL INFORMATION FOR REGISTRATION OF NEW VETERINARY MEDICINAL PRODUCTS FOR FOOD-PRODUCING ANIMALS WITH RESPECT TO ANTIMICROBIAL RESISTANCE. APR 27, 2004.
US FDA. GUIDANCE. CVM GFI #147 (VICH GL31) STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: REPEAT-DOSE (90 DAY) TOXICITY TESTING. JUL 27, 2006.
US FDA. GUIDANCE. CVM GFI #148 (VICH GL32) STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: DEVELOPMENTAL TOXICITY TESTING. JUL 27, 2006.
US FDA. GUIDANCE. CVM GFI #160 (VICH GL37) STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD: REPEAT-DOSE (CHRONIC) TOXICITY TESTING. JUL 27, 2006.
US FDA. GUIDANCE. CVM GFI #166 (VICH GL38) ENVIRONMENTAL IMPACT ASSESSMENTS (EIA'S) FOR VETERINARY MEDICINAL PRODUCTS (VMP’S) - PHASE II. JAN 09, 2006.
US FDA. GUIDANCE. CVM GFI #173 ANIMAL DRUG SPONSOR FEES UNDER THE ANIMAL DRUG USER FEE ACT (ADUFA). FEB 07, 2005.
US FDA. GUIDANCE. CVM GFI #173 APPENDIX FOR THE ANIMAL DRUG SPONSOR FEES UNDER ADUFA. FEB 07, 2005.
US FDA. GUIDANCE. CVM GFI #176 (VICH GL39) SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW VETERINARY DRUG SUBSTANCES AND NEW MEDICINAL PRODUCTS: CHEMICAL SUBSTANCES. JUN 14, 2006.
US FDA. GUIDANCE. CVM GFI #177 (VICH GL40) TEST PROCEDURES/ACCEPTANCE CRITERIA FOR NEW BIOTECHNOLOGICAL/BIOLOGICAL VETERINARY MEDICINAL PRODUCTS. JUN 14, 2006.
US FDA. GUIDANCE. CVM GFI #23 MEDICATED FREE CHOICE FEEDS--MANUFACTURING CONTROL. JUN 30, 1985.
US FDA. GUIDANCE. CVM GFI #24 DRUG COMBINATIONS FOR USE IN ANIMALS. SEP 30, 1983.
US FDA. GUIDANCE. CVM GFI #37 EVALUATION OF EFFECTIVENESS OF NEW ANIMAL DRUGS FOR USE IN POULTRY FEED FOR PIGMENTATION. FEB 29, 1984.
US FDA. GUIDANCE. CVM GFI #38 GUIDELINE FOR EFFECTIVENESS EVALUATION OF TOPICAL/OTIC ANIMAL DRUGS. AUG 20, 1984.
US FDA. GUIDANCE. CVM GFI #45 GUIDELINE FOR UNIFORM LABELING OF DRUGS FOR DAIRY AND BEEF CATTLE. JUL 31, 1993.
US FDA. GUIDANCE. CVM GFI #49 TARGET ANIMAL SAFETY AND DRUG EFFECTIVENESS STUDIES FOR ANTI-MICROBIAL BOVINE MASTITIS PRODUCTS (LACTATING AND NON-LACTATING COW PRODUCTS). APR 03, 1996.
US FDA. GUIDANCE. CVM GFI #50 TARGET ANIMAL AND HUMAN FOOD SAFETY, DRUG EFFICACY, ENVIRONMENTAL AND MANUFACTURING STUDIES FOR TEAT ANTISEPTIC PRODUCTS. JAN 31, 1993.
US FDA. GUIDANCE. CVM GFI #53EVALUATION OF THE UTILITY OF FOOD ADDITIVES IN DIET FED TO AQUATIC ANIMALS. APR 30, 1994.
US FDA. GUIDANCE. CVM GFI #55 SUPPORTIVE DATA FOR CAT FOOD LABELS BEARING "REDUCES URINARY PH CLAIMS: PROTOCOL DEVELOPMENT. MAY 31, 1994.
US FDA. GUIDANCE. CVM GFI #56 PROTOCOL DEVELOPMENT GUIDELINE FOR CLINICAL EFFECTIVENESS AND TARGET ANIMAL SAFETY TRIALS. JUL 10, 2001.
US FDA. GUIDANCE. CVM GFI #57 PREPARATION AND SUBMISSION OF VETERINARY MASTER FILES. JAN 01, 1995.
US FDA. GUIDANCE. CVM GFI #63 (VICH GL1) VALIDATION OF ANALYTICAL PROCEDURES: DEFINITION AND TERMINOLOGY. JUL 01, 1999.
US FDA. GUIDANCE. CVM GFI #64 (VICHGL2) VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY. JUL 01, 1999.
US FDA. GUIDANCE. CVM GFI #67 SMALL ENTITIES COMPLIANCE GUIDE FOR RENDERERS. FEB 01, 1998.
US FDA. GUIDANCE. CVM GFI #68 SMALL ENTITIES COMPLIANCE GUIDE FOR PROTEIN BLENDERS, FEED MANUFACTURERS, AND DISTRIBUTORS. FEB 01, 1998.
US FDA. GUIDANCE. CVM GFI #69 SMALL ENTITIES COMPLIANCE GUIDE FOR FEEDERS OF RUMINANT ANIMALS WITH ON-FARM FEED MIXING OPERATIONS. FEB 01, 1998.
US FDA. GUIDANCE. CVM GFI #72 GMP'S FOR MEDICATED FEED MANUFACTURERS NOT REQUIRED TO REGISTER AND BE LICENSED WITH FDA. MAY 01, 1998.
US FDA. GUIDANCE. CVM GFI #74 (VICH GL4 ) STABILITY TESTING OF NEW VETERINARY DOSAGE FORMS. SEP 01, 1999.
US FDA. GUIDANCE. CVM GFI #75 (VICH GL5) STABILITY TESTING-PHOTOSTABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AND MEDICINAL PRODUCTS. SEP 01, 1999.
US FDA. GUIDANCE. CVM GFI #76 QUESTIONS AND ANSWERS BSE FEED REGULATIONS. JUL 01, 1998.
US FDA. GUIDANCE. CVM GFI #80 EVALUATION THE UTILITY OF ANTI-SALMONELLA CHEMICAL FOOD ADDITIVES. NOV 21, 2002.
US FDA. GUIDANCE. CVM GFI #82 DEVELOPMENT OF SUPPLEMENTAL APPLICATIONS FOR APPROVED NEW ANIMAL DRUGS. OCT 28, 2002.
US FDA. GUIDANCE. CVM GFI #85 (VICH GL9) GOOD CLINICAL PRACTICE. MAY 09, 2001.
US FDA. GUIDANCE. CVM GFI #89 (VICH GL6) EIAS FOR VETERINARY MEDICINAL PRODUCTS - PHASE I. MAR 07, 2001.
US FDA. GUIDANCE. CVM GFI #91 (VICH GL8) STABILITY TESTING FOR MEDICATED PREMIXES. MAR 01, 2000.
US FDA. GUIDANCE. CVM GFI #98 DIOXIN IN ANTI-CAKING AGENTS IN ANIMAL FEED AND FEED INGREDIENTS. APR 12, 2000.
US FDA. GUIDANCE. CVM GFI #99 (VICH GL17) TESTING OF NEW BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS. MAR 26, 2001.
US FDA. GUIDANCE. CYBERSECURITY FOR NETWORKED MEDICAL DEVICES CONTAINING OFF-THE-SHELF (OTS) SOFTWARE. JAN 14, 2005.
US FDA. GUIDANCE. CYTOMEGALOVIRUS IN TRANSPLANTATION : DEVELOPING DRUGS TO TREAT OR PREVENT DISEASE. MAY 2020.
US FDA. GUIDANCE. DAIRY PRODUCTS SEC. 527.300 MICROBIAL CONTAMINANTS & ALKALINE PHOSPHATASE ACTIVITY. .
US FDA. GUIDANCE. DATA ELEMENTS FOR SUBMISSION OF VETERINARY ADVERSE EVENT REPORTS TO THE CENTER FOR VETERINARY MEDICINE. #188. APR 2021.
US FDA. GUIDANCE. DATA INTEGRITY AND COMPLIANCE WITH DRUG CGMP. QUESTIONS AND ANSWERS. DEC 2018.
US FDA. GUIDANCE. DATA RETENTION WHEN SUBJECTS WITHDRAW FROM FDA-REGULATED CLINICAL TRIALS. OCT 2008.
US FDA. GUIDANCE. DE NOVO CLASSIFICATION PROCESS (EVALUATION OF AUTOMATIC CLASS III DESIGNATION). OCT 5, 2021.
US FDA. GUIDANCE. DEAR HEALTH CARE PROVIDER LETTERS : IMPROVING COMMUNICATION OF IMPORTANT SAFETY INFORMATION. FEB 2017.
US FDA. GUIDANCE. DEAR MANUFACTURER LETTER REGARDING CHANGES TO FDA’S ADMINISTRATION OF PROCESS FILINGS (FORMS FDA 2541A AND FDA 2541C) FOR ACIDIFED FOODS AND LOW-ACID CANNED FOODS. JAN 2014.
US FDA. GUIDANCE. DEAR MANUFACTURER LETTER REGARDING FOOD LABELING. JAN 2007.
US FDA. GUIDANCE. DEAR MANUFACTURER LETTER REGARDING FRONT-OF-PACKAGE SYMBOLS. DEC 2008.
US FDA. GUIDANCE. DEAR MANUFACTURER LETTER REGARDING SUGAR FREE CLAIMS. SEP 2007.
US FDA. GUIDANCE. DECIDING WHEN TO SUBMIT A 510(K) FOR A CHANGE TO AN EXISTING DEVICE. OCT 25, 2017.
US FDA. GUIDANCE. DECIDING WHEN TO SUBMIT A 510(K) FOR A SOFTWARE CHANGE TO AN EXISTING DEVICE. OCT 25, 2017.
US FDA. GUIDANCE. DECLARING COLOR ADDITIVES IN ANIMAL FOODS. SMALL ENTITY COMPLIANCE GUIDE. #223. SEP 2013.
US FDA. GUIDANCE. DECORATIVE, NON-CORRECTIVE CONTACT LENSES. NOV 24, 2006.
US FDA. GUIDANCE. DEFINITIONS OF SUSPECT PRODUCT AND ILLEGITIMATE PRODUCT FOR VERIFICATION OBLIGATIONS UNDER THE DRUG SUPPLY CHAIN SECURITY ACT. MAR 2023.
US FDA. GUIDANCE. DELAYED GRAFT FUNCTION IN KIDNEY TRANSPLANTATION : DEVELOPING DRUGS FOR PREVENTION. JUL 2019.
US FDA. GUIDANCE. DEMONSTRATING BIOEQUIVALENCE FOR SOLUBLE POWDER ORAL DOSAGE FORM PRODUCTS AND TYPE A MEDICATED ARTICLES CONTAINING ACTIVE PHARMACEUTICAL INGREDIENTS CONSIDERED TO BE SOLUBLE IN AQUEOUS MEDIA. #171. MAY 2021.
US FDA. GUIDANCE. DEMONSTRATING THE SUBSTANTIAL EQUIVALENCE OF A NEW TOBACCO PRODUCT : RESPONSES TO FREQUENTLY ASKED QUESTIONS (EDITION 3)*. MAR 2023.
US FDA. GUIDANCE. DEMONSTRATION OF COMPARABILITY OF HUMAN BIOLOGICAL PRODUCTS, INCLUDING THERAPEUTIC BIOTECHNOLOGY-DERIVED PRODUCTS. MAR 31, 1996.
US FDA. GUIDANCE. DEMONSTRATION OF THE QUALITY FACTOR REQUIREMENTS UNDER 21 CFR 106.96(I) FOR “ELIGIBLE” INFANT FORMULAS. JUN 2014.
US FDA. GUIDANCE. DENTAL COMPOSITE RESIN DEVICES - PREMARKET NOTIFICATION [510(K)] SUBMISSIONS . OCT 25, 2005.
US FDA. GUIDANCE. DENTAL CURING LIGHTS - PREMARKET NOTIFICATION [510(K)]. MAR 27, 2006.
US FDA. GUIDANCE. DENTAL HANDPIECES - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. MAY 2, 2007.
US FDA. GUIDANCE. DENTURE BASE RESINS - PERFORMANCE CRITERIA FOR SAFETY AND PERFORMANCE BASED PATHWAY. APR 13, 2022.
US FDA. GUIDANCE. DESIGN AND ANALYSIS OF SHEDDING STUDIES FOR VIRUS OR BACTERIA-BASED GENE THERAPY AND ONCOLYTIC PRODUCTS. AUG 2015.
US FDA. GUIDANCE. DESIGN CONSIDERATIONS AND PRE-MARKET SUBMISSION RECOMMENDATIONS FOR INTEROPERABLE MEDICAL DEVICES. SEP 6, 2017.
US FDA. GUIDANCE. DESIGN CONSIDERATIONS FOR DEVICES INTENDED FOR HOME USE. NOV 24, 2014.
US FDA. GUIDANCE. DESIGN CONSIDERATIONS FOR PIVOTAL CLINICAL INVESTIGATIONS FOR MEDICAL DEVICES. NOV 7, 2013.
US FDA. GUIDANCE. DESIGN CONTROL GUIDANCE FOR MEDICAL DEVICE MANUFACTURERS. MAR 11, 1997.
US FDA. GUIDANCE. DESIGNATION OF NEW ANIMAL DRUGS FOR MINOR USES OR MINOR SPECIES. SMALL ENTITIES COMPLIANCE GUIDE. #200. JUL 2014.
US FDA. GUIDANCE. DETERMINATION OF INTENDED USE FOR 510(K) DEVICES - GUIDANCE FOR CDRH STAFF (UPDATE TO K98-1). DEC 02, 2002.
US FDA. GUIDANCE. DETERMINATION OF STATUS AS A QUALIFIED FACILITY UNDER PART 117 : CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD AND PART 507 : FOOD FOR ANIMALS. SEP 2018.
US FDA. GUIDANCE. DETERMINATION OF THE PERIOD COVERED BY A NO-TOBACCO-SALE ORDER AND COMPLIANCE WITH AN ORDER (REVISED). MAR 2023.
US FDA. GUIDANCE. DETERMINING DONOR ELIGIBILITY FOR AUTOLOGOUS DONORS OF BLOOD AND BLOOD COMPONENTS INTENDED SOLELY FOR AUTOLOGOUS USE - COMPLIANCE POLICY. AUG 2016.
US FDA. GUIDANCE. DETERMINING THE EXTENT OF SAFETY DATA COLLECTION NEEDED IN LATE-STAGE PREMARKET AND POSTAPPROVAL CLINICAL INVESTIGATIONS. FEB 2016.
US FDA. GUIDANCE. DETERMINING THE NEED FOR AND CONTENT OF ENVIRONMENTAL ASSESSMENTS FOR GENE THERAPIES, VECTORED VACCINES, AND RELATED RECOMBINANT VIRAL OR MICROBIAL PRODUCTS. MAR 2015.
US FDA. GUIDANCE. DETERMINING THE NUMBER OF EMPLOYEES FOR PURPOSES OF THE “SMALL BUSINESS” DEFINITION IN PARTS 117 AND 507 (CGMP AND PREVENTIVE CONTROLS REGULATIONS FOR HUMAN AND ANIMAL FOOD). JUN 2019.
US FDA. GUIDANCE. DETERMINING WHETHER TO SUBMIT AN ANDA OR A 505(B)(2) APPLICATION. MAY 2019.
US FDA. GUIDANCE. DEVELOPING AND LABELING IN VITRO COMPANION DIAGNOSTIC DEVICES FOR A SPECIFIC GROUP OF ONCOLOGY THERAPEUTIC PRODUCTS. APR 2020.
US FDA. GUIDANCE. DEVELOPING AND RESPONDING TO DEFICIENCIES IN ACCORDANCE WITH THE LEAST BURDENSOME PROVISIONS. OCT 26, 2022.
US FDA. GUIDANCE. DEVELOPING MEDICAL IMAGING DRUG AND BIOLOGICAL PRODUCTS PART 1: CONDUCTING SAFETY ASSESSMENTS. JUN 22, 2004.
US FDA. GUIDANCE. DEVELOPING MEDICAL IMAGING DRUG AND BIOLOGICAL PRODUCTS PART 2: CLINICAL INDICATIONS. JUN 22, 2004.
US FDA. GUIDANCE. DEVELOPING MEDICAL IMAGING DRUG AND BIOLOGICAL PRODUCTS PART 3: DESIGN, ANALYSIS, AND INTERPRETATION OF CLINICAL STUDIES. JUN 22, 2004.
US FDA. GUIDANCE. DEVELOPING TARGETED THERAPIES IN LOW-FREQUENCY MOLECULAR SUBSETS OF A DISEASE. OCT 2018.
US FDA. GUIDANCE. DEVELOPMENT AND LICENSURE OF VACCINES TO PREVENT COVID-19. JUN 2020.
US FDA. GUIDANCE. DEVELOPMENT AND SUBMISSION OF NEAR INFRARED ANALYTICAL PROCEDURES. AUG 2021.
US FDA. GUIDANCE. DEVELOPMENT AND USE OF RISK MINIMIZATION ACTION PLANS. MAR 29, 2005.
US FDA. GUIDANCE. DEVELOPMENT OF ABBREVIATED NEW DRUG APPLICATIONS DURING THE COVID-19 PANDEMIC - QUESTIONS AND ANSWERS. UPDATED : SEP 8, 2021.
US FDA. GUIDANCE. DEVELOPMENT OF ANTI-INFECTIVE DRUG PRODUCTS FOR THE PEDIATRIC POPULATION. DEC 2021.
US FDA. GUIDANCE. DEVELOPMENT OF MONOCLONAL ANTIBODY PRODUCTS TARGETING SARS-COV-2, INCLUDING ADDRESSING THE IMPACT OF EMERGING VARIANTS, DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. FEB 2021.
US FDA. GUIDANCE. DEVELOPMENT OF NEW STEREOISOMERIC DRUGS. MAY 01, 1992.
US FDA. GUIDANCE. DEVIATION REPORTING FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS REGULATED SOLELY UNDER SECTION 361 OF THE PUBLIC HEALTH SERVICE ACT AND 21 CFR PART 1271. SEP 2017.
US FDA. GUIDANCE. DEVICE LABELING GUIDANCE #G91-1 (BLUE BOOK MEMO). MAR 07, 1991.
US FDA. GUIDANCE. DEVICES USED TO PROCESS HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS). JUL 2007.
US FDA. GUIDANCE. DIAGNOSTIC ECG GUIDANCE (INCLUDING NON-ALARMING ST SEGMENT MEASUREMENT). NOV 04, 1998.
US FDA. GUIDANCE. DIETARY SUPPLEMENT LABELING GUIDE. MAR 31, 2005.
US FDA. GUIDANCE. DIRECT FINAL RULE PROCEDURES. NOV 20, 1997.
US FDA. GUIDANCE. DISCLOSURE OF MATERIALS PROVIDED TO ADVISORY COMMITTEES IN CONNECTION WITH OPEN ADVISORY COMMITTEE MEETINGS CONVENED BY THE CENTER FOR DRUG EVALUATION AND RESEARCH BEGINNING ON JANUARY 1, 2000. DEC 22, 1999.
US FDA. GUIDANCE. DISPLAY DEVICES FOR DIAGNOSTIC RADIOLOGY. SEP 28, 2022.
US FDA. GUIDANCE. DISPUTE RESOLUTION PROCEDURES FOR SCIENCE-BASED DECISIONS ON PRODUCTS REGULATED BY THE CENTER FOR VETERINARY MEDICINE (CVM). MAY 2014.
US FDA. GUIDANCE. DISSOLUTION TESTING AND ACCEPTANCE CRITERIA FOR IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORM DRUG PRODUCTS CONTAINING HIGH SOLUBILITY DRUG SUBSTANCES. AUG 2018.
US FDA. GUIDANCE. DISSOLUTION TESTING OF IMMEDIATE RELEASE SOLID ORAL DOSAGE FORMS. AUG 25, 1997.
US FDA. GUIDANCE. DISTINGUISHING LIQUID DIETARY SUPPLEMENTS FROM BEVERAGES. JAN 2014.
US FDA. GUIDANCE. DISTINGUISHING MEDICAL DEVICE RECALLS FROM MEDICAL DEVICE ENHANCEMENTS. OCT 15, 2014.
US FDA. GUIDANCE. DISTRIBUTION OF IN VITRO DIAGNOSTIC PRODUCTS LABELED FOR RESEARCH USE ONLY OR INVESTIGATIONAL USE ONLY. NOV 25, 2013.
US FDA. GUIDANCE. DISTRIBUTOR LABELING FOR NEW ANIMAL DRUGS. APR 2016.
US FDA. GUIDANCE. DOCUMENTING ELECTRONIC DATA FILES AND STATISTICAL ANALYSIS PROGRAMS. #197. NOV 2020.
US FDA. GUIDANCE. DONOR DEFERRAL DUE TO RED BLOOD CELL LOSS DURING COLLECTION OF SOURCE PLASMA BY AUTOMATED PLASMAPHERESIS. DEC 04, 1995.
US FDA. GUIDANCE. DONOR ELIGIBILITY FOR ANIMAL CELLS, TISSSUES, AND CELL- AND TISSUE-BASED PRODUCTS. #254. OCT 2022.
US FDA. GUIDANCE. DONOR SCREENING RECOMMENDATIONS TO REDUCE THE RISK OF TRANSMISSION OF ZIKA VIRUS BY HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS. MAY 2018.
US FDA. GUIDANCE. DONORS OF BLOOD AND BLOOD COMPONENTS : NOTIFICATION OF DONOR DEFERRAL. SMALL ENTITY COMPLIANCE GUIDE. JUN 2011.
US FDA. GUIDANCE. DOSAGE DELIVERY DEVICES FOR ORALLY INGESTED OTC LIQUID DRUG PRODUCTS. MAY 2011.
US FDA. GUIDANCE. DRUG AND DEVICE MANUFACTURER COMMUNICATIONS WITH PAYORS, FORMULARY COMMITTEES, AND SIMILAR ENTITIES. QUESTIONS AND ANSWERS. JUN 2018.
US FDA. GUIDANCE. DRUG MASTER FILES : GUIDELINES. JUN 2014.
US FDA. GUIDANCE. DRUG MASTER FILES FOR BULK ANTIBIOTIC DRUG SUBSTANCES. NOV 29, 1999.
US FDA. GUIDANCE. DRUG PRODUCTS CONTAINING ENSULIZOLE, HYPROMELLOSE, MERADIMATE, OCTINOXATE, AND OCTISALATE — LABELING ENFORCEMENT POLICY. JUN 03, 2003.
US FDA. GUIDANCE. DRUG PRODUCTS, INCLUDING BIOLOGICAL PRODUCTS, THAT CONTAIN NANOMATERIALS. APR 2022.
US FDA. GUIDANCE. DRUG STABILITY GUIDELINES. DEC 9, 2008.
US FDA. GUIDANCE. DRUG STUDY DESIGNS. JAN 01, 1998.
US FDA. GUIDANCE. DRUG SUBSTANCE CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION. AUG 6, 2010.
US FDA. GUIDANCE. DRUG SUPPLY CHAIN SECURITY ACT IMPLEMENTATION : IDENTIFICATION OF SUSPECT PRODUCT AND NOTIFICATION. REV. 1. JUN 2021.
US FDA. GUIDANCE. DRUG-INDUCED LIVER INJURY : PREMARKETING CLINICAL EVLAUATION. JUL 2009.
US FDA. GUIDANCE. DRUGS FOR TREATMENT OF PARTIAL ONSET SEIZURES : FULL EXTRAPOLATION OF EFFICACY FROM ADULTS TO PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER. SEP 2019.
US FDA. GUIDANCE. DSCSA IMPLEMENTATION : PRODUCT TRACING REQUIREMENTS - COMPLIANCE POLICY. DEC 2014.
US FDA. GUIDANCE. DSCSA IMPLEMENTATION : PRODUCT TRACING REQUIREMENTS FOR DISPENSERS - COMPLIANCE POLICY (REVISED). OCT 2015.
US FDA. GUIDANCE. DUCHENNE MUSCULAR DYSTROPHY AND RELATED DYSTROPHINOPATHIES : DEVELOPING DRUGS FOR TREATMENT. FEB 2018.
US FDA. GUIDANCE. E10 CHOICE OF CONTROL GROUP AND RELATED ISSUES IN CLINICAL TRIALS. MAY 14, 2001.
US FDA. GUIDANCE. E11 (R1) ADDENDUM : CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION. APR 2018.
US FDA. GUIDANCE. E11 CLINICAL INVESTIGATION OF MEDICINAL PRODUCTS IN THE PEDIATRIC POPULATION. DEC 15, 2000.
US FDA. GUIDANCE. E14 AND S7B CLINICAL AND NONCLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRYTHMIC POTENTIAL - QUESTIONS AND ANSWERS. AUG 2022.
US FDA. GUIDANCE. E14 CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTI-ARRHYTHMIC DRUGS - QUESTIONS AND ANSWERS (R3). JUN 2017. REV. 2.
US FDA. GUIDANCE. E14 CLINICAL EVALUATION OF QT/QTC INTERVAL PROLONGATION AND PROARRHYTHMIC POTENTIAL FOR NON-ANTIARRHYTHMIC DRUGS. OCT 2005.
US FDA. GUIDANCE. E15 DEFINITIONS FOR GENOMIC BIOMARKERS, PHARMACOGENOMICS, PHARMACOGENETICS, GENOMIC DATA AND SAMPLE CODING CATEGORIES. APR 2008.
US FDA. GUIDANCE. E16 BIOMARKERS RELATED TO DRUG OR BIOTECHNOLOGY PRODUCT DEVELOMENT : CONTEXT, STRUCTURE, AND FORMAT OF QUALIFICATION SUBMISSIONS. AUG 2011.
US FDA. GUIDANCE. E17 GENERAL PRINCIPLES FOR PLANNING AND DESIGN OF MULTIREGIONAL CLINICAL TRIALS. JUL 2018.
US FDA. GUIDANCE. E18 GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA. MAR 2018.
US FDA. GUIDANCE. E1A THE EXTENT OF POPULATION EXPOSURE TO ASSESS CLINICAL SAFETY: FOR DRUGS INTENDED FOR LONG-TERM TREATMENT OF NON-LIFE-THREATENING CONDITIONS. MAR 01, 1995.
US FDA. GUIDANCE. E2A CLINICAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING. MAR 01, 1995.
US FDA. GUIDANCE. E2B(M) : DATA ELEMENTS FOR TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS. QUESTIONS AND ANSWERS. MAR 09, 2005.
US FDA. GUIDANCE. E2B(R3) ELECTRONIC TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS (ICSRS) IMPLEMENTATION GUIDE - DATA ELEMENTS AND MESSAGE SPECIFICATION. APR 2022. REV. 1.
US FDA. GUIDANCE. E2B(R3) ELECTRONIC TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS IMPLEMENTATION GUIDE - DATA ELEMENTS AND MESSAGE SPECIFICATION; AND APPENDIX TO THE IMPLEMENTATION GUIDE - BACKWARDS AND FORWARDS COMPATIBILITY
US FDA. GUIDANCE. E2BM DATA ELEMENTS FOR TRANSMISSION OF INDIVIDUAL CASE SAFETY REPORTS. APR 04, 2002.
US FDA. GUIDANCE. E2C(R2) PERIODIC BENEFIT-RISK EVALUATION REPORT (PBRER). JUL 2016. REV. 1.
US FDA. GUIDANCE. E2C(R2) PERIODIC BENEFIT-RISK EVALUATION REPORT. QUESTIONS AND ANSWERS. JUL 2016.
US FDA. GUIDANCE. E2D POSTAPPROVAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING. SEP 12, 2003.
US FDA. GUIDANCE. E2E PHARMACOVIGILANCE PLANNING. APR 01, 2005.
US FDA. GUIDANCE. E2F DEVELOPMENT SAFETY UPDATE REPORT. AUG 2011.
US FDA. GUIDANCE. E3 STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS. JUL 01, 1996.
US FDA. GUIDANCE. E3 STRUCTURE AND CONTENT OF CLINICAL STUDY REPORTS. QUESTIONS AND ANSWERS (R1). JAN 2013.
US FDA. GUIDANCE. E4 DOSE-RESPONSE INFORMATION TO SUPPORT DRUG REGISTRATION. JUL 01, 1996.
US FDA. GUIDANCE. E5 ETHNIC FACTORS IN THE ACCEPTABILITY OF FOREIGN CLINICAL DATA. JUN 10, 1998.
US FDA. GUIDANCE. E6(R2) GOOD CLINICAL PRACTICE : INTEGRATED ADDENDUM TO ICH E6(R1). MAR 2018.
US FDA. GUIDANCE. E7 STUDIES IN SUPPORT OF SPECIAL POPULATIONS : GERIATRICS. QUESTIONS AND ANSWERS. FEB 2012.
US FDA. GUIDANCE. E7 STUDIES IN SUPPORT OF SPECIAL POPULATIONS: GERIATRICS. AUG 01, 1994.
US FDA. GUIDANCE. E8 GENERAL CONSIDERATIONS FOR CLINICAL TRIALS. DEC 17, 1997.
US FDA. GUIDANCE. E8(R1) GENERAL CONSIDERATIONS FOR CLINICAL STUDIES. APR 2022. REV. 1.
US FDA. GUIDANCE. E9 STATISTICAL PRINCIPLES FOR CLINICAL TRIALS. SEP 16, 1998.
US FDA. GUIDANCE. E9(R1) STATISTICAL PRINCIPLES FOR CLINICAL TRIALS: ADDENDUM: ESTIMANDS AND SENSITIVITY ANALYSIS IN CLINICAL TRIALS. MAY 2021. REV. 1.
US FDA. GUIDANCE. EARLY CLINICAL TRIALS WITH LIVE BIOTHERAPEUTIC PRODUCTS : CHEMISTRY, MANUFACTURING, AND CONTROL INFORMATION. JUN 2016.
US FDA. GUIDANCE. EARLY COLLABORATION MEETINGS UNDER THE FDA MODERNIZATION ACT (FDAMA).. FEB 27, 2001.
US FDA. GUIDANCE. EARLY DEVELOPMENT CONSIDERATIONS FOR INNOVATIVE COMBINATION PRODUCTS AND FDA STAFF. SEP 01, 2006.
US FDA. GUIDANCE. ECOPY PROGRAM FOR MEDICAL DEVICE SUBMISSIONS. APR 27, 2020.
US FDA. GUIDANCE. ECTD TECHNICAL CONFORMANCE GUIDE. TECHNICAL SPECIFICATIONS DOCUMENT. OCT 2021.
US FDA. GUIDANCE. EFFECTIVE VISUAL CONTROL OF LASER PROJECTIONS (LASER NOTICE 47). JUN 06, 1996.
US FDA. GUIDANCE. EFFECTS OF THE COVID-19 PUBLIC HEALTH EMERGENCY ON FORMAL MEETINGS AND USER FEE APPLICATIONS. QUESTIONS AND ANSWERS. MAY 2020.
US FDA. GUIDANCE. EFFICACY STUDIES TO SUPPORT MARKETING OF FIBRIN SEALANT PRODUCTS MANUFACTURED FOR COMMERCIAL USE. MAY 20, 1999.
US FDA. GUIDANCE. ELECTROMAGNETIC COMPATABILITY OF MEDICAL DEVICES (EMC). JUN 6, 2022.
US FDA. GUIDANCE. ELECTRONIC DRUG PRODUCT REPORTING FOR HUMAN DRUG COMPOUNDING OUTSOURCING FACILTIIES UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. DEC 2016.
US FDA. GUIDANCE. ELECTRONIC EXCHANGE OF DOCUMENTS. ELECTRONIC FILE FORMAT. VICH GL53. #225. SEP 2015.
US FDA. GUIDANCE. ELECTRONIC SOURCE DATA IN CLINICAL INVESTIGATIONS. SEP 2013.
US FDA. GUIDANCE. ELECTRONIC SUBMISSION OF LOT DISTRIBUTION REPORTS. MAR 2015.
US FDA. GUIDANCE. ELECTRONIC SUBMISSION TEMPLATE FOR MEDICAL DEVICE 510(K) SUBMISSIONS. SEP 22, 2022.
US FDA. GUIDANCE. ELEMENTAL IMPURITIES IN ANIMAL DRUG PRODUCTS. QUESTIONS AND ANSWERS. #255. NOV 2020.
US FDA. GUIDANCE. ELEMENTAL IMPURITIES IN DRUG PRODUCTS. AUG 2018.
US FDA. GUIDANCE. ELIGIBILITY CRITERIA FOR EXPANDED CONDITIONAL APPROVAL OF NEW ANIMAL DRUGS. #261. JUL 2021.
US FDA. GUIDANCE. ELIGIBILITY DETERMINATION FOR DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS). AUG 2007.
US FDA. GUIDANCE. EMERGENCY USE AUTHORIZATION FOR VACCINES TO PREVENT COVID-19. MAR 31, 2022.
US FDA. GUIDANCE. EMERGENCY USE OF AN INVESTIGATIONAL DRUG OR BIOLOGIC. JAN 01, 1998.
US FDA. GUIDANCE. EMITTED LASER BEAM AS EMISSION INDICATOR FOR CLASS II AND CLASS IIIA LASER PRODUCTS (LASER NOTICE 49). SEP 05, 1996.
US FDA. GUIDANCE. END-OF-PHASE 2A MEETINGS. SEP 2009.
US FDA. GUIDANCE. ENDOTOXIN TESTING RECOMMENDATIONS FOR SINGLE-USE INTRAOCULAR OPHTHALMIC DEVICES. AUG 17, 2015.
US FDA. GUIDANCE. ENFORCEMENT POLICY CONCERNING CERTAIN REGULATIONS RESTRICTING THE SALE AND DISTRIBUTION OF CIGARETTES AND SMOKELESS TOBACCO. MAY 7, 2010.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR CERTAIN (PROVISIONAL) TOBACCO PRODUCTS THAT FDA FINDS NOT SUBSTANTIALLY EQUIVALENT. SEP 2015.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR CLINICAL ELECTRONIC THERMOMETERS DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR DIGITAL HEALTH DEVICES FOR TREATING PSYCHIATRIC DISORDERS DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR EXTRACORPOREAL MEMBRANE OXYGENATION AND CARDIOPULMONARY BYPASS DEVICES DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR FACE MASKS AND BARRIER FACE COVERINGS DURING THE CORONAVIRUS DISEASE (COVID-19) PUBLIC HEALTH EMERGENCY. MAR 13, 2023.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR FACE SHIELDS, SURGICAL MASKS, AND RESPIRATORS DURING THE CORONAVIRUS DISEASE (COVID-19) PUBLIC HEALTH EMERGENCY. MAR 13, 2023.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR GOWNS, OTHER APPAREL, AND GLOVES DURING THE CORONAVIRUS DISEASE (COVID-19) PUBLIC HEALTH EMERGENCY. MAR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR IMAGING SYSTEMS DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR INFUSION PUMPS AND ACCESSORIES DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR MODIFICATIONS TO FDA-CLEARED MOLECULAR INFLUENZA AND RSV TESTS DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. OCT 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR NON-INVASIVE FETAL AND MATERNAL MONITORING DEVICES USE TO SUPPORT PATIENT MONITORING DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR NON-INVASIVE REMOTE MONITORING DEVICES USED TO SUPPORT PATIENT MONITORING DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY (REVISED). OCT 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR OPHTHALMIC ASSESSMENT AND MONITORING DEVICES DURING THE CORNAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR PROVIDING AN ACCEPTABLE UNIQUE FACILITY IDENTIFIER (UFI) FOR THE 2020 FOOD FACILITY REGISTRATION BIENNIAL RENEWAL PERIOD. MAR 2021.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR REMOTE DIGITAL PATHOLOGY DEVICES DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR STERILIZERS, DISINFECTANT DEVICES, AND AIR PURIFIERS DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. MAR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR TELETHERMOGRAPHIC SYSTEMS DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR THE QUALITY STANDARDS OF THE MAMMOGRAPHY QUALITY STANDARDS ACT DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. DEC 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR VENTILATORS AND ACCESSORIES AND OTHER RESPIRATORY DEVICES DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. MAR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY FOR VIRAL TRANSPORT MEDIA DURING THE CORONAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY (REVISED). NOV 2021.
US FDA. GUIDANCE. ENFORCEMENT POLICY ON MARKETING OTC COMBINATION PRODUCTS (CPG 7132B.16).. MAY 01, 1984.
US FDA. GUIDANCE. ENFORCEMENT POLICY REGARDING FEDERAL VCPR REQUIREMENTS TO FACILITATE VETERINARY TELEMEDICINE DURING THE COVID-19 OUTBREAK. MAR 2020.
US FDA. GUIDANCE. ENFORCEMENT POLICY REGARDING INVESTIGATIONAL NEW DRUG REQUIREMENTS FOR USE OF FECAL MICROBIOTA FOR TRANSPLANTATION TO TREAT CLOSTRIDIUM DIFFICILE INFECTION NOT RESPONSIVE TO STANDARD THERAPIES. NOV 2022.
US FDA. GUIDANCE. ENFORCEMENT POLICY REGARDING USE OF NATIONAL HEALTH RELATED ITEM CODE AND NATIONAL DRUG CODE NUMBERS ON DEVICE LABELS AND PACKAGES. MAY 21, 2021.
US FDA. GUIDANCE. ENFORCEMENT PRIORITIES FOR ELECTRONIC NICOTINE DELIVERY SYSTEMS (ENDS) AND OTHER DEEMED PRODUCTS ON THE MARKET WITHOUT PREMARKET AUTHORIZATION. APR 2020. REVISED.
US FDA. GUIDANCE. ENHANCING THE DIVERSITY OF CLINICAL TRIAL POPULATIONS - ELIGIBILITY CRITERIA, ENROLLMENT PRACTICES, AND TRIAL DESIGNS. NOV 2020.
US FDA. GUIDANCE. ENRICHMENT STRATEGIES FOR CLINICAL TRIALS TO SUPPORT DETERMINATION OF EFFECTIVENESS OF HUMAN DRUGS AND BIOLOGICAL PRODUCTS. MAR 2019.
US FDA. GUIDANCE. ENSURING SAFETY OF ANIMAL FEED MAINTAINED AND FED ON-FARM. #203. MAR 2016.
US FDA. GUIDANCE. ENTRY TYPES AND ENTRY IDENTIFIERS IN PRIOR NOTICE OF IMPORTED FOOD. APR 07, 2005.
US FDA. GUIDANCE. ENVIRONMENTAL ASSESSMENT : QUESTIONS AND ANSWERS REGARDING DRUGS WITH ESTROGENIC, ANDROGENIC, OR THYROID ACTIVITY. MAR 2016.
US FDA. GUIDANCE. ENVIRONMENTAL ASSESSMENT OF HUMAN DRUG AND BIOLOGICS APPLICATIONS. JUL 27, 1998.
US FDA. GUIDANCE. ENZYME PREPARATIONS : RECOMMENDATIONS FOR SUBMISSION OF CHEMICAL AND TECHNOLOGICAL DATA FOR FOOD ADDITIVE PETITIONS AND GRAS NOTICES. JUL 2010.
US FDA. GUIDANCE. EOSINOPHILIC ESOPHAGITIS. DEVELOPING DRUGS FOR TREATMENT. SEP 2020.
US FDA. GUIDANCE. EPIDERMOLYSIS BULLOSA : DEVELOPING DRUGS FOR TREATMENT OF CUTANEOUS MANIFESTATIONS. JUN 2019.
US FDA. GUIDANCE. ESTABLISHING AND MAINTAINING A LIST OF U.S. DAIRY PRODUCT MANUFACTURERS / PROCESSORS WITH INTEREST IN EXPORTING TO CHILE. NOV 2018.
US FDA. GUIDANCE. ESTABLISHING AND MAINTAINING A LIST OF U.S. MILK AND MILK PRODUCT, SEAFOOD, INFANT FORMULA, AND FORMULA FOR YOUNG CHILDREN MANUFACTURERS / PROCESSORS WITH INTEREST IN EXPORTING TO CHINA. NOV 2018.
US FDA. GUIDANCE. ESTABLISHING EFFECTIVENESS FOR DRUGS INTENDED TO TREAT MALE HYPOGONADOTROPIC HYPOGONADISM ATTRIBUTED TO NONSTRUCTURAL DISORDERS. MAY 2018.
US FDA. GUIDANCE. ESTABLISHING THAT A TOBACCO PRODUCT WAS COMMERCIALLY MARKETED IN THE UNITED STATES AS OF FEBRUARY 15, 2007. SEP 2014.
US FDA. GUIDANCE. ESTABLISHING THE PERFORMANCE CHARACTERISTICS OF IN VITRO DIAGNOSTIC DEVICES FOR THE DETECTION OF ANTIBODIES TO BORRELIA BURGDORFERI. MAR 28, 2013.
US FDA. GUIDANCE. ESTABLISHING THE PERFORMANCE CHARACTERISTICS OF IN VITRO DIAGNOSTIC DEVICES FOR THE DETECTION OR DETECTION AND DIFFERENTIATION OF HUMAN PAPILLOMAVIRUSES. SEP 15, 2017.
US FDA. GUIDANCE. ESTABLISHING THE PERFORMANCE CHARACTERISTICS OF IN VITRO DIAGNOSTIC DEVICES FOR THE DETECTION OR DETECTION AND DIFFERENTIATION OF INLUFENZA VIRUSES. JUL 15, 2011.
US FDA. GUIDANCE. ESTABLISHMENT AND OPERATION OF CLINICAL TRIAL DATA MONITORING COMMITTEES. MAR 28, 2006.
US FDA. GUIDANCE. ESTIMATING DIETARY INTAKE OF SUBSTANCES IN FOOD. AUG 01, 2006.
US FDA. GUIDANCE. ESTIMATING THE MAXIMUM SAFE STARTING DOSE IN INITIAL CLINICAL TRIALS FOR THERAPEUTICS IN ADULT HEALTHY VOLUNTEERS. JUL 28, 2005.
US FDA. GUIDANCE. EVALUATING CANCER DRUGS IN PATIENTS WITH CENTRAL NERVOUS SYSTEM METASTASES. JUL 2021.
US FDA. GUIDANCE. EVALUATING DRUG EFFECTS ON THE ABILITY TO OPERATE A MOTOR VEHICLE. NOV 2017.
US FDA. GUIDANCE. EVALUATING THE EFFECTIVENESS OF ANTICOCCIDIAL DRUGS IN FOOD-PRODUCING ANIMALS. #217. NOV 2012.
US FDA. GUIDANCE. EVALUATING THE EFFECTIVENESS OF NEW ANIMAL DRUGS FOR THE REDUCTION OF PATHOGENIC SHIGA TOXIN-PRODUCING E. COLI IN CATTLE. #229. OCT 2015.
US FDA. GUIDANCE. EVALUATING THE RISKS OF DRUG EXPOSURE IN HUMAN PREGNANCIES. APR 27, 2005.
US FDA. GUIDANCE. EVALUATING THE SAFETY OF FLOOD-AFFECTED FOOD CROPS FOR HUMAN CONSUMPTION. OCT 2011.
US FDA. GUIDANCE. EVALUATION AND REPORTING OF AGE-, RACE-, AND ETHNICITY-SPECIFIC DATA IN MEDICAL DEVICE CLINICAL STUDIES. SEP 12, 2017.
US FDA. GUIDANCE. EVALUATION OF BULK DRUG SUBSTANCES NOMINATED FOR USE IN COMPOUNDING UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. MAR 2019.
US FDA. GUIDANCE. EVALUATION OF DEVICES USED WITH REGENERATIVE MEDICINE ADVANCED THERAPIES. FEB 2019.
US FDA. GUIDANCE. EVALUATION OF GASTRIC PH-DEPENDENT DRUG INTERACTIONS WITH ACID-REDUCING AGENTS : STUDY DESIGN, DATA ANALYSIS, AND CLINICAL IMPLICATIONS. MAR 2023.
US FDA. GUIDANCE. EVALUATION OF GENDER DIFFERENCES IN CLINICAL INVESTIGATIONS. JAN 01, 1998.
US FDA. GUIDANCE. EVALUATION OF INTERNAL STANDARD RESPONSES DURING CHROMATOGRAPHIC BIOANALYSIS : QUESTIONS AND ANSWERS. SEP 2019.
US FDA. GUIDANCE. EVALUATION OF SEX-SPECIFIC DATA IN MEDICAL DEVICE CLINICAL STUDIES. AUG 22, 2014.
US FDA. GUIDANCE. EVIDENCE-BASED REVIEW SYSTEM FOR THE SCIENTIFIC EVALUATION OF HEALTH CLAIMS. JAN 2009.
US FDA. GUIDANCE. EXCEPTION FROM INFORMED CONSENT REQUIREMENTS FOR EMERGENCY RESEARCH. APR 2013.
US FDA. GUIDANCE. EXEMPT INFANT FORMULA PRODUCTION : CURRENT GOOD MANUFACTURING PRACTICES (CGMPS), QUALITY CONTROL PROCEDURES, CONDUCT OF AUDITS, AND RECORDS AND REPORTS. APR 2016.
US FDA. GUIDANCE. EXEMPTION AND EXCLUSION FROM CERTAIN REQUIREMENT OF THE DRUG SUPPLY CHAIN SECURITY ACT DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. EXEMPTION AND EXCLUSION FROM CERTAIN REQUIREMENTS OF THE DRUG SUPPLY CHAIN SECURITY ACT FOR THE DISTRIBUTION OF FDA-APPROVED NALOXONE PRODUCTS DURING THE OPIOID PUBLIC HEALTH EMERGENCY. SEP 2022.
US FDA. GUIDANCE. EXEMPTION FROM CERTAIN REPORTING AND RECORDKEEPING REQUIREMENTS FOR MICROWAVE OVENS. OCT 20, 2006.
US FDA. GUIDANCE. EXEMPTION FROM CERTAIN REPORTING AND RECORDKEEPING REQUIREMENTS FOR TELEVISION RECEIVERS AND COMPUTER MONITORS WITH CATHODE RAY TUBES. OCT 19, 2006.
US FDA. GUIDANCE. EXEMPTION FROM REPORTING AND RECORD KEEPING REQUIREMENTS FOR CERTAIN SUNLAMP PRODUCT MANUFACTURERS. SEP 16, 1981.
US FDA. GUIDANCE. EXEMPTION FROM REPORTING AND RECORDKEEPING REQUIREMENTS FOR LOW POWER LASER PRODUCTS (LASER NOTICE 54). JAN 05, 2006.
US FDA. GUIDANCE. EXEMPTION OF CERTAIN LASERS USED BY DOE, NOAA AND U.S. DEPT. OF COMMERCE (LASER NOTICE 25). SEP 14, 1979.
US FDA. GUIDANCE. EXEMPTIONS FROM THE WARNING LABEL REQUIREMENT FOR JUICE. OCT 07, 2002.
US FDA. GUIDANCE. EXPANSION COHORTS : USE IN FIRST-IN-HUMAN CLINICAL TRIALS TO EXPEDITE DEVELOPMENT OF ONCOLOGY DRUGS AND BIOLOGICS. MAR 2022.
US FDA. GUIDANCE. EXPEDITED PROGRAMS FOR REGENERATIVE MEDICINE THERAPIES FOR SERIOUS CONDITIONS. FEB 2019.
US FDA. GUIDANCE. EXPEDITED PROGRAMS FOR SERIOUS CONDITIONS - DRUGS AND BIOLOGICS. MAY 2014.
US FDA. GUIDANCE. EXPIRATION DATING AND STABILITY TESTING OF SOLID ORAL DOSAGE FORM DRUGS CONTAINING IRON. JUL 09, 1997.
US FDA. GUIDANCE. EXPIRATION DATING OF UNIT-DOSE REPACKAGED SOLID ORAL DOSAGE FORM DRUG PRODUCTS. JUL 2020.
US FDA. GUIDANCE. EXPLORATORY IND STUDIES. JAN 12, 2006.
US FDA. GUIDANCE. EXPORTS UNDER THE FDA EXPORT REFORM AND ENHANCEMENT ACT OF 1996 . DEC 01, 1996.
US FDA. GUIDANCE. EXPOSURE-RESPONSE RELATIONSHIPS — STUDY DESIGN, DATA ANALYSIS, AND REGULATORY APPLICATIONS. MAY 05, 2003.
US FDA. GUIDANCE. EXTENDED RELEASE ORAL DOSAGE FORMS: DEVELOPMENT, EVALUATION, AND APPLICATION OF IN VITRO/IN VIVO CORRELATIONS. SEP 01, 1997.
US FDA. GUIDANCE. EXTENDING EXPIRATION DATES OF DOXYCYCLINE TABLETS AND CAPSULES IN STRATEGIC STOCKPILES. APR 2019.
US FDA. GUIDANCE. FACET SCREW SYSTEMS - PERFORMANCE CRITERIA FOR SAFETY AND PERFORMANCE BASED PATHWAY. APR 13, 2022.
US FDA. GUIDANCE. FACILITY DEFINITION UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. MAY 2018.
US FDA. GUIDANCE. FACTORS TO CONSIDER WHEN MAKING BENEFIT-RISK DETERMINATIONS FOR MEDICAL DEVICE INVESTIGATIONAL DEVICE EXEMPTIONS. JAN 13, 2017.
US FDA. GUIDANCE. FACTORS TO CONSIDER WHEN MAKING BENEFIT-RISK DETERMINATIONS IN MEDICAL DEVICE PREMARKET APPROVAL AND DE NOVO CLASSIFICATIONS. AUG 2019.
US FDA. GUIDANCE. FAILURE TO RESPOND TO AN ANDA COMPLETE RESPONSE LETTER WITHIN THE REGULATORY TIMEFRAME. DEC 2022. REV. 1.
US FDA. GUIDANCE. FDA ACCEPTANCE OF FOREIGN CLINICAL STUDIES NOT CONDUCTED UNDER AN IND. FREQUENTLY ASKED QUESTIONS. MAR 2012.
US FDA. GUIDANCE. FDA AND INDUSTRY ACTIONS ON DE NOVO CLASSIFICATION REQUESTS : EFFECT ON FDA REVIEW CLOCK AND GOALS. OCT 3, 2022.
US FDA. GUIDANCE. FDA AND INDUSTRY ACTIONS ON PREMARKET APPROVAL APPLICATIONS (PMAS) : EFFECT ON FDA REVIEW CLOCK AND GOALS. OCT 3, 2022.
US FDA. GUIDANCE. FDA AND INDUSTRY ACTIONS ON PREMARKET NOTIFICATION (510(K)) SUBMISSIONS : EFFECT ON FDA REVIEW CLOCK AND GOALS. OCT 3, 2022.
US FDA. GUIDANCE. FDA AND INDUSTRY PROCEDURES FOR SECTION 513(G) REQUESTS FOR INFORMATION UNDER THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. DEC 16, 2019.
US FDA. GUIDANCE. FDA ANIMAL PRODUCTS DATABASE DATA ENTRY FORM. NOV 06, 1998.
US FDA. GUIDANCE. FDA APPROVAL OF NEW CANCER TREATMENT USES FOR MARKETED DRUG AND BIOLOGICAL PRODUCTS. DEC 01, 1998.
US FDA. GUIDANCE. FDA CATEGORIZATION OF INVESTIGATIONAL DEVICE EXEMPTION (IDE) DEVICES TO ASSIST THE CENTERS FOR MEDICARE AND MEDICAID SERVICES (CMS) WITH COVERAGE DECISIONS. DEC 5, 2017.
US FDA. GUIDANCE. FDA DEEMS CERTAIN TOBACCO PRODUCTS SUBJECT TO FDA AUTHORITY, SALES AND DISTRIBUTION RESTRICTIONS, AND HEALTH WARNING REQUIREMENTS FOR PACKAGES AND ADVERTISEMENTS (REVISED)*. SMALL ENTITY COMPLIANCE GUIDE. MAR 2023.
US FDA. GUIDANCE. FDA GUIDANCE DOCUMENT CONCERNING USE OF PILOT MANUFACTURING FACILITIES FOR THE DEVELOPMENT AND MANUFACTURE OF BIOLOGICAL PRODUCTS.. JUL 11, 1995.
US FDA. GUIDANCE. FDA OVERSIGHT OF FOOD PRODUCTS COVERED BY SYSTEMS RECOGNITION ARRANGEMENTS. JUN 2022.
US FDA. GUIDANCE. FDA OVERSIGHT OF PET DRUG PRODUCTS. QUESTIONS AND ANSWERS. DEC 2012.
US FDA. GUIDANCE. FDA RECOMMENDATIONS CONCERNING TESTING FOR ANTIBODY TO HEPATITIS B CORE ANTIGEN (ANTI-HBC). SEP 10, 1991.
US FDA. GUIDANCE. FDA REQUIREMENTS FOR APPROVAL OF DRUGS TO TREAT NON-SMALL CELL LUNG CANCER. MAR 02, 1998.
US FDA. GUIDANCE. FDA REVIEW OF VACCINE LABELING REQUIREMENTS FOR WARNINGS, USE INSTRUCTIONS, AND PRECAUTIONARY INFORMATION. OCT 01, 2004.
US FDA. GUIDANCE. FDA'S IMPLEMENTATION OF QUALIFIED HEALTH CLAIMS. MAY 12, 2006.
US FDA. GUIDANCE. FDA’S STRATEGY ON ANTIMICROBIAL RESISTANCE - QUESTIONS AND ANSWERS. DEC 2013.
US FDA. GUIDANCE. FDARA IMPLEMENTATION GUIDANCE FOR PEDIATRIC STUDIES OF MOLECULARLY TARGETED ONCOLOGY DRUGS : AMENDMENTS TO SEC. 505B OF THE FD&C ACT. MAY 2021.
US FDA. GUIDANCE. FEASIBILITY AND EARLY FEASIBILITY CLINICAL STUDIES FOR CERTAIN MEDICAL DEVICES INTENDED TO THERAPEUTICALLY IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS. MAY 6, 2022.
US FDA. GUIDANCE. FEES FOR HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES UNDER SECTIONS 503B AND 744K OF THE FD&C ACT. APR 2, 2020.
US FDA. GUIDANCE. FEES-EXCEED-THE-COSTS WAIVERS UNDER THE PRESCRIPTION DRUG USER FEE ACT. JUN 01, 1999.
US FDA. GUIDANCE. FIELD ALERT REPORT SUBMISSION - QUESTIONS AND ANSWERS. JUL 2021.
US FDA. GUIDANCE. FINAL IN VIVO BIOAVAILABILITY-BIOEQUIVALENCE STUDIES ANALYTICAL. MAY 1, 2018.
US FDA. GUIDANCE. FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS. FEB 2013.
US FDA. GUIDANCE. FISH AND FISHERY PRODUCTS. HAZARDS AND CONTROLS GUIDANCE. SGR 129. JUL 2022.
US FDA. GUIDANCE. FIXED DOSE COMBINATIONS, CO-PACKAGED DRUG PRODUCTS, AND SINGLE-ENTITY VERSIONS OF PREVIOUSLY APPROVED ANTIRETROVIRALS FOR THE TREATMENT OF HIV. OCT 17, 2006.
US FDA. GUIDANCE. FOOD ADDITIVE PETITION EXPEDITED REVIEW. OCT 2010.
US FDA. GUIDANCE. FOOD ALLERGEN LABELING EXEMPTION PETITION AND NOTIFICATIONS. JUN 2015.
US FDA. GUIDANCE. FOOD LABELING : NUTRIENT CONTENT CLAIMS, ALPHA-LINOLENIC ACID, EICOSAPENTAENOIC ACID, AND DOCOSAHEXAENOIC ACID OMEGA-3 FATTY ACIDS. SMALL ENTITY COMPLIANCE GUIDE. FEB 2016.
US FDA. GUIDANCE. FOOD LABELING : SERVING SIZES OF FOODS THAT CAN BE REASONABLY BE CONSUMED AT ONE EATIN OCCASION, REFERENCE AMOUNTS CUSTOMARILY CONSUMED, SERVING SIZE-RELATED ISSUES, DUAL-COLUMN LABELING, AND MISCELLANEOUS TOPICS. DEC 2019.
US FDA. GUIDANCE. FOOD LABELING : SERVING SIZES OF FOODS THAT CAN REASONABLY BE CONSUMED AT ONE EATING OCCASION, DUAL-COLUMN LABELING, UPDATING, MODIFYING, AND ESTABOLISHING CERTAINR EEFERENCE AMOUNTS CUSTOMARILY CONSUMED, SERVING SIZE FOR BREATH MINTS, AND TECHNICAL AMENDMENTS. SMALL ENTITY COMPLIANCE GUIDE. FEB 2018.
US FDA. GUIDANCE. FOOD SECURITY PREVENTIVE MEASURES GUIDANCE FOR DAIRY FARMS, BULK MILK TRANSPORTERS, BULK MILK TRANSFER STATIONS AND FLUID MILK PROCESSORS. OCT 2007.
US FDA. GUIDANCE. FOOD SECURITY PREVENTIVE MEASURES GUIDANCE FOR RETAIL FOOD STORES AND FOOD SERVICE ESTABLISHMENTS. OCT 2007.
US FDA. GUIDANCE. FOOD-EFFECT BIOAVAILABILITY AND FED BIOEQUIVALENCE STUDIES. DEC 01, 2002.
US FDA. GUIDANCE. FOR ENTITIES CONSIDERING WHETHER TO REGISTER AS OUTSOURCING FACILITIES UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. AUG 2015.
US FDA. GUIDANCE. FOR RENDERERS - SUBSTANCES PROHIBITED FROM USE IN ANIMAL FOOD OR FEED. #195. MAY 6, 2009.
US FDA. GUIDANCE. FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING AND CONTROLS AND ESTABLISHMENT DESCRIPTION INFORMATION FOR HUMAN BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION OR FOR FURTHER MANUFACTURE AND FOR THE COMPLETION OF THE FORM FDA 356H. MAY 10, 1999.
US FDA. GUIDANCE. FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING AND CONTROLS AND ESTABLISHMENT DESCRIPTION INFORMATION FOR HUMAN PLASMA-DERIVED BIOLOGICAL PRODUCTS, ANIMAL PLASMA OR SERUM-DERIVED PRODUCTS:. FEB 17, 1999.
US FDA. GUIDANCE. FOREIGN SUPPLIER VERIFICATION PROGRAMS FOR IMPORTERS OF FOOD FOR HUMANS AND ANIMALS : WHAT YOU NEED TO KNOW ABOUT THE FDA REGULATION. SMALL ENTITY COMPLIANCE GUIDE. JAN 2018.
US FDA. GUIDANCE. FOREIGN SUPPLIER VERIFICATION PROGRAMS FOR IMPORTERS OF FOOD FOR HUMANS AND ANIMALS. JAN 2023.
US FDA. GUIDANCE. FORM FDA 3674 - CERTIFICATIONS TO ACCOMPANY DRUG, BIOLOGICAL PRODUCT, AND DEVICE APPLICATIONS / SUBMISSIONS. JUN 2017.
US FDA. GUIDANCE. FORMAL DISPUTE RESOLUTION : SPONSOR APPEALS ABOVE THE DIVISION LEVEL. NOV 2017.
US FDA. GUIDANCE. FORMAL DISPUTE RESOLUTION: SCIENTIFIC AND TECHNICAL ISSUES RELATED TO PHARMACEUTICAL CGMP_PRA. JAN 11, 2006.
US FDA. GUIDANCE. FORMAL MEETINGS BETWEEN FDA AND ANDA APPLICANTS OF COMPLEX PRODUCTS UNDER GDUFA. OCT 2022. REV. 1.
US FDA. GUIDANCE. FORMAT AND CONTENT FOR THE CMC SECTION OF AN ANNUAL REPORT. SEP 01, 1994.
US FDA. GUIDANCE. FORMAT AND CONTENT OF A REMS DOCUMENT. JAN 2023.
US FDA. GUIDANCE. FORMAT AND CONTENT OF THE CLINICAL AND STATISTICAL SECTIONS OF AN APPLICATION. JUL 01, 1988.
US FDA. GUIDANCE. FORMAT AND CONTENT OF THE HUMAN PHARMACOKINETICS AND BIOAVAILABILITY SECTION OF AN APPLICATION. FEB 01, 1987.
US FDA. GUIDANCE. FORMAT AND CONTENT OF THE MICROBIOLOGY SECTION OF AN APPLICATION. JAN 01, 1990.
US FDA. GUIDANCE. FORMAT AND CONTENT OF THE NONCLINICAL PHARMACOLOGY/TOXICOLOGY SECTION OF AN APPLICATION. FEB 01, 1987.
US FDA. GUIDANCE. FORMAT FOR TRADITIONAL AND ABBREVIATED 10(K)S. SEP 13, 2019.
US FDA. GUIDANCE. FORMATTING, ASSEMBLING AND SUBMITTING NEW DRUG AND ANTIBIOTIC APPLICATIONS. FEB 01, 1987.
US FDA. GUIDANCE. FREQUENTLY ASKED QUESTIONS (FAQS) ON THE STATUS OF REPROCESSED SINGLE USE DEVICES (SUDS) THAT RECEIVE A NOT SUBSTANTIALLY EQUIVALENT (NSE) LETTER. NOV 07, 2004.
US FDA. GUIDANCE. FREQUENTLY ASKED QUESTIONS ABOUT FDA'S REGULATION OF INFANT FORMULA. MAR 01, 2006.
US FDA. GUIDANCE. FREQUENTLY ASKED QUESTIONS ABOUT GRAS FOR SUBSTANCES INTENDED FOR USE IN HUMAN OR ANIMAL FOOD. OCT 2016.
US FDA. GUIDANCE. FREQUENTLY ASKED QUESTIONS ABOUT MEDICAL FOODS; THIRD EDITION. MAR 2023.
US FDA. GUIDANCE. FREQUENTLY-ASKED-QUESTIONS ABOUT THE REPROCESSING AND REUSE OF SINGLE-USE DEVICES BY THIRD-PARTY AND HOSPITAL REPROCESSORS - THREE ADDITIONAL QUESTIONS, FDA STAFF, THIRD-PARTY AND HOSPITAL REPROCESSORS. JUL 16, 2003.
US FDA. GUIDANCE. FREQUENTLY-ASKED-QUESTIONS ABOUT THE REPROCESSING AND REUSE OF SINGLE-USE DEVICES BY THIRD-PARTY AND HOSPITAL REPROCESSORS. JUL 06, 2001.
US FDA. GUIDANCE. FUMONISIN LEVELS IN HUMAN FOODS AND ANIMAL FEEDS. NOV 09, 2001.
US FDA. GUIDANCE. FURTHER AMENDMENTS TO GENERAL REGULATIONS OF THE FOOD AND DRUG ADMINISTRATION TO INCORPORATE TOBACCO PRODUCTS (REVISED)*. SMALL ENTITY COMPLIANCE GUIDE. MAR 2023.
US FDA. GUIDANCE. FURTHER TESTING OF DONATIONS THAT ARE REACTIVE ON A LICENSED DONOR SCREENING TEST FOR ANTIBODIES TO HEPATITIS C VIRUS. OCT 2019.
US FDA. GUIDANCE. GENERAL CLINICAL PHARMACOLOGY CONSIDERATIONS FOR NEONATAL STUDIES FOR DRUGS AND BIOLOGICAL PRODUCTS. JUL 2022.
US FDA. GUIDANCE. GENERAL CONSIDERATIONS FOR ANIMAL STUDIES FOR CARDIOVASCULAR DEVICES. JUL 29, 2010.
US FDA. GUIDANCE. GENERAL CONSIDERATIONS FOR THE CLINICAL EVALUATION OF DRUGS. JAN 01, 1997.
US FDA. GUIDANCE. GENERAL GUIDELINES FOR OTC COMBINATION PRODUCTS. NOV 01, 1978.
US FDA. GUIDANCE. GENERAL PRINCIPLES FOR EVALUATING THE ABUSE DETERRENCE OF GENERIC SOLID ORAL OPIOID DRUG PRODUCTS. NOV 2017.
US FDA. GUIDANCE. GENERAL PRINCIPLES FOR EVALUATING THE HUMAN FOOD SAFETY OF NEW ANIMAL DRUGS USED IN FOOD-PRODUCING ANIMALS. #3. MAY 2022.
US FDA. GUIDANCE. GENERAL PRINCIPLES FOR THE DEVELOPMENT OF VACCINES TO PROTECT AGAINST GLOBAL INFECTIOUS DISEASES. DEC 2011.
US FDA. GUIDANCE. GENERAL PRINCIPLES OF SOFTWARE VALIDATION. JAN 11, 2002.
US FDA. GUIDANCE. GENERAL QUESTIONS AND ANSWERS ON THE BAN OF CIGARETTES THAT CONTAIN CERTAIN CHARACTERIZING FLAVORS (EDITION 2). DEC 23, 2009.
US FDA. GUIDANCE. GENERAL WELLNESS : POLICY FOR LOW RISK DEVICES. SEP 27, 2019.
US FDA. GUIDANCE. GENERAL/SPECIFIC INTENDED USE . NOV 03, 1998.
US FDA. GUIDANCE. GENERIC DRUG USER FEE AMENDMENTS OF 2012 : QUESTIONS AND ANSWERS RELATED TO USER FEE ASSESSMENTS. NOV 2016.
US FDA. GUIDANCE. GIFTS TO FDA : EVALUATION AND ACCEPTANCE. DEC 2016.
US FDA. GUIDANCE. GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE (GUDID). JUN 27, 2014.
US FDA. GUIDANCE. GLUTEN-FREE LABELING OF FOODS. SMALL ENTITY COMPLIANCE GUIDE. JUN 2014.
US FDA. GUIDANCE. GOOD ANDA SUBMISSION PRACTICES. JAN 2022.
US FDA. GUIDANCE. GOOD LABORATORY PRACTICE REGULATIONS MANAGEMENT BRIEFINGS, POST CONFERENCE REPORT, AUG 1979. AUG 31, 1979.
US FDA. GUIDANCE. GOOD LABORATORY PRACTICE REGULATIONS QUESTIONS AND ANSWERS. MAR 02, 1998.
US FDA. GUIDANCE. GOOD MANUFACTURING PRACTICE CONSIDERATIONS FOR RESPONDING TO COVID-19 INFECTION IN EMPLOYEES IN DRUG AND BIOLOGICAL PRODUCTS MANUFACTURING. JUN 2020.
US FDA. GUIDANCE. GOOD MANUFACTURING PRACTICES FOR ANIMAL CELLS, TISSUES, AND CELL- AND TISSUE-BASED PRODUCTS. #253. OCT 2022.
US FDA. GUIDANCE. GOOD PHARMACOVIGILANCE PRACTICES AND PHARMACOEPIDEMIOLOGIC ASSESSMENT:GUIDANCE FOR INDUSTRY. MAR 24, 2005.
US FDA. GUIDANCE. GRANDFATHERING POLICY FOR PACKAGES AND HOMOGENOUS CASES OF PRODUCT WITHOUT A PRODUCT IDENTIFIER. SEP 2018.
US FDA. GUIDANCE. GUIDANCE ('GUIDELINES') FOR EVALUATION OF HYSTEROSCOPIC STERILIZATION DEVICES. MAY 09, 1978.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR DURA SUBSTITUTE DEVICES. NOV 08, 2000.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR NONPRESCRIPTION SUNGLASSES. OCT 08, 1998.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR POWERED MUSCLE STIMULATOR 510(K)S. JUN 08, 1999.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR POWERED SUCTION PUMP 510(K)S. SEP 29, 1998.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR PREMARKET NOTIFICATION SUBMISSIONS FOR NITRIC OXIDE DELIVERY APPARATUS, NITRIC OXIDE ANALYZER AND NITROGEN DIOXIDE ANALYZER AND FOR FDA REVIEWERS. JAN 24, 2000.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR TESTING NON-ARTICULATING, 'MECHANICALLY LOCKED', MODULAR IMPLANT COMPONENTS. APR 30, 1995.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR TESTING ORTHOPEDIC IMPLANTS WITH MODIFIED METALLIC SURFACES APPOSING BONE OR BONE CEMENT. APR 27, 1994.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR THE PREPARATION OF IDES FOR SPINAL SYSTEMS - GUIDANCE FOR INDUSTRY AND/OR FDA STAFF. JAN 12, 2000.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR THE PREPARATION OF PREMARKET NOTIFICATION [510(K)] APPLICATIONS FOR EXERCISE EQUIPMENT. JUL 25, 1995.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR THE PREPARATION OF PREMARKET NOTIFICATION [510(K)] APPLICATIONS FOR HEATING AND COOLING DEVICES. JUL 25, 1995.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR THE PREPARATION OF PREMARKET NOTIFICATION [510(K)] APPLICATIONS FOR MECHANICAL AND POWERED WHEELCHAIRS, AND MOTORIZED THREE-WHEELED VEHICLES. JUL 25, 1995.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR THE PREPARATION OF PREMARKET NOTIFICATION FOR CERAMIC BALL HIP SYSTEMS. JAN 09, 1995.
US FDA. GUIDANCE. GUIDANCE DOCUMENT FOR WASHERS AND WASHER-DISINFECTORS INTENDED FOR PROCESSING REUSABLE MEDICAL DEVICES. JUN 01, 1998.
US FDA. GUIDANCE. GUIDANCE FOR CARDIOVASCULAR INTRAVASCULAR FILTER 510(K) SUBMISSIONS . NOV 25, 1999.
US FDA. GUIDANCE. GUIDANCE FOR DERMABRASION DEVICES. MAR 01, 1999.
US FDA. GUIDANCE. GUIDANCE FOR HOSPITALS, NURSING HOMES, AND OTHER HEALTH CARE FACILITIES - FDA PUBLIC HEALTH ADVISORY: GUIDANCE FOR HOSPITALS, NURSING HOMES, AND OTHER HEALTH CARE FACILITIES. APR 05, 2001.
US FDA. GUIDANCE. GUIDANCE FOR HUMAN SOMATIC CELL THERAPY AND GENE THERAPY. MAR 01, 1998.
US FDA. GUIDANCE. GUIDANCE FOR INDUSTRY FOR THE EVALUATION OF COMBINATION VACCINES FOR PREVENTABLE DISEASES: PRODUCTION, TESTING AND CLINICAL STUDIES.. APR 10, 1997.
US FDA. GUIDANCE. GUIDANCE FOR INDUSTRY FOR THE SUBMISSION OF CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION FOR A THERAPEUTIC RECOMBINANT DNA-DERIVED PRODUCT OR A MONOCLONAL ANTIBODY PRODUCT FOR IN VIVO USE. AUG 01, 1996.
US FDA. GUIDANCE. GUIDANCE FOR INDUSTRY ON THE TESTING OF METALLIC PLASMA SPRAYED COATINGS ON ORTHOPEDIC IMPLANTS TO SUPPORT RECONSIDERATION OF POSTMARKET SURVEILLANCE REQUIREMENTS. FEB 01, 2000.
US FDA. GUIDANCE. GUIDANCE FOR INDUSTRY, Q7A GOOD MANUFACTURING PRACTICE GUIDANCE FOR ACTIVE PHARMACEUTICAL INGREDIENTS. .
US FDA. GUIDANCE. GUIDANCE FOR MANUFACTURERS SEEKING MARKETING CLEARANCE OF EAR, NOSE, AND THROAT ENDOSCOPE SHEATHS USED AS PROTECTIVE BARRIERS. MAR 11, 2000.
US FDA. GUIDANCE. GUIDANCE FOR OVER-THE-COUNTER (OTC) HUMAN CHORIONIC GONADOTROPIN (HCG) 510(K)S - GUIDANCE FOR INDUSTRY AND FDA REVIEWERS/STAFF. JUL 21, 2000.
US FDA. GUIDANCE. GUIDANCE FOR OXYGEN CONSERVING DEVICE 510(K) REVIEW 73 BZD 868.5905 NON-CONTINUOUS VENTILATOR CLASS II. FEB 01, 1989.
US FDA. GUIDANCE. GUIDANCE FOR PREMARKET SUBMISSIONS OF ORTHOKERATOLOGY RIGID GAS PERMEABLE CONTACT LENSES. APR 09, 2000.
US FDA. GUIDANCE. GUIDANCE FOR RECORDS ACCESS AUTHORITY PROVIDED IN TITLE III, SUBTITLE A, OF THE PUBLIC HEALTH SECURITY AND BIOTERRORISM PREPAREDNESS AND RESPONSE ACT OF 2002. DEC 2005.
US FDA. GUIDANCE. GUIDANCE FOR RESORBABLE ADHESION BARRIER DEVICES FOR USE IN ABDOMINAL AND/OR PELVIC SURGERY. JUN 17, 2002.
US FDA. GUIDANCE. GUIDANCE FOR SMALL BUSINESSES: SUBMISSION OF COMMENTS FOR CFSAN RULEMAKING. OCT 20, 2002.
US FDA. GUIDANCE. GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR BIOPSY DEVICES USED IN GASTROENTEROLOGY AND UROLOGY. FEB 09, 1993.
US FDA. GUIDANCE. GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR CONVENTIONAL AND ANTIMICROBIAL FOLEY CATHETERS. SEP 11, 1994.
US FDA. GUIDANCE. GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR ESOPHAGEAL AND TRACHEAL PROSTHESES . APR 27, 1998.
US FDA. GUIDANCE. GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR INTRACORPOREAL LITHOTRIPTERS . NOV 29, 1998.
US FDA. GUIDANCE. GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR PENILE RIGIDITY IMPLANTS. JAN 15, 2000.
US FDA. GUIDANCE. GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR URETERAL STENTS. FEB 09, 1993.
US FDA. GUIDANCE. GUIDANCE FOR THE CONTENT OF PREMARKET NOTIFICATIONS FOR URINE DRAINAGE BAGS. JUN 07, 1994.
US FDA. GUIDANCE. GUIDANCE FOR THE CONTENT OF PREMARKET SUBMISSIONS FOR SOFTWARE CONTAINED IN MEDICAL DEVICES:GUIDANCE FOR INDUSTRY AND FDA STAFF. MAY 11, 2005.
US FDA. GUIDANCE. GUIDANCE FOR THE DEVELOPMENT OF VAGINAL CONTRACEPTIVE DRUGS (NDA). MAR 02, 1998.
US FDA. GUIDANCE. GUIDANCE FOR THE PREPARATION OF A PREMARKET NOTIFICATION APPLICATION FOR A SURGICAL MESH. MAR 01, 1999.
US FDA. GUIDANCE. GUIDANCE FOR THE PREPARATION OF A PREMARKET NOTIFICATION FOR EXTENDED LAPAROSCOPY DEVICES (ELD). AUG 29, 1994.
US FDA. GUIDANCE. GUIDANCE FOR THE SUBMISSION OF 510(K)S FOR SOLID STATE X-RAY IMAGING DEVICES. SEP 1, 2016.
US FDA. GUIDANCE. GUIDANCE FOR THE SUBMISSION OF CABINET X-RAY SYSTEM REPORTS PURSUANT TO 21-CFR 1020.40. FEB 01, 1975.
US FDA. GUIDANCE. GUIDANCE FOR THE SUBMISSION OF PREMARKET NOTIFICATIONS FOR EMISSION COMPUTED TOMOGRAPHY DEVICES AND ACCESSORIES (SPECT AND PET) AND NUCLEAR TOMOGRAPHY SYSTEMS . DEC 02, 1998.
US FDA. GUIDANCE. GUIDANCE FOR THE SUBMISSION OF PREMARKET NOTIFICATIONS FOR PHOTON-EMITTING BRACHYTHERAPY SOURCES. AUG 01, 2000.
US FDA. GUIDANCE. GUIDANCE FOR THE SUBMISSION OF PREMARKET NOTIFICATIONS FOR RADIONUCLIDE DOSE CALIBRATORS . NOV 19, 1998.
US FDA. GUIDANCE. GUIDANCE FOR THE USE OF BAYESIAN STATISTICS IN MEDICAL DEVICE CLINICAL TRIALS. FEB 5, 2010.
US FDA. GUIDANCE. GUIDANCE ON 510(K) SUBMISSIONS FOR KERATOPROSTHESES. MAR 02, 1999.
US FDA. GUIDANCE. GUIDANCE ON INFORMED CONSENT FOR IN VITRO DIAGNOSTIC DEVICE STUDIES USING LEFTOVER HUMAN SPECIMENS THAT ARE NOT INDIVIDUALLY IDENTIFIABLE. APR 25, 2006.
US FDA. GUIDANCE. GUIDANCE ON LABELING OF FOODS THAT NEED REFRIGERATION BY CONSUMERS. FEB 24, 1997.
US FDA. GUIDANCE. GUIDANCE ON MEDICAL DEVICE PATIENT LABELING. APR 19, 2001.
US FDA. GUIDANCE. GUIDANCE ON PMA INTERACTIVE PROCEDURES FOR DAY-100 MEETINGS AND SUBSEQUENT DEFICIENCIES - FOR USE BY CDRH AND INDUSTRY. FEB 18, 1998.
US FDA. GUIDANCE. GUIDANCE ON PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR AUTOMATED ENDOSCOPE WASHERS, WASHER/DISINFECTORS, AND DISINFECTORS INTENDED FOR USE IN HEALTH CARE FACILITIES. AUG 01, 1993.
US FDA. GUIDANCE. GUIDANCE ON PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR SURGICAL GOWNS AND SURGICAL DRAPES. AUG 01, 1993.
US FDA. GUIDANCE. GUIDANCE ON PREMARKET NOTIFICATION 510(K) FOR STERILIZERS INTENDED FOR USE IN HEALTH CARE FACILITIES. MAR 01, 1993.
US FDA. GUIDANCE. GUIDANCE ON SECTION 216 OF THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997. AUG 08, 2000.
US FDA. GUIDANCE. GUIDANCE ON THE CONDUCT AND REVIEW OF STUDIES TO SUPPORT NEW ANIMAL DRUG DEVELOPMENT DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. #270. APR 2020.
US FDA. GUIDANCE. GUIDANCE ON THE CONTENT AND FORMAT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR SHARPS CONTAINERS. OCT 01, 1993.
US FDA. GUIDANCE. GUIDANCE ON THE CONTENT AND ORGANIZATION OF A PREMARKET NOTIFICATION FOR A MEDICAL LASER. MAY 31, 1995.
US FDA. GUIDANCE. GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR CLINICAL ELECTRONIC THERMOMETERS. FEB 28, 1993.
US FDA. GUIDANCE. GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR HYPODERMIC SINGLE LUMEN NEEDLES. MAR 31, 1993.
US FDA. GUIDANCE. GUIDANCE ON THE CONTENT OF PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR PISTON SYRINGES. MAR 31, 1993.
US FDA. GUIDANCE. GUIDANCE ON THE DEPARTMENT OF DEFENSE EXEMPTION FROM THE FDA PERFORMANCE STANDARD FOR LASER PRODUCTS AND FDA. JUL 12, 2002.
US FDA. GUIDANCE. GUIDE FOR DEVELOPING AND USING DATA BASES FOR NUTRITION LABELING. MAR 01, 1998.
US FDA. GUIDANCE. GUIDE FOR ESTABLISHING AND MAINTAINING A CALIBRATION CONSTANCY INTERCOMPARISON SYSTEM FOR MICROWAVE OVEN COMPLIANCE SURVEY INSTRUMENTS (FDA 88-8264)] (PDF ONLY). MAR 01, 1988.
US FDA. GUIDANCE. GUIDE FOR PREPARING PRODUCT REPORTS FOR ULTRASONIC THERAPY PRODUCTS (PHYSICAL THERAPY ONLY). AUG 01, 1996.
US FDA. GUIDANCE. GUIDE FOR THE SUBMISSION OF INITIAL REPORTS ON COMPUTED TOMOGRAPHY X-RAY SYSTEMS. NOV 30, 1985.
US FDA. GUIDANCE. GUIDE TO MINIMIZE MICROBIAL FOOD SAFETY HAZARDS FOR FRESH FRUITS AND VEGETABLES. OCT 25, 1998.
US FDA. GUIDANCE. GUIDE TO MINIMIZE MICROBIAL FOOD SAFETY HAZARDS OF FRESH-CUT FRUITS AND VEGETABLES. FEB 2008.
US FDA. GUIDANCE. GUIDELINE FOR POSTMARKETING REPORTING OF ADVERSE DRUG EXPERIENCES. MAR 01, 1992.
US FDA. GUIDANCE. GUIDELINE FOR SUBMITTING SUPPORTING DOCUMENTATION IN DRUG APPLICATIONS FOR THE MANUFACTURE OF DRUG PRODUCTS. FEB 01, 1987.
US FDA. GUIDANCE. GUIDELINES FOR DETERMINING METRIC EQUIVALENTS OF HOUSEHOLD MEASURES. SEP 30, 1993.
US FDA. GUIDANCE. HANDLING AND RETENTION OF BIOAVAILABILITY BA AND BIOEQUIVALENCE BE TESTING SAMPLES:GUIDANCE FOR INDUSTRY. MAY 25, 2004.
US FDA. GUIDANCE. HEAD LICE INFESTATION : DEVELOPING DRUGS FOR TOPICAL TREATMENT. OCT 2016.
US FDA. GUIDANCE. HEALTH DOCUMENT SUBMISSION REQUIREMENTS FOR TOBACCO PRODUCTS. SEP 2022. REVISED.
US FDA. GUIDANCE. HEMATOLOGIC MALIGNANCIES : REGULATORY CONSIDERATIONS FOR USE OF MINIMAL RESIDUAL DISEASE IN DEVELOPMENT OF DRUG AND BIOLOGICAL PRODUCTS FOR TREATMENT. JAN 2020.
US FDA. GUIDANCE. HEMODIALYSIS BLOOD TUBING SETS - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. APR 23, 2008.
US FDA. GUIDANCE. HEPARIN FOR DRUG AND MEDICAL DEVICE USE : MONITORING CRUDE HEPARIN FOR QUALITY. JUN 2013.
US FDA. GUIDANCE. HEPARIN-CONTAINING MEDICAL DEVICES AND COMBINATIONS PRODUCTS : RECOMMENDATIONS FOR LABELING AND SAFETY TESTING. SEP 20, 2018.
US FDA. GUIDANCE. HIGHLY CONCENTRATED CAFFEINE IN DIETARY SUPPLEMENTS. APR 2018.
US FDA. GUIDANCE. HIGHLY MULTIPLEXED MICROBIOLOGICAL / MEDICAL COUNTERMEASURE IN VITRO NUCLEIC ACID BASED DIAGNOSTIC DEVICES. AUG 27, 2014.
US FDA. GUIDANCE. HOMEOPATHIC DRUG PRODUCTS. DEC 2022.
US FDA. GUIDANCE. HOSPITAL BED SYSTEM DIMENSIONAL AND ASSESSMENT GUIDANCE TO REDUCE ENTRAPMENT. MAR 10, 2006.
US FDA. GUIDANCE. HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA AND VENTILATOR-ASSOCIATED BACTERIAL PNEUMONIA : DEVELOPING DRUGS FOR TREATMENT. JUN 2020.
US FDA. GUIDANCE. HOW TO COMPLETE THE VACCINE ADVERSE EVENT REPORTING SYSTEM FORM (VAERS-1). SEP 09, 1998.
US FDA. GUIDANCE. HOW TO PREPARE A PRE-REQUEST FOR DESIGNATION (PRE-RFD). FEB 2018.
US FDA. GUIDANCE. HOW TO WRITE A RQUEST FOR DESIGNATION (RFD). APR 2011.
US FDA. GUIDANCE. HUMAN GENE THERAPY FOR HEMOPHILIA. JAN 2020.
US FDA. GUIDANCE. HUMAN GENE THERAPY FOR NEURODEGENERATIVE DISEASES. OCT 2022.
US FDA. GUIDANCE. HUMAN GENE THERAPY FOR RARE DISEASES. JAN 2020.
US FDA. GUIDANCE. HUMAN GENE THERAPY FOR RETINAL DISORDERS. JAN 2020.
US FDA. GUIDANCE. HUMAN IMMUNODEFICIENCY VIRUS-1 INFECTION : DEVELOPING ANTIRETROVIRAL DRUGS FOR TREATMENT. NOV 2015. REV. 1.
US FDA. GUIDANCE. HUMAN IMMUNODEFICIENCY VIRUS-1 INFECTION : DEVELOPING SYSTEMIC DRUG PRODUCTS FOR PRE-EXPOSURE PROPHYLAXIS. MAR 2019.
US FDA. GUIDANCE. HUMANITARIAN DEVICE EXEMPTION (HDE) PROGRAM. SEP 6, 2019.
US FDA. GUIDANCE. HUMANITARIAN USE DEVICE (HUD) DESIGNATIONS. SEP 5, 2019.
US FDA. GUIDANCE. HYPERTENSION : DEVELOPING FIXED-COMBINATION DRUG PRODUCTS FOR TREATMENT. NOV 2018.
US FDA. GUIDANCE. HYPERTENSION INDICATION : DRUG LABELING FOR CARDIOVASCULAR OUTCOMES. JAN 30 2020.
US FDA. GUIDANCE. HYPNOTIC DRUGS-CLINICAL EVALUATION. SEP 01, 1977.
US FDA. GUIDANCE. HYSTEROSCOPES AND GYNECOLOGY LAPAROSCOPES - SUBMISSION GUIDANCE FOR A 510(K). MAR 07, 1996.
US FDA. GUIDANCE. HYSTEROSCOPIC AND LAPAROSCOPIC INSUFFLATORS: SUBMISSION GUIDANCE FOR A 510(K). JUL 31, 1995.
US FDA. GUIDANCE. ICH M10 BIOANALYTICAL METHOD VALIDATION AND STUDY SAMPLE ANALYSIS. NOV 2022.
US FDA. GUIDANCE. ICH Q3C MAINTENANCE PROCEDURES FOR THE Q3C IMPURITIES : RESIDUAL SOLVENTS. JUL 2017.
US FDA. GUIDANCE. IDENTIFICATION LABELS FOR CERTAIN CLASS I LASER PRODUCTS (LASER NOTICE 48). SEP 05, 1996.
US FDA. GUIDANCE. IDENTIFICATION OF MANUFACTURING ESTABLISHMENTS IN APPLICATIONS SUBMITTED TO CBER AND CDER. QUESTIONS AND ANSWERS. OCT 2019.
US FDA. GUIDANCE. IMMUNOGENICITY ASSESSMENT FOR THERAPEUTIC PROTEIN PRODUCTS. AUG 2014.
US FDA. GUIDANCE. IMMUNOGENICITY TESTING OF THERAPEUTIC PROTEIN PRODUCTS - DEVELOPING AND VALIDATING ASSAYS FOR ANTI-DRUG ANTIBODY DETECTION. JAN 2019.
US FDA. GUIDANCE. IMMUNOGENICITY-RELATED CONSIDERATIONS FOR LOW MOLECULAR WEIGHT HEPARIN. FEB 2016.
US FDA. GUIDANCE. IMMUNOTOXICITY TESTING GUIDANCE. MAY 05, 1999.
US FDA. GUIDANCE. IMMUNOTOXICOLOGY EVALUATION OF INVESTIGATIONAL NEW DRUGS. NOV 01, 2002.
US FDA. GUIDANCE. IMPACT OF CERTAIN PROVISIONS OF THE REVISED COMMON RULE ON FDA-REGULATED CLINICAL INVESTIGATIONS. OCT 2018.
US FDA. GUIDANCE. IMPACT-RESISTANT LENSES : QUESTIONS AND ANSWERS. SEP 2, 2010.
US FDA. GUIDANCE. IMPLANTABLE PACEMAKER TESTING GUIDANCE. JAN 12, 1990.
US FDA. GUIDANCE. IMPLANTED BLOOD ACCESS DEVICES FOR HEMODIALYSIS. JAN 21, 2016.
US FDA. GUIDANCE. IMPLANTED BRAIN-COMPUTER INTERFACE (BCI) DEVICES FOR PATIENTS WITH PARALYSIS OR AMPUTATION - NON-CLINICAL TESTING AND CLINICAL CONSIDERATIONS. MAY 20, 2021.
US FDA. GUIDANCE. IMPLEMENTATION OF ACCEPTABLE FULL-LENGTH AND ABBREVIATED DONOR HISTORY QUESTIONNAIRES AND ACCOMPANYING MATERIALS FOR USE IN SCREENING DONORS OF SOURCE PLASMA. MAY 2020.
US FDA. GUIDANCE. IMPLEMENTATION OF SECTION 120 OF THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997-ADVISORY COMMITTEES. OCT 01, 1998.
US FDA. GUIDANCE. IMPLEMENTATION OF SECTION 403(T) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (21 U.S.C. 343(T)) REGARDING THE USE OF THE TERM "CATFISH". DEC 06, 2002.
US FDA. GUIDANCE. IMPLEMENTATION OF THE FEE PROVISIONS OF SECTION 107 OF THE FDA FOOD SAFETY MODERNIZATION ACT. OCT 2011.
US FDA. GUIDANCE. IMPLEMENTING A COLLECTION PROGRAM FOR SOURCE PLASMA CONTAINING DISEASE-ASSOCIATED AND OTHER IMMUNOGLOBULIN (IGG) ANTIBODIES. AUG 08, 2006.
US FDA. GUIDANCE. IMPORTATION OF CERTAIN FDA-APPROVED HUMAN PRESCRIPTION DRUGS, INCLUDING BIOLOGICAL PRODUCTS, AND COMBINATION PRODUCTS UNDER SECTION 801(D)(1)(B) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. SEP 2020.
US FDA. GUIDANCE. IMPORTATION OF PRESCRIPTION DRUGS. FINAL RULE. QUESTIONS AND ANSWERS. SMALL ENTITY COMPLIANCE GUIDE. MAY 2022.
US FDA. GUIDANCE. IMPURITIES : RESIDUAL SOLVENTS (MAINTENANCE) PDE FOR TRIETHYLAMINE AND PDE OF METHYLISOBUTYLKETONE. JUL 2017.
US FDA. GUIDANCE. IMPURITIES IN NEW VETERINARY DRUG SUBSTANCES (REVISION). VICH GL10(R). NOV 26, 2007.
US FDA. GUIDANCE. IMPURITIES IN NEW VETERINARY MEDICINAL PRODUCTS (REVISED). VICH GL11 (R). NOV 21, 2007.
US FDA. GUIDANCE. IN VITRO COMPANION DIAGNOSTIC DEVICES. AUG 6, 2014.
US FDA. GUIDANCE. IN VITRO DIAGNOSTIC (IVD) DEVICE STUDIES - FREQUENTLY ASKED QUESTIONS. JUN 25, 2010.
US FDA. GUIDANCE. IN VITRO DRUG INTERACTION STUDIES - CYTOCHROME P450 ENZYME- AND TRANSPORTER-MEDIATED DRUG INTERACTIONS. JAN 2020.
US FDA. GUIDANCE. IN-USE STABILITY STUDIES AND ASSOCIATED LABELING STATEMENTS FOR MULTIPLE-DOSE INJECTABLE ANIMAL DRUG PRODUCTS. #242. NOV 2020.
US FDA. GUIDANCE. INCORPORATION OF PHYSICAL-CHEMICAL IDENTIFIERS INTO SOLID ORAL DOSAGE FORM DRUG PRODUCTS FOR ANTICOUNTERFEITING. OCT 2011.
US FDA. GUIDANCE. IND EXEMPTIONS FOR STUDIES OF LAWFULLY MARKETED DRUG OR BIOLOGICAL PRODUCTS FOR THE TREATMENT OF CANCER. JAN 15, 2004.
US FDA. GUIDANCE. IND MEETINGS FOR HUMAN DRUGS AND BIOLOGICS CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION. MAY 01, 2001.
US FDA. GUIDANCE. INDEPENDENT CONSULTANTS FOR BIOTECHNOLOGY CLINICAL TRIAL PROTOCOLS. AUG 19, 2004.
US FDA. GUIDANCE. INDEXING STRUCTURED PRODUCT LABELING. JUN 2008. REV. 1.
US FDA. GUIDANCE. INDIVIDUAL PATIENT EXPANDED ACCESS APPLICATIONS : FORM FDA 3926. OCT 2017.
US FDA. GUIDANCE. INDS FOR PHASE 2 AND PHASE 3 STUDIES CHEMISTRY, MANUFACTURING, AND CONTROLS INFORMATION. MAY 20, 2003.
US FDA. GUIDANCE. INDUSTRY SUPPORTED SCIENTIFIC AND EDUCATIONAL ACTIVITIES. NOV 01, 1997.
US FDA. GUIDANCE. INDUSTRY-SUPPORTED SCIENTIFIC AND EDUCATIONAL ACTIVITES. DEC 03, 1997.
US FDA. GUIDANCE. INFANT FORMULA ENFORCEMENT DISCRETION POLICY. MAY 2022.
US FDA. GUIDANCE. INFANT FORMULA TRANSITION PLAN FOR EXERCISE OF ENFORCEMENT DISCRETION. SEP 2022.
US FDA. GUIDANCE. INFLUENZA : DEVELOPING DRUGS FOR TREATMENT AND/OR PROPHYLAXIS. APR 2011.
US FDA. GUIDANCE. INFORMATION DISCLOSURE BY MANUFACTURERS TO ASSEMBLERS FOR DIAGNOSTIC X-RAY SYSTEMS . SEP 04, 2003.
US FDA. GUIDANCE. INFORMATION FOR HEALTHCARE ORGANIZATIONS ABOUT FDA'S "CYBERSECURITY FOR NETWORKED MEDICAL DEVICES CONTAINING OFF-THE-SHELF (OTS) SOFTWARE". FEB 08, 2005.
US FDA. GUIDANCE. INFORMATION FOR KERATOME MANUFACTURERS REGARDING LASIK. JUN 20, 2001.
US FDA. GUIDANCE. INFORMATION REQUEST AND DISCIPLINE REVIEW LETTERS UNDER THE PRESCRIPTION DRUG USER FEE ACT. NOV 21, 2001.
US FDA. GUIDANCE. INFORMATION REQUESTS AND DISCIPLINE REVIEW LETTERS UNDER GDUFA. OCT 2022. REV 1.
US FDA. GUIDANCE. INFORMATION SHEET. FDA INSPECTIONS OF CLINICAL INVESTIGATORS. JUN 2010.
US FDA. GUIDANCE. INFORMATION SHEET. FREQUENTLY ASKED QUESTIONS - STATEMENT OF INVESTIGATOR (FORM 1572). MAY 2010.
US FDA. GUIDANCE. INFORMATION TO SUPPORT A CLAIM OF ELECTORMAGNETIC COMPATIBILITY (EMC) OF ELECTRICALLY-POWERED MEDICAL DEVICES. JUL 11, 2016.
US FDA. GUIDANCE. INFORMED CONSENT RECOMMENDATIONS FOR SOURCE PLASMA DONORS PARTICIPATING IN PLASMAPHERESIS AND IMMUNIZATION PROGRAMS. MAR 24, 2022.
US FDA. GUIDANCE. INFUSION PUMPS TOTAL PRODUCT LIFE CYCLE. DEC 2, 2014.
US FDA. GUIDANCE. INGREDIENTS DECLARED AS EVAPORATED CANE JUICE. MAY 2016.
US FDA. GUIDANCE. INITIATION OF VOLUNTARY RECALLS UNDER 21 CFR PART 7, SUBPART C. MAR 2022.
US FDA. GUIDANCE. INORGANIC ARSENIC IN RICE CEREALS FOR INFANTS : ACTION LEVEL. AUG 2020.
US FDA. GUIDANCE. INSANITARY CONDITIONS AT COMPOUNDING FACILITIES. NOV 2020.
US FDA. GUIDANCE. INSPECTION AND FIELD TESTING OF RADIATION-EMITTING ELECTRONIC PRODUCTS : ATTACHMENT A. OCT 2007.
US FDA. GUIDANCE. INSPECTION AND FIELD TESTING OF RADIATION-EMITTING ELECTRONIC PRODUCTS : ATTACHMENT C : SPECIFIC INSTRUCTIONS FOR SUNLAMP PRODUCT INSPECTIONS AND TESTS. OCT 2007.
US FDA. GUIDANCE. INSTITUTIONAL REVIEW BOARD (IRB) REVIEW OF INDIVIDUAL PATIENT EXPANDED ACCESS REQUESTS FOR INVESTIGATIONAL DRUGS AND BIOLOGICAL PRODUCTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. JUN 2020.
US FDA. GUIDANCE. INSTITUTIONAL REVIEW BOARD (IRB). WRITTEN PROCEDURES. MAY 2018.
US FDA. GUIDANCE. INSTITUTIONAL REVIEW BOARDS FREQUENTLY ASKED QUESTIONS. JAN 01, 1998.
US FDA. GUIDANCE. INSTRUCTIONS FOR USE - PATIENT LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS AND DRUG-DEVICE AND BIOLOGIC-DEVICE COMBINATION PRODUCTS - OCNTENT AND FORMAT. JUL 2022.
US FDA. GUIDANCE. INTEGRATED SUMMARIES OF EFFECTIVENESS AND SAETY : LOCATION WITHIN THE COMMON TECHNICAL DOCUMENT. APR 2009.
US FDA. GUIDANCE. INTEGRATED SUMMARY OF EFFECTIVENESS. OCT 2015.
US FDA. GUIDANCE. INTEGRATION OF DOSE-COUNTING MECHANISMS INTO MDI DRUG PRODUCTS. MAR 13, 2003.
US FDA. GUIDANCE. INTENT TO EXEMPT CERTAIN UNCLASSIFIED MEDICAL DEVICES FROM PREMARKET NOTIFICATION REQUIREMENTS. FEB 8, 2019.
US FDA. GUIDANCE. INTERACTING WITH THE FDA ON COMPLEX INNOVATIVE TRIAL DESIGNS FOR DRUGS AND BIOLOGICAL PRODUCTS. DEC 2020.
US FDA. GUIDANCE. INTERIM POLICY ON COMPOUNDING USING BULK DRUG SUBSTANCES UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. JAN 2017. REV. 1.
US FDA. GUIDANCE. INTERIM POLICY ON COMPOUNDING USING BULK DRUG SUBSTANCES UNDER SECTION 503B OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT. JAN 2017. REV. 1.
US FDA. GUIDANCE. INTERIM PROCEDURES FOR QUALIFIED HEALTH CLAIMS IN THE LABELING OF CONVENTIONAL HUMAN FOOD AND HUMAN DIETARY SUPPLEMENTS. JUL 11, 2003.
US FDA. GUIDANCE. INTERNAL RADIOACTIVE CONTAMINATION —DEVELOPMENT OF DECORPORATION AGENTS. MAR 02, 2006.
US FDA. GUIDANCE. INTERPRETATION OF AND COMPLIANCE POLICY FOR CERTAIN LABEL REQUIREMENT; APPLICABILITY OF CERTAIN FEDERAL FOOD, DRUG, AND COSMETIC ACT REQUIREMENTS TO VAPE SHOPS (REVISED)*. MAR 2023.
US FDA. GUIDANCE. INTERPRETATION OF THE “DEEMED TO BE A LICENSE” PROVISION OF THE BIOLOGICS PRICE COMPETITION AND INNOVATION ACT OF 2009. DEC 2018.
US FDA. GUIDANCE. INTERPRETING SAMENESS OF GENE THERAPY PRODUCTS UNDER THE ORPHAN DRUG REGULATIONS. SEP 2021.
US FDA. GUIDANCE. INTERPRETING SAMENESS OF MONOCLONAL ANTIBODY PRODUCTS UNDER THE ORPHAN DRUG REGULATIONS. APR 2014.
US FDA. GUIDANCE. INTERSTATE SHIPMENT OF EXPERIMENTAL PACKS OF FOOD VARYING FROM THE REQUIREMENTS OF DEFINITIONS AND STANDARDS OF IDENTITY. NOV 2021.
US FDA. GUIDANCE. INTRAVASCULAR ADMINISTRATION SETS. PREMARKET NOTIFICATION SUBMISSIONS (510(K)). JUL 11, 2008.
US FDA. GUIDANCE. INTRAVASCULAR CATHETERS, WIRES, AND DELIVERY SYSTEMS WITH LUBRICIOUS COATINGS - LABELING CONSIDERATIONS. OCT 10, 2019.
US FDA. GUIDANCE. INVESTIGATING AND REPORTING ADVERSE REACTIONS RELATED TO HUMAN CELLS, TISSUES, AND CELLULALR AND TISSUE-BASED PRODUCTS (HCT/PS) REGULATED SOLELY UNDER SECTION 361 OF THE PUBLIC HEALTH SERVICE ACT AND 21 CFR PART 1271. MAR 2016.
US FDA. GUIDANCE. INVESTIGATING OUT-OF-SPECIFICATION TEST RESULTS FOR PHARMACEUTICAL PRODUCTION. MAY 2022. REVISION 1.
US FDA. GUIDANCE. INVESTIGATIONAL COVID-19 CONVALESCENT PLASMA. JAN 7, 2022.
US FDA. GUIDANCE. INVESTIGATIONAL DEVICE EXEMPTION (IDE) GUIDANCES FOR RETINAL PROSTHESES. MAR 6, 2013.
US FDA. GUIDANCE. INVESTIGATIONAL DEVICE EXEMPTIONS (IDES) FOR DEVICES INDICATED FOR NOCTURNAL HOME HEMODIALYSIS. APR 15, 2008.
US FDA. GUIDANCE. INVESTIGATIONAL DEVICE EXEMPTIONS (IDES) FOR EARLY FEASIBILITY MEDIAL DEVICE CLINICAL STUDIES, INCLUDING CERTAIN FIRST IN HUMAN (FIH) STUDIES. OCT 1, 2013.
US FDA. GUIDANCE. INVESTIGATIONAL ENZYME REPLACEMENT THERAPY PRODUCTS : NONCLINICAL ASSESSMENT. OCT 2019.
US FDA. GUIDANCE. INVESTIGATIONAL IN VITRO DIAGNOSTICS IN ONCOLOGY TRIALS : STREAMLINED SUBMISSION PROCESS FOR STUDY RISK DETERMINATION. OCT 2019.
US FDA. GUIDANCE. INVESTIGATIONAL MEDICAL LASER SIGNIFICANT RISK DEVICE (LASER NOTICE 31). MAY 18, 1981.
US FDA. GUIDANCE. INVESTIGATIONAL NEW DRUG APPLICATIONS (INDS) - DETERMINING WHETHER HUMAN RESEARCH STUDIES CAN BE CONDUCTED WITHOUT AN IND. SEP 2013.
US FDA. GUIDANCE. INVESTIGATIONAL NEW DRUG APPLICATIONS FOR MINIMALLY MANIPULATED, UNRELATED ALLOGENEIC PLACENTAL / UMBILICAL CORD BLOOD INTENDED FOR HEMATOPOIETIC AND IMMUNOLOGIC RECONSTITUTION IN PATIENTS WITH DISORDERS AFFECTING THE HEMATOPOIETIC SYSTEM. MAR 2014.
US FDA. GUIDANCE. INVESTIGATIONAL NEW DRUG APPLICATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS. DEC 2012.
US FDA. GUIDANCE. INVESTIGATIONAL USE OF DEEMED, FINISHED TOBACCO PRODUCTS THAT WERE ON THE U.S. MARKET ON AUGUST 8, 2016, DURING THE DEEMING COMPLIANCE PERIODS. OCT 2016.
US FDA. GUIDANCE. INVESTIGATOR RESPONSIBLITIES - PROTECTING THE RIGHTS, SAFETY, AND WELFARE OF STUDY SUBJECTS. OCT 2009.
US FDA. GUIDANCE. IRB CONTINUING REVIEW AFTER CLINICAL INVESTIGATION APPROVAL. FEB 2012.
US FDA. GUIDANCE. IRB RESPONSIBILITIES FOR REVIEWING THE QUALIFICATIONS OF INVESTIGATORS, ADEQUACY OF RESEARCH SITES, AND THE DETERMINATION OF WHETHER AN IND/IDE IS NEEDED. AUG 2013.
US FDA. GUIDANCE. IRB REVIEW OF STAND-ALONE HIPAA AUTHORIZATIONS UNDER FDA REGULATIONS. AUG 16, 2003.
US FDA. GUIDANCE. IRB WAIVER OR ALTERATION OF INFORMED CONSENT FOR CLINICAL INVESTIGATIONS INVOLVING NO MORE THAN MINIMAL RISK TO HUMAN SUBJECTS. JUL 2017.
US FDA. GUIDANCE. IRRITABLE BOWEL SYDNROME - CLINICAL EVALUATION OF DRUGS FOR TREATMENT. MAY 2012.
US FDA. GUIDANCE. JUICE HACCP AND THE FDA FOOD SAFETY MODERNIZATION ACT. DEC 2021.
US FDA. GUIDANCE. JUICE HAZARD ANALYSIS CRITICAL CONTROL POINT HAZARDS AND CONTROLS GUIDANCE, FIRST EDITION. MAR 03, 2004.
US FDA. GUIDANCE. KERATOME AND REPLACEMENT KERATOME BLADES PREMARKET NOTIFICATION [510(K)] SUBMISSIONS. SEP 18, 2006.
US FDA. GUIDANCE. KIT CERTIFICATION FOR 510(K)S. JUN 30, 1997.
US FDA. GUIDANCE. LABEL COMPREHENSION STUDIES FOR NONPRESCRIPTION DRUG PRODUCTS. AUG 2010.
US FDA. GUIDANCE. LABELING - REGULATORY REQUIREMENTS FOR MEDICAL DEVICES (FDA 89-4203). SEP 01, 1989.
US FDA. GUIDANCE. LABELING AND EFFECTIVENESS TESTING : SUNSCREEN DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE. SMALL ENTITY COMPLIANCE GUIDE. DEC 2012.
US FDA. GUIDANCE. LABELING FOR BIOSIMILAR PRODUCTS. JUL 2018.
US FDA. GUIDANCE. LABELING FOR BRONCHODILATORS : COLD, COUGH, ALLERGY, BRONCHODILATOR, AND ANTIASTHMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE. NOV 2012.
US FDA. GUIDANCE. LABELING FOR COMBINED HORMONAL CONTRACEPTIVES. DEC 2017.
US FDA. GUIDANCE. LABELING FOR COSMETICS CONTAINING ALPHA HYDROXY ACIDS. JAN 10, 2005.
US FDA. GUIDANCE. LABELING FOR ELECTRONIC ANTI-THEFT SYSTEMS. AUG 15, 2000.
US FDA. GUIDANCE. LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - DETERMINING ESTABLISHED PHARMACOLOGIC CLASS FOR USE IN THE HIGHLIGHTS OF PRESCRIBING INFORMATION. OCT 2009.
US FDA. GUIDANCE. LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - IMPLEMENTING THE PLR CONTENT AND FORMAT REQUIREMENTS. FEB 2013.
US FDA. GUIDANCE. LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS APPROVED UNDER THE ACCELERATED APPROVAL REGULATORY PATHWAY. JAN 2019.
US FDA. GUIDANCE. LABELING FOR PERMANENT HYSTEROSCOPICALLY-PLACED TUBAL IMPLANTS INTENDED FOR STERILIZATION. OCT 31, 2016.
US FDA. GUIDANCE. LABELING OF CERTAIN BEERS SUBJECT TO THE LABELING JURISDICTION OF THE FOOD AND DRUG ADMINISTRATION. DEC 2014.
US FDA. GUIDANCE. LABELING OF INFANT FORMULA. MAR 2023.
US FDA. GUIDANCE. LABELING OF NONPRESCRIPTION HUMAN DRUG PRODUCTS MARKETED WITHOUT AN APPROVED APPLICATION AS REQUIRED BY THE DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT : QUESTIONS AND ANSWERS. SEP 2009.
US FDA. GUIDANCE. LABELING OF RED BLOOD CELL UNITS WITH HISTORICAL ANTIGEN TYPING RESULTS. DEC 2018.
US FDA. GUIDANCE. LABELING OTC HUMAN DRUG PRODUCTS - QUESTIONS AND ANSWERS. DEC 2008.
US FDA. GUIDANCE. LABELING OTC HUMAN DRUG PRODUCTS UPDATING LABELING IN RLDS AND ANDAS. OCT 18, 2002.
US FDA. GUIDANCE. LABELING OTC HUMAN DRUG PRODUCTS USING A COLUMN FORMAT. DEC 19, 2000.
US FDA. GUIDANCE. LABELING OTC HUMAN DRUG PRODUCTS. SMALL ENTITY COMPLIANCE GUIDE. MAY 2009.
US FDA. GUIDANCE. LABELING RECOMMENDATIONS FOR SINGLE-USE DEVICES REPROCESSED BY THIRD PARTIES AND HOSPITALS: FINAL GUIDANCE FOR INDUSTRY AND FDA. JUL 30, 2001.
US FDA. GUIDANCE. LASER ENERGY SOURCE (LASER NOTICE 2). NOV 21, 1975.
US FDA. GUIDANCE. LASER LIGHT SHOWS SUBJECT TO LASER PRODUCT PERFORMANCE STANDARD (LASER NOTICE 22). NOV 23, 1977.
US FDA. GUIDANCE. LASER PRODUCTS - CONFORMANCE WITH IEC 60825-1 AND IEC 60601-2-22. LASER NOTICE NO. 5. JUN 24, 2007.
US FDA. GUIDANCE. LASER PRODUCTS - CONFORMANCE WITH IEC 60825-1 ED. 3 AND IEC 60601-2-22 ED. 3.1 (LASER NOTICE NO. 56). FEB 21, 2023.
US FDA. GUIDANCE. LASERS MANUFACTURED AND USED IN-HOUSE (LASER NOTICE 14). NOV 23, 1976.
US FDA. GUIDANCE. LATEX CONDOMS FOR MEN - INFORMATION FOR 510(K) PREMARKET NOTIFICATIONS: USE OF CONSENSUS STANDARDS FOR ABBREVIATED SUBMISSIONS. JUL 23, 1998.
US FDA. GUIDANCE. LEAD IN CANDY LIKELY TO BE CONSUMED FREQUENTLY BY SMALL CHILDREN. NOV 2006.
US FDA. GUIDANCE. LETTER - MANUFACTURERS, DISTRIBUTORS AND IMPORTERS OF CONDOM PRODUCTS (INCLUDED IN CONDOM PACKET 398) : LETTER - MANUFACTURERS, DISTRIBUTORS AND IMPORTERS OF CONDOM PRODUCTS. FEB 23, 1994.
US FDA. GUIDANCE. LETTER REGARDING POINT OF PURCHASE FOOD LABELING. OCT 2009.
US FDA. GUIDANCE. LETTER TO FIRMS THAT GROW, HARVEST, SORT, PACK, OR SHIP FRESH CILANTRO. MAR 2011.
US FDA. GUIDANCE. LETTER TO FIRMS THAT GROW, HARVEST, SORT, PACK, PROCESS, OR SHIP FRESH CANTALOUPE. NOV 2011.
US FDA. GUIDANCE. LETTER TO INDUSTRY, POWERED WHEELCHAIR MANUFACTURERS FROM RMJOHNSON. MAY 10, 1993.
US FDA. GUIDANCE. LETTER TO INDUSTRY, STATE AND LOCAL FOOD REGULATORS AND INSPECTORS REGARDING WEB-BASED ALERT TRAINING. FEB 2007.
US FDA. GUIDANCE. LETTER TO MANUFACTURERS, IMPORTERS, AND DISTRIBUTORS OF IMPORTED CANDY AND CANDY WRAPPERS. JUN 13, 1995.
US FDA. GUIDANCE. LETTER TO STATE REGULATORY AGENCIES AND FIRMS THAT PRODUCE TREATED (BUT NOT PASTEURIZED) AND UNTREATED JUICE AND CIDER. SEP 22, 2005.
US FDA. GUIDANCE. LEVERAGING EXISTING CLINICAL DATA FOR EXTRAPOLATION TO PEDIATRIC USES OF MEDICAL DEVICES. JUN 21, 2016.
US FDA. GUIDANCE. LEVOTHYROXINE SODIUM PRODUCTS ENFORCEMENT OF AUGUST 14, 2001 COMPLIANCE DATE AND SUBMISSION OF NEW APPLICATIONS. JUL 13, 2001.
US FDA. GUIDANCE. LEVOTHYROXINE SODIUM TABLETS - IN VIVO PHARMACOKINETIC AND BIOAVAILABILITY STUDIES AND IN VITRO DISSOLUTION TESTING. MAR 08, 2001.
US FDA. GUIDANCE. LIMITED POPULATION PATHWAY FOR ANTIBACTERIAL AND ANTIFUNGAL DRUGS. AUG 2020.
US FDA. GUIDANCE. LIMITING THE USE OF CERTAIN PHTHALATES AS EXCIPIENTS IN CDER-REGULATED PRODUCTS. DEC 2012.
US FDA. GUIDANCE. LIPOSOME DRUG PRODUCTS. CHEMISTRY, MANUFACTURING, AND CONTROLS, HUMAN PHARMACOKINETICS AND BIOAVAILABILITY, AND LABELING DOCUMENTATION. APR 2018.
US FDA. GUIDANCE. LISTING OF INGREDIENTS IN TOBACCO PRODUCTS (REVISED)*. MAR 2023.
US FDA. GUIDANCE. LIVE CASE PRESENTATIONS DURING INVESTIGATIONAL DEVICE EXEMPTION (IDE) CLINICAL TRIALS. JUL 11, 2019.
US FDA. GUIDANCE. LOCAL ANESTHETICS-CLINICAL EVALUATION. MAR 02, 1998.
US FDA. GUIDANCE. LOGICAL OBSERVATION IDENTIFIERS NAMES AND CODES FOR IN VITRO DIAGNOSTIC TESTS. JUN 15, 2018.
US FDA. GUIDANCE. LONG TERM FOLLOW-UP AFTER ADMINISTRATION OF HUMAN GENE THERAPY PRODUCTS. JAN 2020.
US FDA. GUIDANCE. LOW POWER LASER REPORTING EXEMPTION (LASER NOTICE 41). AUG 09, 1988.
US FDA. GUIDANCE. LOW-ACID FOODS PACKAGED IN HERMETICALLY SEALED CONTAINERS (LACF) REGULATION AND THE FDA FOOD SAFETY MODERNIZATION ACT. DEC 2021.
US FDA. GUIDANCE. M2 ECTD: ELECTRONIC COMMON TECHNICAL DOCUMENT SPECIFICATION. APR 01, 2003.
US FDA. GUIDANCE. M2: ECTD SPECIFICATION QUESTIONS AND ANSWERS AND CHANGE REQUESTS. MAR 14, 2005.
US FDA. GUIDANCE. M3(R2) NONCLINICAL SAFETY STUDIES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS AND MARKETING AUTHORIZATION FOR PHARMACEUTICALS. JAN 2010. REV. 1.
US FDA. GUIDANCE. M3(R2) NONCLINICAL SAFETY STUIDES FOR THE CONDUCT OF HUMAN CLINICAL TRIALS AND MARKETING AUTORIZATION FOR PHARMACEUTICALS. QUESTIONS AND ANSWERS (R2). FEB 2013. REV. 1.
US FDA. GUIDANCE. M4 ORGANIZATION OF THE COMMON TECHNICAL DOCUMENT FOR THE REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE. OCT 2017.
US FDA. GUIDANCE. M4: THE CTD EFFICACY QUESTIONS AND ANSWERS. DEC 01, 2004.
US FDA. GUIDANCE. M4: THE CTD GENERAL QUESTIONS AND ANSWERS. DEC 22, 2004.
US FDA. GUIDANCE. M4: THE CTD QUALITY QUESTIONS AND ANSWERS /LOCATION ISSUES. JUN 09, 2004.
US FDA. GUIDANCE. M4: THE CTD QUALITY. AUG 01, 2001.
US FDA. GUIDANCE. M4: THE CTD SAFETY QUESTIONS AND ANSWERS. FEB 04, 2003.
US FDA. GUIDANCE. M4E(R2) : THE CTD - EFFICACY. JUL 2017.
US FDA. GUIDANCE. M4S: THE CTD SAFETY APPENDICES. AUG 01, 2001.
US FDA. GUIDANCE. M4S: THE CTD SAFETY. AUG 01, 2001.
US FDA. GUIDANCE. M7 ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK - QUESTIONS AND ANSWERS. JUN 29, 2020.
US FDA. GUIDANCE. M7(R1) ADDENDUM TO ICH M7 : ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK. SEP 2015.
US FDA. GUIDANCE. M7(R1) ASSESSMENT AND CONTROL OF DNA REACTIVE (MUTAGENIC) IMPURITIES IN PHARMACEUTICALS TO LIMIT POTENTIAL CARCINOGENIC RISK. MAR 2018.
US FDA. GUIDANCE. M7(R2) ADDENDUM: APPLICATION OF THE PRINCIPLES OF THE ICH M7 GUIDELINE TO CALCULATION OF COMPOUND-SPECIFIC ACCEPTABLE INTAKES. APR 2022.
US FDA. GUIDANCE. M8 ELECTRONIC COMMON TECHNICAL DOCUMENT (ECTD) V4.0 DRAFT IMPLEMENTATION GUIDE V2.0 AND ECTD IMPLEMENTATION PACKAGE DRAFT SPECIFICATIONS FOR SUBMISSION FORMATS V2.0. APR 2015.
US FDA. GUIDANCE. M9 BIOPHARMACEUTICS CLASSIFICATION SYSTEM-BASED BIOWAIVERS. MAY 2021.
US FDA. GUIDANCE. MAGNETIC RESONANCE (MR) RECEIVE-ONLY COIL-PERFORMANCE CRITERIA FOR SAFETY AND PERFORMANCE BASED PATHWAY. DEC 11, 2020.
US FDA. GUIDANCE. MAINTENANCE PROCEDURE Q3C. JUL 2017.
US FDA. GUIDANCE. MALE BREAST CANCER : DEVELOPING DRUGS FOR TREATMENT. AUG 2020.
US FDA. GUIDANCE. MAMMOGRAPHY FACILITY SURVEYS, MAMMOGRAPHY EQUIPMENT EVALUATIONS, AND MEDICAL PHYSICIST QUALIFICATION REQUIREMENTS UNDER MQSA. SEP 12, 2005.
US FDA. GUIDANCE. MANUFACTURE AND CERTIFICATION OF LASER KITS (LASER NOTICE 13). OCT 14, 1976.
US FDA. GUIDANCE. MANUFACTURE OF BLOOD COMPONENTS USING A PATHOGEN REDUCTION DEVICE IN BLOOD ESTABLISHMENTS : QUESTIONS AND ANSWERS. NOV 2021.
US FDA. GUIDANCE. MANUFACTURERS AND INITIAL DISTRIBUTORS OF SHARPS CONTAINERS AND DESTROYERS USED BY HEALTH CARE PROFESSIONALS. FEB 03, 1994.
US FDA. GUIDANCE. MANUFACTURERS SHARING PATIENT-SPECIFIC INFORMATION FROM MEDICAL DEVICES WITH PATIENTS UPON REQUEST. OCT 30, 2017.
US FDA. GUIDANCE. MANUFACTURERS/ASSEMBLERS OF DIAGNOSTIC X-RAY SYSTEMS: ENFORCEMENT POLICY FOR POSITIVE-BEAM LIMITATION (PBL) REQUIREMENTS IN 21 CFR 1020.31(G) :. OCT 13, 1993.
US FDA. GUIDANCE. MANUFACTURING BIOLOGICAL INTERMEDIATES AND BIOLOGICAL DRUG SUBSTANCES USING SPORE-FORMING MICROORGANISMS. SEP 2007.
US FDA. GUIDANCE. MANUFACTURING CONSIDERATIONS FOR LICENSED AND INVESTIGATIONAL CELLULAR AND GENE THERAPY PRODUCTS DURING COVID-19 PUBLIC HEALTH EMERGENCY. JAN 2021.
US FDA. GUIDANCE. MANUFACTURING SITE CHANGE SUPPLEMENTS : CONTENT AND SUBMISSION. DEC 17, 2018.
US FDA. GUIDANCE. MANUFACTURING, SUPPLY CHAIN, AND DRUG AND BIOLOGICAL PRODUCT INSPECTIONS DURING COVID-19 PUBLIC HEALTH EMERGENCY. QUESTIONS AND ANSWERS. MAY 17, 2021.
US FDA. GUIDANCE. MARKETED UNAPPROVED DRUGS - COMPLIANCE POLICY GUIDE. SEC 440.100 MARKETED NEW DRUGS WITHOUT APPROVED NDAS OR ANDAS. SEP 19, 2011.
US FDA. GUIDANCE. MARKETING CLEARANCE OF DIAGNOSTIC ULTRASOUND SYSTEMS AND TRANSDUCERS. FEB 21, 2023.
US FDA. GUIDANCE. MARKETING STATUS NOTIFICATIONS UNDER SECTION 506I OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT; CONTENT AND FORMAT. AUG 2020.
US FDA. GUIDANCE. MASTER FILES PART III - GUIDANCE ON SCIENTIFIC AND TECHNICAL INFORMATION. JUN 01, 1987.
US FDA. GUIDANCE. MASTER PROTOCOLS : EFFICIENT CLINICAL TRIAL DESIGN STRATEGIES TO EXPEDITE DEVELOPMENT OF ONCOLOGY DRUGS AND BIOLOGICS. MAR 2022.
US FDA. GUIDANCE. MAXIMAL USAGE TRIALS FOR TOPICALLY APPLIED ACTIVE INGREDIENTS BEING CONSIDERED FOR INCLUSION IN AN OVER-THE-COUNTER MONOGRAPHY : STUDY ELEMENTS AND CONSIDERATIONS. MAY 2019.
US FDA. GUIDANCE. MEASURES TO ADDRESS THE RISK FOR CONTAMINATION BY SALMONELLA SPECIES IN FOOD CONTAINING A PEANUT-DERIVED PRODUCT AS AN INGREDIENT. MAR 2009.
US FDA. GUIDANCE. MEASURES TO ADDRESS THE RISK FOR CONTAMINATION BY SALMONELLA SPECIES IN FOOD CONTAINING A PISTACHIO-DERIVED PRODUCT AS AN INGREDIENT. SEP 2011.
US FDA. GUIDANCE. MEDIA FILLS FOR VALIDATION OF ASEPTIC PREPARATIONS FOR POSITRON EMISSION TOMOGRAPHY (PET) DRUGS. APR 2012.
US FDA. GUIDANCE. MEDICAL DEVICE ACCESSORIES - DESCRIBING ACCESSORIES AND CLASSIFICATION PATHWAYS. DEC 20, 2017.
US FDA. GUIDANCE. MEDICAL DEVICE CLASSIFICATION PRODUCT CODES. APR 11, 2013.
US FDA. GUIDANCE. MEDICAL DEVICE DATA SYSTEMS, MEDICAL IMAGE STORAGE DEVICES, AND MEDICAL IMAGE COMMUNICATIONS DEVICES. SEP 28, 2022.
US FDA. GUIDANCE. MEDICAL DEVICE REPORTING FOR MANUFACTURERS. NOV 8, 2016.
US FDA. GUIDANCE. MEDICAL DEVICE REPORTING FOR USER FACILITIES. APR 01, 1996.
US FDA. GUIDANCE. MEDICAL DEVICE TRACKING. MAR 27, 2014.
US FDA. GUIDANCE. MEDICAL DEVICE USER FEE AND MODERNIZATION ACT OF 2002, VALIDATION DATA IN PREMARKET NOTIFICATION SUBMISSIONS (510(K)S) FOR REPROCESSED SINGLE-USE MEDICAL DEVICES. JUN 02, 2004.
US FDA. GUIDANCE. MEDICAL DEVICE USER FEE. SMALL BUSINESS QUALIFICATION AND CERTIFICATION. AUG 1, 2018.
US FDA. GUIDANCE. MEDICAL DEVICES AND CLINICAL TRIAL DESIGN FOR THE TREATMENT OR IMPROVEMENT IN THE APPEARANCE OF FUNGALLY-INFECTED NAILS. MAR 7, 2016.
US FDA. GUIDANCE. MEDICAL DEVICES CONTAINING MATERIALS DERIVED FROM ANIMAL SOURCES (EXCEPT FOR IN VITRO DIAGNOSTIC DEVICES). MAR 15, 2019.
US FDA. GUIDANCE. MEDICAL DEVICES WITH SHARPS INJURY PREVENTION FEATURES -GUIDANCE FOR INDUSTRY AND FDA STAFF. AUG 08, 2005.
US FDA. GUIDANCE. MEDICAL GLOVE GUIDANCE MANUAL. JAN 22, 2008.
US FDA. GUIDANCE. MEDICAL LASER DELIVERY SYSTEM INTERLOCKS (LASER NOTICE 34). JAN 20, 1985.
US FDA. GUIDANCE. MEDICAL PRODUCT COMMUNICATIONS THAT ARE CONSISTENT WITH THE FDA-REQUIRED LABELING. QUESTIONS AND ANSWERS. JUN 2018.
US FDA. GUIDANCE. MEDICAL X-RAY IMAGING DEVICES CONFORMANCE WITH IEC STANDARDS. FEB 21, 2023.
US FDA. GUIDANCE. MEDICATION GUIDES - ADDING A TOLL-FREE NUMBER FOR REPORTING ADVERSE EVENTS. JUN 2009.
US FDA. GUIDANCE. MEDICATION GUIDES - DISTRIBUTION REQUIREMENTS AND INCLUSION IN RISK EVALUATION AND MITIGATION STRATEGIES (REMS). NOV 2011.
US FDA. GUIDANCE. MEETINGS WITH INDUSTRY AND INVESTIGATORS ON THE RESEARCH AND DEVELOPMENT OF TOBACCO PRODUCTS. JUN 2020.
US FDA. GUIDANCE. MEETINGS WITH THE OFFICE OF ORPHAN PRODUCTS DEVELOPMENT. JUL 9, 2015.
US FDA. GUIDANCE. MENSTRUAL TAMPONS AND PADS: INFORMATION FOR PREMARKET NOTIFICATION SUBMISSIONS (510(K)S) - GUIDANCE FOR INDUSTRY AND FDA STAFF. JUL 26, 2005.
US FDA. GUIDANCE. MENU LABELING : SUPPLEMENTAL. MAY 2018.
US FDA. GUIDANCE. METAL EXPANDABLE BILIARY STENTS - PREMARKET NOTIFICATION (510(K)) SUBMISSIONS. JUL 27, 2019.
US FDA. GUIDANCE. METAPROTERENOL SULFATE AND ALBUTEROL METERED DOSE INHALERS IN VITRO. JUN 27, 1989.
US FDA. GUIDANCE. MICROBIOLOGICAL CONSIDERATIONS FOR ANTIMICROBIAL AGENTS USED IN FOOD APPLICATIONS. SEP 2021.
US FDA. GUIDANCE. MICROBIOLOGY DATA FOR SYSTEMIC ANTIBACTERIAL DRUGS - DEVELOPMENT, ANALYSIS, AND PRESENTATION. FEB 2018. REV. 2.
US FDA. GUIDANCE. MICRODOSE RADIOPHARMACEUTICAL DIAGNOSTIC DRUGS : NONCLINICAL STUDY RECOMMENDATIONS. AUG 2018.
US FDA. GUIDANCE. MIGRAINE : DEVELOPING DRUGS FOR ACUTE TREATMENT. FEB 2018.
US FDA. GUIDANCE. MINIMIZING RISK FOR CHILDREN’S TOY LASER PRODUCTS. DEC 19, 2014.
US FDA. GUIDANCE. MINUTES OF INSTITUTIONAL REVIEW BOARD (IRB) MEETINGS. SEP 2017.
US FDA. GUIDANCE. MITIGATING THE RISK OF CROSS-CONTAMINATION FROM VALVES AND ACCESSORIES USED FOR IRRIGATION THROUGH FLEXIBLE GASTROINTESTINAL ENDOSCOPES. NOV 29, 2016.
US FDA. GUIDANCE. MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION : WHAT YOU NEED TO KNOW ABOUT THE FDA REGULATION. SMALL ENTITY COMPLIANCE GUIDE. AUG 2017.
US FDA. GUIDANCE. MIXING, DILUTING, OR REPACKAGING BIOLOGICAL PRODUCTS OUTSIDE THE SCOPE OF AN APPROVED BIOLOGICS LICNESE APPLICATION. JAN 2018.
US FDA. GUIDANCE. MODIFIED RELEASE VETERINARY PARENTERAL DOSAGE FORMS : DEVELOPMENT, EVALUATION, AND ESTABLISHMENT OF SPECIFICATIONS. JUN 2016.
US FDA. GUIDANCE. MOLECULAR DIAGNOSTIC INSTRUMENTS WITH COMBINED FUNCTIONS. NOV 12, 2014.
US FDA. GUIDANCE. MONOCLONAL ANTIBODIES USED AS REAGENTS IN DRUG MANUFACTURING. MAR 01, 2001.
US FDA. GUIDANCE. MOUSE EMBRYO ASSAY FOR ASSISTED REPRODUCTION TECHNOLOGY DEVICES. JAN 5, 2021.
US FDA. GUIDANCE. MULTIPLE ENDPOINTS IN CLINICAL TRIALS. OCT 2022.
US FDA. GUIDANCE. NASAL SPRAY AND INHALATION SOLUTION, SUSPENSION, AND SPRAY DRUG PRODUCTS-CHEMISTRY, MANUFACTURING, AND CONTROLS DOCUMENTATION. JUL 05, 2002.
US FDA. GUIDANCE. NATIONAL ENVIRONMENTAL POLICY ACT. ENVIRONMENTAL ASSESSMENTS FOR TOBACCO PRODUCTS. CATEGORICAL EXCLUSIONS. SMALL ENTITY COMPLIANCE GUIDE. OCT 2015.
US FDA. GUIDANCE. NATIONAL UNIFORMITY FOR NONPRESCIPTION DRUGS - INGREDIENT LISTING FOR OTC DRUGS. APR 09, 1998.
US FDA. GUIDANCE. NDAS: IMPURITIES IN DRUG SUBSTANCES. FEB 01, 2000.
US FDA. GUIDANCE. NECESSARY AUTOMATED EXTERNAL DEFIBRILLATOR ACCESSORIES : POLICY REGARDING COMPLIANCE DATE. OCT 28, 2020.
US FDA. GUIDANCE. NEEDLESTICKS - MEDICAL DEVICE REPORTING GUIDANCE FOR USER FACILITIES, MANUFACTURERS, AND IMPORTERS. NOV 11, 2002.
US FDA. GUIDANCE. NEGLECTED TROPICAL DISEASES OF THE DEVELOPING WORLD : DEVELOPING DRUGS FOR TREATMENT OR PREVENTION. JUL 2014.
US FDA. GUIDANCE. NEW ANIMAL DRUGS AND NEW ANIMAL DRUG COMBINATION PRODUCTS ADMINISTERED IN OR ON MEDICATED FEED OR DRINKING WATER OF FOOD-PRODUCING ANIMALS : RECOMMENDATIONS FOR DRUG SPONSORS FOR VOLUNTARILY ALIGNING PRODUCT USE CONDITIONS WITH CFI #209. DEC 2013.
US FDA. GUIDANCE. NEW CHEMICAL ENTITY EXCLUSIVITY DETERMINATIONS FOR CERTAIN FIXED-COMBINATION DRUG PRODUCTS. OCT 2014.
US FDA. GUIDANCE. NEW CONTRAST IMAGING INDICATION CONSIDERATIONS FOR DEVICES AND APPROVED DRUG AND BIOLOGICAL PRODUCTS. DEC 2009.
US FDA. GUIDANCE. NOISE CLAIMS IN HEARING AID LABELING. OCT 20, 1998.
US FDA. GUIDANCE. NON-AUTOMATED SPHYGMOMANOMETER (BLOOD PRESSURE CUFF) GUIDANCE - VERSION 1 . NOV 18, 1998.
US FDA. GUIDANCE. NON-CLINICAL ENGINEERING TESTS AND RECOMMENDED LABELING FOR INTRAVASCULAR STENTS AND ASSOCIATED DELIVERY SYSTEMS. APR 18, 2010.
US FDA. GUIDANCE. NON-CLINICAL INFORMATION FOR FEMORAL STEM PROSTHESES. SEP 17, 2007.
US FDA. GUIDANCE. NON-INFERIORITY CLINICAL TRIALS TO ESTABLISH EFFECTIVENESS. NOV 2016.
US FDA. GUIDANCE. NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR GUIDANCE. MAR 09, 1997.
US FDA. GUIDANCE. NON-LOCAL IRB REVIEW . JAN 01, 1998.
US FDA. GUIDANCE. NONALLERGIC RHINITIS : DEVELOPING DRUG PRODUCTS FOR TREATMENT. SEP 2018.
US FDA. GUIDANCE. NONBINDING FEEDBACK AFTER CERTAIN FDA INSPECTIONS OF DEVICE ESTABLISHMENTS. APR 22, 2020.
US FDA. GUIDANCE. NONCLINICAL CONSIDERATIONS FOR MITIGATING NONHUMAN PRIMATE SUPPLY CONSTRAINTS ARISING FROM THE COVID-19 PANDEMIC. FEB 2022.
US FDA. GUIDANCE. NONCLINICAL EVALUATION OF ENDOCRINE-RELATED DRUG TOXICITY. SEP 2015.
US FDA. GUIDANCE. NONCLINICAL EVALUATION OF LATE RADIATION TOICITY OF THERAPEUTIC RADIOPHARMACEUTICALS. NOV 2011.
US FDA. GUIDANCE. NONCLINICAL PHARMACOLOGY/TOXICOLOGY DEVELOPMENT OF TOPICAL DRUGS INTENDED TO PREVENT THE TRANSMISSION OF SEXUALLY TRANSMITTED DISEASES (STD) AND/OR FOR THE DEVELOPMENT OF DRUGS INTENDED TO ACT AS VAGINAL CONTRACEPTIVES. JUN 30, 2005.
US FDA. GUIDANCE. NONCLINICAL SAFETY EVALUATION OF DRUG OR BIOLOGIC COMBINATIONS. MAR 15, 2006.
US FDA. GUIDANCE. NONCLINICAL SAFETY EVALUATION OF PEDIATRIC DRUG PRODUCTS. FEB 15, 2006.
US FDA. GUIDANCE. NONCLINICAL SAFETY EVALUATION OF REFORMULATE DDRUG PRODUCTS AND PRODUCTS INTENDED FOR ADMINISTRATION BY AN ALTERNATE ROUTE. OCT 2015.
US FDA. GUIDANCE. NONCLINICAL STUDIES FOR THE SAFETY EVALUATION OF PHARMACEUTICAL EXCIPIENTS. MAY 19, 2005.
US FDA. GUIDANCE. NONCLINICAL TESTING OF ORALLY INHALED NICOTINE-CONTAINING DRUG PRODUCTS. OCT 2020.
US FDA. GUIDANCE. NONMETASTATIC CASTRATION - RESISTANT PROSTATE CANCER : CONSIDERATIONS FOR METASTASIS-FREE SURVIVAL ENDPOINT IN CLINICAL TRIALS. AUG 2021.
US FDA. GUIDANCE. NONPRESCRIPTION SUNSCREEN DRUG PRODUCTS - FORMAT AND CONTENT OF DATA SUBMISSIONS. NOV 2016.
US FDA. GUIDANCE. NONPRESCRIPTION SUNSCREEN DRUG PRODUCTS - SAFETY AND EFFECTIVENESS DATA. NOV 2016.
US FDA. GUIDANCE. NONPROPRIETARY NAMING OF BIOLOGICAL PRODUCTS. JAN 2017.
US FDA. GUIDANCE. NOTICE TO GROWERS, FOOD MANUFACTURERS, FOOD WAREHOUSE MANAGERS, AND TRANSPORTERS OF FOOD PRODUCTS ON DECONTAMINATION OF TRANSPORT VEHICLES. NOV 01, 2005.
US FDA. GUIDANCE. NOTIFICATION OF A HEALTH CLAIM OR NUTRIENT CONTENT CLAIM BASED ON AN AUTHORITATIVE STATEMENT OF A SCIENTIFIC BODY. JUN 11, 1998.
US FDA. GUIDANCE. NOTIFYING CDRH OF A PERMANENT DISCONTINUANCE OR INTERRUPTION IN MANUFACTURING OF A DEVICE UNDER SECTION 506J OF THE FD&C ACT DURING THE COVID-19 PUBLIC HEALTH EMERGENCY (REVISED). NOV 2020.
US FDA. GUIDANCE. NOTIFYING FDA OF A PERMANENT DISCONTINUANCE OR INTERRUPTION IN MANUFACTURING UNDER SECTION 506C OF THE FD&C ACT. MAR 2020.
US FDA. GUIDANCE. NOTIFYING FDA OF FATALITIES RELATED TO BLOOD COLLECTION OR TRANSFUSION. AUG 2021.
US FDA. GUIDANCE. NUCLEAR PHARMACY GUIDELINE CRITERIA FOR DETERMINING WHEN TO REGISTER AS A DRUG ESTABLISHMENT. MAY 01, 1984.
US FDA. GUIDANCE. NUCLEIC ACID TESTING (NAT) FOR HUMAN IMMUNODEFICIENCY VIRTUS TYPE 1 (HIV-1) AND HEPATITIS C VIRUS (HCV)S : TESTING, PRODUCT DISPOSITION, AND DONOR DEFERRAL AND REENTRY. DEC 2017.
US FDA. GUIDANCE. NUCLEIC ACID TESTING (NAT) TO REDUCE THE POSSIBLE RISK OF HUMAN PARVOVIRUS B19 TRANSMISSION BY PLASMA-DERIVED PRODUCTS. JUL 2009.
US FDA. GUIDANCE. NUTRITION AND SUPPLEMENT FACTS LABELS : QUESTIONS AND ANSWERS RELATED TO THE COMPLIANCE DATE, ADDED SUGARS, AND DECLARATION OF QUANTITATIVE AMOUNTS OF VITAMINS AND MINERALS. REVISED. DEC 2019.
US FDA. GUIDANCE. NUTRITION LABELING OF STANDARD MENU ITEMS IN RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS. SMALL ENTITY COMPLIANCE GUIDE. MAR 2015.
US FDA. GUIDANCE. OFF-THE-SHELF SOFTWARE USE IN MEDICAL DEVICES. SEP 27, 2019.
US FDA. GUIDANCE. ON THE CONTENT AND FORMAT OF CHEMISTRY, MANUFACTURING AND CONTROLS INFORMATION AND ESTABLISHMENT DESCRIPTION INFORMATION FOR AN ALLERGENIC EXTRACT OR ALLERGEN PATCH TEST. APR 23, 1999.
US FDA. GUIDANCE. ONCOLOGIC DRUGS ADVISORY COMMITTEE DISCUSSION ON FDA REQUIREMENTS OR APPROVAL OF NEW DRUGS FOR TREATMENT OF COLON AND RECTAL CANCER. MAR 02, 1998.
US FDA. GUIDANCE. ONCOLOGY DRUGS FOR COMPANION ANIMALS. #237. AUG 2017.
US FDA. GUIDANCE. ONCOLOGY PHARMACEUTICALS : REPRODUCTIVE TOXICITY TESTING AND LABELING RECOMMENDATIONS. MAY 2019.
US FDA. GUIDANCE. ONCOLOGY THERAPEUTIC RADIOPHARMACEUTICALS : NONCLINICAL STUDIES AND LABELING RECOMMENDATIONS. AUG 2019.
US FDA. GUIDANCE. OPEN DOOR OPERATION OF MICROWAVE OVENS AS A RESULT OF OVEN MISWIRING. MAR 28, 1980.
US FDA. GUIDANCE. OPIOID USE DISORDER : DEVELOPING DEPOT BUPRENORPHINE PRODUCTS. FEB 2019.
US FDA. GUIDANCE. OPIOID USE DISORDER : ENDPOINTS FOR DEMONSTRATING EFFECTIVENESS OF DRUGS FOR TREATMENT. OCT 2020.
US FDA. GUIDANCE. ORALLY DISINTEGRATING TABLETS. DEC 2008.
US FDA. GUIDANCE. ORALLY INHALED AND INTRANASAL ORTICOSTEROIDS : EVALUATION OF THE EFFECTS ON GROWTH IN CHILDREN. MAR 2007.
US FDA. GUIDANCE. ORANGE BOOK. QUESTIONS AND ANSWERS. JUL 2022.
US FDA. GUIDANCE. ORGAN-SPECIFIC WARNINGS : INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE - LABELING FOR PRODUCTS THAT CONTAIN ACETAMINOPHEN. NOV 2015.
US FDA. GUIDANCE. ORGAN-SPECIFIC WARNINGS : INTERNAL ANALGESIC, ANTIPYRETIC, AND ANTIRHEUMATIC DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE. SMALL ENTITY COMPLIANCE GUIDE. JUL 2010.
US FDA. GUIDANCE. ORTHOPEDIC FRACTURE FIXATION PLATES - PERFORMANCE CRITERA FOR SAFETY AND PERFORMANCE BASED PATHWAY. APR 11, 2022.
US FDA. GUIDANCE. ORTHOPEDIC NON-SPINAL METALLIC BONE SCREWS AND WASHERS - PERFORMANCE CRITERIA FOR SAFETY AND PERFORMANCE BASED PATHWAY. DEC 11, 2020.
US FDA. GUIDANCE. OSTEOPOROSIS : NONCLINICAL EVALUATION OF DRUGS INTENDED FOR TREATMENT. AUG 2019.
US FDA. GUIDANCE. OTC DENTURE CUSHIONS, PADS, RELINERS, REPAIR KITS, AND PARTIALLY FABRICATED DENTURE KITS . AUG 17, 1998.
US FDA. GUIDANCE. OVER-THE-COUNTER PEDIATRIC ORAL LIQUID DRUG PRODUCTS CONTAINING ACETAMINOPHEN. AUG 2015.
US FDA. GUIDANCE. OVERSIGHT OF CLINICAL INVESTIGATIONS. A RISK-BASED APPROACH TO MONITORING. AUG 2013.
US FDA. GUIDANCE. PAC-ATLS: POSTAPPROVAL CHANGES - ANALYTICAL TESTING LABORATORY SITES. APR 28, 1998.
US FDA. GUIDANCE. PART 11, ELECTRONIC RECORDS. ELECTRONIC SIGNATURES - SCOPE AND APPLICATION.. SEP 05, 2003.
US FDA. GUIDANCE. PAT — A FRAMEWORK FOR INNOVATIVE PHARMACEUTICAL DEVELOPMENT, MANUFACTURING, AND QUALITY ASSURANCE. OCT 04, 2004.
US FDA. GUIDANCE. PATHOLOGICAL COMPLETE RESPONSE IN NEOADJUVANT TREATMENT OF HIGH-RISK EARLY-STAGE BREAST CANCER : USE AS AN ENDPOINT TO SUPPORT ACCELERATED APPROVAL. JUL 2020.
US FDA. GUIDANCE. PATIENT COUNSELING INFORMATION SECTION OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. DEC 2014.
US FDA. GUIDANCE. PATIENT ENGAGEMENT IN THE DESIGN AND CONDUCT OF MEDICAL DEVICE CLINICAL STUDIES. JAN 26, 2022.
US FDA. GUIDANCE. PATIENT PREFERENCE INFORMATION - VOLUNTARY SUBMISSION, REVIEW IN PREMARKET APPROVAL APPLICATIONS, HUMANITARIAN DEVICE EXEMPTION APPLICATIONS, AND DE NOVO REQUESTS, AND INCLUSION IN DECISION SUMMARIES AND DEVICE LABELING. AUG 24, 2016.
US FDA. GUIDANCE. PATIENT-FOCUSED DRUG DEVELOPMENT : COLLECTING COMPREHENSIVE AND REPRESENTATIVE INPUT. JUN 2020.
US FDA. GUIDANCE. PATIENT-FOCUSED DRUG DEVELOPMENT : METHODS TO IDENTIFY WHAT IS IMPORTANT TO PATIENTS. FEB 2022.
US FDA. GUIDANCE. PATIENT-REPORTED OUTCOME MEASURES : USE IN MEDICAL PRODUCT DEVELOPMENT TO SUPPORT LABELING CLAIMS. DEC 2009.
US FDA. GUIDANCE. PAYMENT AND REIMBURSEMENT TO RESEARCH SUBJECTS. INFORMATION SHEET. JAN 2018.
US FDA. GUIDANCE. PEDIATRIC EXPERTISE FOR ADVISORY PANELS. JUN 02, 2003.
US FDA. GUIDANCE. PEDIATRIC HIV INFECTION : DRUG PRODUCT DEVELOPMENT FOR TREATMENT. MAR 2019.
US FDA. GUIDANCE. PEDIATRIC INFORMATION FOR X-RAY IMAGING PDEVICE PREMARKET NOTIFICATIONS. NOV 28, 2017.
US FDA. GUIDANCE. PEDIATRIC INFORMATION INCORPORATED INTO HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCT LABELING. MAR 2019.
US FDA. GUIDANCE. PEDIATRIC STUDY PLANS : CONTENT OF AND PROCESS FOR SUBMITTING INITIAL PEDIATRIC STUDY PLANS AND AMENDED INITIAL PEDIATRIC STUDY PLANS. JUL 2020.
US FDA. GUIDANCE. PERFORMANCE STANDARD FOR DIAGNOSTIC X-RAY SYSTEMS AND THEIR MAJOR COMPONENTS (21CFR1020.30, 1020.31, 1020.32, 1020.33). SMALL COMPLIANCE GUIDE. FEB 21, 2023.
US FDA. GUIDANCE. PERIPHERAL VASCULAR ATHERECTOMY DEVICES - PREMARKET NOTIFICATION [510(K)] SUBMISSIONS. MAY 20, 2021.
US FDA. GUIDANCE. PET DRUG APPLICATIONS - CONTENT AND FORMAT FO RNDAS AND ANDAS. FLUDEOXYGLUCOSE F 18 INJECTION. AMMONIA N 13 INJECTION. SODIUM FLUORIDE F 18 INJECTION. AUG 2011.
US FDA. GUIDANCE. PET DRUGS - CURRENT GOOD MANUFACTURING PRACTICE (CGMP). AUG 2011.
US FDA. GUIDANCE. PET DRUGS - CURRENT GOOD MANUFACTURING PRACTICE (CGMP). DEC 2009.
US FDA. GUIDANCE. PHARMACEUTICAL COMPONENTS AT RISK FOR MELAMINE CONTAMINATION. AUG 2009.
US FDA. GUIDANCE. PHARMACOGENETIC TESTS AND GENETIC TESTS FOR HERITABLE MARKERS. FEB 09, 2006.
US FDA. GUIDANCE. PHARMACOKINETIC-BASED CRITERIA FOR SUPPORTING ALTERNATIVE DOSING REGIMENS OF PROGRAMMED CELL DEATH RECEPTOR-1 (PD-1) OR PROGRAMMED CELL DEATH-LIGAND 1 (PD-L1) BLOCKING ANTIBODIES FOR TREATMENT OF PATIENTS WITH CANCER. DEC 2022.
US FDA. GUIDANCE. PHARMACOKINETICS IN PATIENTS WITH IMPAIRED HEPATIC FUNCTION: STUDY DESIGN, DATA ANALYSIS, AND IMPACT ON DOSING AND LABELING. MAY 30, 2003.
US FDA. GUIDANCE. PHARMACOVIGILANCE OF VETERINARY MEDICINAL PRODUCT. ELECTRONIC STANDARDS FOR TRANSFER OF DATA. VICH GL35. #214. DEC 2014.
US FDA. GUIDANCE. PHARMACOVIGILANCE OF VETERINARY MEDICINAL PRODUCTS : CONTROLLED LIST OF TERMS. VICH GL30. #143. OCT 2014.
US FDA. GUIDANCE. PHARMACY COMPOUNDING OF HUMAN DRUG PRODUCTS UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. JUN 2016. REV. 2.
US FDA. GUIDANCE. PHS GUIDELINE ON INFECTIOUS DISEASE ISSUES IN XENOTRANSPLANTATION: PHS GUIDELINE. JAN 19, 2001.
US FDA. GUIDANCE. PHYSIOLOGICALLY BASED PHARMACOKINETIC ANALYSES - FORMAT AND CONTENT. AUG 2018.
US FDA. GUIDANCE. PLACEBOS AND BLINDING IN RANDOMIZED CONTROLLED CANCER CLINICAL TRIALS FOR DRUG AND BIOLOGICAL PRODUCTS. AUG 2019.
US FDA. GUIDANCE. PLANNING FOR THE EFFECTS OF HIGH ABSENTEEISM TO ENSURE AVAILABILITY OF MEDICALLY NECESSARY DRUG PRODUCTS. MAR 2011.
US FDA. GUIDANCE. PLASMA DERIVED FROM THERAPEUTIC PLASMA EXCHANGE. DEC 14, 1984.
US FDA. GUIDANCE. POINTS TO CONSIDER FOR CERVICAL CYTOLOGY DEVICES. JUL 25, 1994.
US FDA. GUIDANCE. POINTS TO CONSIDER IN THE MANUFACTURE AND TESTING OF MONOCLONAL ANTIBODY PRODUCTS FOR HUMAN USE. FEB 28, 1997.
US FDA. GUIDANCE. POLICY CLARIFICATION FOR CERTAIN FLUROSCOPIC EQUIPMENT REQUIREMENTS. MAY 8, 2019.
US FDA. GUIDANCE. POLICY FOR CERTAIN REMS REQUIREMENTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. MAR 2020.
US FDA. GUIDANCE. POLICY FOR CERTAIN REMS REQUIREMENTS DURING THE TOCILIZUMAB SHORTAGE RELATED TO THE COVID-19 PUBLIC HEALTH EMERGENCY. DEC 2021.
US FDA. GUIDANCE. POLICY FOR CORONAVIRUS DISEASE-2019 TESTS DURING THE PUBLIC HEALTH EMERGENCY (REVISED). JAN 12, 2023.
US FDA. GUIDANCE. POLICY FOR DEVICE SOFTWARE FUNCTIONS AND MOBILE MEDICAL APPLICATIONS. SEP 28, 2022.
US FDA. GUIDANCE. POLICY FOR EVALUATING IMPACT OF VIRAL MUTATIONS ON COVID-19 TESTS. JAN 12, 2023.
US FDA. GUIDANCE. POLICY FOR MONKEYPOX TESTS TO ADDRESS THE PUBLIC HEALTH EMERGENCY. SEP 7, 2022.
US FDA. GUIDANCE. POLICY FOR TESTING OF ALCOHOL (ETHANOL) AND ISOPROPYL ALCOHOL FOR METHANOL, INCLUDING DURING THE PUBLIC HEALTH EMERGENCY (COVID-19). JAN 2021.
US FDA. GUIDANCE. POLICY FOR THE TEMPORARY USE OF PORTABLE CRYOGENIC CONTAINERS NOT IN COMPLIANCE WITH 21 CFR 211.94(E)(1) FOR OXYGEN AND NITROGEN DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. APR 20, 2020.
US FDA. GUIDANCE. POLICY ON LAMP COMPATIBILITY (SUNLAMPS). SEP 02, 1986.
US FDA. GUIDANCE. POLICY ON MAXIMUM TIMER INTERVAL AND EXPOSURE SCHEDULE FOR SUNLAMP PRODUCTS. AUG 21, 1985.
US FDA. GUIDANCE. POLICY ON WARNING LABEL REQUIRED ON SUNLAMP PRODUCTS. JUN 25, 1985.
US FDA. GUIDANCE. POLICY REGARDING CERTAIN ENTITIES SUBJECT TO THE CURRENT GOOD MANUFACTURING PRACTICE AND PREVENTIVE CONTROLS, PRODUCE SAFETY, AND/OR FOREIGN SUPPLIER VERIFICATION PROGRAMS. JAN 2018.
US FDA. GUIDANCE. POLICY REGARDING N-ACETYL-L-CYSTEINE. AUG 2022.
US FDA. GUIDANCE. POLICY RELATED TO CRANBERRY PRODUCTS WITH ADDED FLAVORINGS. AUG 2019.
US FDA. GUIDANCE. POPULATION PHARMACOKINETICS. FEB 2022.
US FDA. GUIDANCE. POSSIBLE DIOXIN/PCB CONTAMINATION OF DRUG AND BIOLOGICAL PRODUCTS. AUG 23, 1999.
US FDA. GUIDANCE. POST-COMPLETE RESPONSE LETTER TELECONFERENCES BETWEEN FDA AND ANDA APPLICATIONS UNDER GDUFA. OCT 2022. REV. 1.
US FDA. GUIDANCE. POSTMARKET MANAGEMENT OF CYBERSECURITY IN MEDICAL DEVICES. DEC 28, 2016.
US FDA. GUIDANCE. POSTMARKET SURVEILLANCE UNDER SECTION 522 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. OCT 7, 2022.
US FDA. GUIDANCE. POSTMARKETING ADVERSE EVENT REPORTING FOR MEDICAL PRODUCTS AND DIETARY SUPPLEMENTS DURING A PANDEMIC. MAY 2020.
US FDA. GUIDANCE. POSTMARKETING ADVERSE EVENT REPORTING FOR NONPRESCRIPTION HUMAN DRUG PRODUCTS MARKETED WITHOUT AN APPROVED APPLICATION. JUL 2009.
US FDA. GUIDANCE. POSTMARKETING ADVERSE EXPERIENCE REPORTING FOR HUMAN DRUG AND LICENSED BIOLOGICAL PRODUCTS: CLARIFICATION OF WHAT TO REPORT. AUG 27, 1997.
US FDA. GUIDANCE. POSTMARKETING SAFETY REPORTING FOR COMBINATION PRODUCTS. JUL 2019.
US FDA. GUIDANCE. POSTMARKETING STUDIES AND CLINICAL TRIALS - IMPLEMENTATION OF SECTION 505(O)(3) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. APR 2011.
US FDA. GUIDANCE. POTASSIUM IODIDE AS A THYROID BLOCKING AGENT IN RADIATION EMERGENCIES. DEC 11, 2001.
US FDA. GUIDANCE. POTASSIUM IODIDE TABLETS - SHELF LIFE EXTENSION. MAR 08, 2004.
US FDA. GUIDANCE. POTENCY TESTS FOR CELLULAR AND GENE THERAPY PRODUCTS. JAN 2011.
US FDA. GUIDANCE. PRACTICES TO PREVENT UNSAFE CONTAMINATION OF ANIMAL FEED FROM DRUG CARRYOVER. #272. JAN 2023.
US FDA. GUIDANCE. PRE-CLINICAL AND CLINICAL STUDIES FOR NEUROTHROMBECTOMY DEVICES. JUN 18, 2007.
US FDA. GUIDANCE. PRE-LAUNCH ACTIVITIES IMPORTATION REQUESTS (PLAIR). MAR 2022.
US FDA. GUIDANCE. PRE-PETITION CONSULTATIONS FOR FOOD ADDITIVES AND COLOR ADDITIVES. APR 01, 2005.
US FDA. GUIDANCE. PRE-STORAGE LEUKOCYTE REDUCTION OF WHOLE BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION. SEP 2012.
US FDA. GUIDANCE. PRE-SUBMISSION CONSULTATION PROCESS FOR ANIMAL FOOD ADDITIVE PETITIONS OR GENERALLY RECOGNIZED AS SAFE (GRAS) NOTICES. #262. DEC 2020.
US FDA. GUIDANCE. PRECLINICAL ASSESSMENT OF INVESTIGATIONAL CELLULAR AND GENE THERAPY PRODUCTS. NOV 2013.
US FDA. GUIDANCE. PREGNANCY, LACTATION, AND REPRODUCTIVE POTENTIAL : LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. SMALL ENTITY COMPLIANCE. GUIDE. JUN 2015.
US FDA. GUIDANCE. PREMARKET APPROVAL APPLICATION MODULAR REVIEW. NOV 03, 2003.
US FDA. GUIDANCE. PREMARKET NOTIFICATION - CONSISTENCY OF REVIEWS #K89-1 (BLUE BOOK MEMO). FEB 27, 1989.
US FDA. GUIDANCE. PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR BIPOLAR ELECTROSURGICAL VESSEL SEALERS FOR GENERAL SURGERY. AUG 15, 2016.
US FDA. GUIDANCE. PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR ELECTROSURGICAL DEVICES FOR GENERAL SURGERY. MAR 9, 2020.
US FDA. GUIDANCE. PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR ULTRASONIC DIATHERMY DEVICES. FEB 21, 2023.
US FDA. GUIDANCE. PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR CHEMICAL INDICATORS . DEC 18, 2003.
US FDA. GUIDANCE. PREMARKET NOTIFICATION [510(K)] SUBMISSIONS FOR TESTING FOR SKIN SENSITIZATION TO CHEMICALS IN NATURAL RUBBER PRODUCTS.. JAN 12, 1999.
US FDA. GUIDANCE. PREMARKET NOTIFICATION REQUIREMENTS CONCERNING GOWNS INTENDED FOR USE IN HEALTH CARE SETTINGS. DEC 9, 2015.
US FDA. GUIDANCE. PREMARKET NOTIFICATION SUBMISSIONS FOR BLOOD AND PLASMA WARMERS. JUL 19, 2001.
US FDA. GUIDANCE. PREMARKET NOTIFICATION SUBMISSIONS FOR EMPTY CONTAINERS FOR THE COLLECTION AND PROCESSING OF BLOOD AND BLOOD COMPONENTS. JUL 19, 2001.
US FDA. GUIDANCE. PREMARKET NOTIFICATION SUBMISSIONS FOR TRANSFER SETS (EXCLUDING STERILE CONNECTING DEVICES). JUL 19, 2001.
US FDA. GUIDANCE. PREMARKET STUDIES OF IMPLANTABLE MINIMALLY INVASIVE GLAUCOMA SURGICAL (MIGS) DEVICES. DEC 15, 2015.
US FDA. GUIDANCE. PREMARKET TOBACCO PRODUCT APPLICATIONS FOR ELECTRONIC NICOTINE DELIVERY SYSTEMS (REVISED)*. MAR 2023.
US FDA. GUIDANCE. PREMARKETING RISK ASSESSMENT. MAR 29, 2005.
US FDA. GUIDANCE. PREMENOPAUSAL WOMEN WITH BREAST CANCER : DEVELOPING DRUGS FOR TREATMENT. JUN 2021.
US FDA. GUIDANCE. PREPARATION AND REVIEW OF INVESTIGATIONAL DEVICE EXEMPTION APPLICATIONS (IDES) FOR TOTAL ARTIFICIAL DISCS. APR 11, 2008.
US FDA. GUIDANCE. PREPARATION OF FOOD CONTACT NOTIFICATIONS FOR FOOD CONTACT SUBSTANCES IN CONTACT WITH INFANT FORMULA AND/OR HUMAN MILK. MAY 2019.
US FDA. GUIDANCE. PREPARATION OF FOOD CONTACT SUBSTANCE NOTIFICATIONS (ADMINISTRATIVE). OCT 2021.
US FDA. GUIDANCE. PREPARATION OF FOOD CONTACT SUBSTANCE NOTIFICATIONS (TOXICOLOGY RECOMMENDATIONS). OCT 2021.
US FDA. GUIDANCE. PREPARATION OF IDES AND INDS FOR PRODUCTS INTENDED TO REPAIR OR REPLACE KNEE CARTILAGE. DEC 2011.
US FDA. GUIDANCE. PREPARATION OF INVESTIGATIONAL NEW DRUG PRODUCTS (HUMAN AND ANIMAL). NOV 01, 1992.
US FDA. GUIDANCE. PREPARATION OF PREMARKET SUBMISSIONS FOR FOOD CONTACT SUBSTANCES (CHEMISTRY RECOMMENDATIONS). DEC 2007.
US FDA. GUIDANCE. PREPARING A CLAIM OF CATEGORICAL EXCLUSION OR AN ENVIRONMENTAL ASSESSMENT FOR SUBMISSION TO CFSAN - APPENDIX A. MAY 01, 2006.
US FDA. GUIDANCE. PREPARING A CLAIM OF CATEGORICAL EXCLUSION OR AN ENVIRONMENTAL ASSESSMENT FOR SUBMISSION TO CFSAN - APPENDIX B. MAY 01, 2006.
US FDA. GUIDANCE. PREPARING A CLAIM OF CATEGORICAL EXCLUSION OR AN ENVIRONMENTAL ASSESSMENT FOR SUBMISSION TO CFSAN - APPENDIX C. MAY 16, 2006.
US FDA. GUIDANCE. PREPARING A CLAIM OF CATEGORICAL EXCLUSION OR AN ENVIRONMENTAL ASSESSMENT FOR SUBMISSION TO CFSAN - APPENDIX D. MAY 16, 2006.
US FDA. GUIDANCE. PREPARING A CLAIM OF CATEGORICAL EXCLUSION OR AN ENVIRONMENTAL ASSESSMENT FOR SUBMISSION TO CFSAN - APPENDIX E (40 CFR 1508.27). MAY 16, 2006.
US FDA. GUIDANCE. PREPARING A CLAIM OF CATEGORICAL EXCLUSION OR AN ENVIRONMENTAL ASSESSMENT FOR SUBMISSION TO CFSAN - ATTACHMENT 1. MAY 16, 2006.
US FDA. GUIDANCE. PREPARING A CLAIM OF CATEGORICAL EXCLUSION OR AN ENVIRONMENTAL ASSESSMENT FOR SUBMISSION TO CFSAN - ATTACHMENT 2. MAY 16, 2006.
US FDA. GUIDANCE. PREPARING A CLAIM OF CATEGORICAL EXCLUSION OR AN ENVIRONMENTAL ASSESSMENT FOR SUBMISSION TO CFSAN. MAY 16, 2006.
US FDA. GUIDANCE. PREPARING A COLOR ADDITIVE PETITION FOR SUBMISSION TO THE CENTER FOR FOOD SAFETY AND APPLIED NUTRITION FOR COLOR ADDITIVES USED IN OR ON CONTACT LENSES. MAY 01, 2006.
US FDA. GUIDANCE. PREPARING NOTICES OF AVAILABILITY OF INVESTIGATIONAL MEDICAL DEVICES AND FOR RECRUITING STUDY SUBJECTS. MAR 19, 1999.
US FDA. GUIDANCE. PRESCRIPTION DRUG MARKETING ACT — DONATION OF PRESCRIPTION DRUG SAMPLES TO FREE CLINICS. MAR 14, 2006.
US FDA. GUIDANCE. PRESCRIPTION DRUG MARKETING ACT (PDMA) REQUIREMENTS. QUESTIONS AND ANSWERS. NOV 2006.
US FDA. GUIDANCE. PRESCRIPTION DRUG USER FEE ACT WAIVERS, REDUCTIONS, AND REFUNDS FOR DRUG AND BIOLOGICAL PRODUCTS. OCT 2019.
US FDA. GUIDANCE. PRESCRIPTION REQUIREMENT UNDER SECTION 503A OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. DEC 2016.
US FDA. GUIDANCE. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING PRODUCTION, STORAGE, AND TRANSPORTATION (LAYERS WITH ACCESS TO AREAS OUTSIDE THE POULTRY HOUSE): QUESTIONS AND ANSWERS REGARDING THE FINAL RULE.. AUG 2022.
US FDA. GUIDANCE. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING PRODUCTION, STORAGE, AND TRANSPORTATION. DEC 2011.
US FDA. GUIDANCE. PRINCIPLES FOR SELECTING, DEVELOPING, MODIFYING, AND ADAPTING PATIENT-RELATED OUTCOME INSTRUMENTS FOR USE IN MEDICAL DEVICE EVALUATION. JAN 26, 2022.
US FDA. GUIDANCE. PRINCIPLES OF PREMARKET PATHWAYS FOR COMBINATION PRODUCTS. JAN 2022.
US FDA. GUIDANCE. PRIOR NOTICE OF IMPORTED FOOD CONTINGENCY PLAN FOR SYSTEM OUTAGES. NOV 2020.
US FDA. GUIDANCE. PROCEDURES FOR CLASS II DEVICE EXEMPTIONS FROM PREMARKET NOTIFICATION. FEB 18, 1998.
US FDA. GUIDANCE. PROCEDURES FOR FIELD TESTING MICROWAVE OVENS. AUG 01, 1977.
US FDA. GUIDANCE. PROCEDURES FOR HANDLING POST-APPROVAL STUDIES IMPOSED BY PREMARKET APPROVAL APPLICATION ORDER. OCT 7, 2022.
US FDA. GUIDANCE. PROCEDURES FOR LABORATORY TESTING OF MICROWAVE OVENS. OCT 01, 1981.
US FDA. GUIDANCE. PROCEDURES FOR MEETINGS OF THE MEDICAL DEVICES ADVISORY COMMITTEE. SEP 1, 2017.
US FDA. GUIDANCE. PROCEDURES FOR RENEWAL AND AMENDMENT OF CERTAIN LASER LIGHT SHOW VARIANCES (LASER NOTICE 55). SEP 25, 2007.
US FDA. GUIDANCE. PROCESS FOR HANDLING REFERRALS TO FDA UNDER 21 CFR 50.54. ADDITIONAL SAFEGUARDS FOR CHILDREN IN CLINICAL INVESTIGATIONS. DEC 2006.
US FDA. GUIDANCE. PROCESS TO REQUEST A REVIEW OF FDA’S DECISION NOT TO ISSUE CERTAIN EXPORT CERTIFICATES FOR DEVICES. NOV 6, 2020.
US FDA. GUIDANCE. PROCESS VALIDATION : GENERAL PRINCIPLES AND PRACTICE. JAN 2011. REV. 1.
US FDA. GUIDANCE. PRODUCT DEVELOPMENT UNDER THE ANIMAL RULE. OCT 2015.
US FDA. GUIDANCE. PRODUCT IDENTIFERS UNDER THE DRUG SUPPLY CHAIN SECURITY ACT. QUESTIONS AND ANSWERS. JUN 2021.
US FDA. GUIDANCE. PRODUCT IDENTIFIER REQUIREMENTS UNDER THE DRUG SUPPLY CHAIN SECURITY ACT - COMPLIANCE POLICY. SEP 2018.
US FDA. GUIDANCE. PRODUCT LABELING FOR CERTAIN ULTRASONIC SURGICAL ASPIRATOR DEVICES. OCT 30, 2017.
US FDA. GUIDANCE. PRODUCT LABELING FOR LAPAROSCOPIC POWER MORCELLATORS. DEC 30, 2020.
US FDA. GUIDANCE. PRODUCT NAME PLACEMENT, SIZE, AND PROMINENCE IN PROMOTIONAL LABELING AND ADVERTISEMENTS. DEC 2017.
US FDA. GUIDANCE. PRODUCT RECALLS, INCLUDING REMOVALS AND CORRECTIONS. MAR 2020.
US FDA. GUIDANCE. PRODUCT SAFETY RULE : ENFORCEMENT POLICY FOR ENTITIES GROWING, HARVESTING, PACKING, OR HOLDING HOPS, WINE GRAPES, PULSE CROPS, AND ALMONDS. MAR 2019.
US FDA. GUIDANCE. PROPER LABELING OF HONEY AND HONEY PRODUCTS. FEB 2018.
US FDA. GUIDANCE. PROPOSED APPROACH TO REGULATION OF CELLULAR AND TISSUE-BASED PRODUCTS. FEB 28, 1997.
US FDA. GUIDANCE. PROPRIETARY NAMES FOR NEW ANIMAL DRUGS. #20. MAY 2020.
US FDA. GUIDANCE. PROSPECTIVE MANUFACTURERS OF BARRIER DEVICES USED DURING ORAL SEX FOR STD PROTECTION. OCT 30, 1996.
US FDA. GUIDANCE. PROTECTING PARTICIPANTS IN BIOEQUIVALENCE STUDIES FOR ABBREVIATED NEW DRUG APPLICATIONS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. JAN 2021.
US FDA. GUIDANCE. PROTECTION OF HUMAN SUBJECTS: CATEGORIES OF RESEARCH THAT MAY BE REVIEWED BY THE INSTITUTIONAL REVIEW BOARD (IRB) THROUGH AN EXPEDITED REVIEW PROCEDURE. NOV 09, 1998.
US FDA. GUIDANCE. PROTOCOLS FOR THE CONDUCT OF METHOD TRANSFER STUDIES FOR TYPE C MEDICATED FEED ASSASY METHODS. #136. APR 26, 2007.
US FDA. GUIDANCE. PROVIDING CLINICAL EVIDENCE OF EFFECTIVENESS FOR HUMAN DRUG AND BIOLOGICAL PRODUCTS.. MAY 15, 1998.
US FDA. GUIDANCE. PROVIDING INFORMATION ABOUT PEDIATRIC USES OF MEDICAL DEVICES. MAY 1, 2014.
US FDA. GUIDANCE. PROVIDING LOT RELEASE PROTOCOL SUBMISSIONS TO THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) IN ELECTRONIC FORMAT. FEB 2019.
US FDA. GUIDANCE. PROVIDING POSTMARKETING PERIODIC SAFETY REPORTS IN THE ICH E2C(R2) FORMAT (PERIODIC BENEFIT-RISK EVALUATION REPORT). NOV 2016.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS FOR MEDICAL DEVICES IN ELECTRONIC FORMAT - SUBMISSIONS UNDER SECTION 745A(B) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. JUL 15, 2020.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ALTERNATE ELECTRONIC FORMAT. JUN 2022. REV 1.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC AND NON-ELECTRONIC FORMAT - PROMOTIONAL LABELING AND ADVERTISING MATERIALS FOR HUMAN PRESCRIPTION DRUGS. APR 2022.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT - CERTAIN HUMAN PHARMACEUTICAL PRODUCT APPLICATIONS AND RELATED SUBMISSIONS USING THE ECTD SPECIFICATIONS. FEB 2020.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT - CONTENT OF THE RISK EVALUATION AND MITIGATION STRATEGIES DOCUMENT USING STRUCTURED PRODUCT LABELING. DEC 2020.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT - DRUG ESTABLISHMENT REGISTRATION AND DRUG LISTING. MAY 2009.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT - RECEIPT DATES. FEB 2014.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT - STANDARDIZED STUDY DATA. JUN 2021. REV. 2.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT - SUBMISSIONS UNDER SECTION 745A (A) OF FFDC ACT. DEC 2014.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT — CONTENT OF LABELING. APR 21, 2005.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS IN ELECTRONIC FORMAT, GENERAL CONSIDERATIONS. JAN 28, 1999.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS TO CBER IN ELECTRONIC FORMAT INVESTIGATIONAL NEW DRUG APPLICATIONS (INDS) (PDF). MAR 01, 2002.
US FDA. GUIDANCE. PROVIDING REGULATORY SUBMISSIONS TO THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH (CBER) IN ELECTRONIC FORMAT - BIOLOGICS MARKETING APPLICATIONS. NOV 01, 1999.
US FDA. GUIDANCE. PROVIDING SUBMISSIONS IN ELECTRONIC FORMAT - POSTMARKET NON-EXPEDITED ICSRS. TECHNICAL QUESTIONS AND ANSWERS. JUL 2013.
US FDA. GUIDANCE. PROVIDING SUBMISSIONS IN ELECTRONIC FORMAT. POSTMARKETING SAFETY REPORTS FOR VACCINES. AUG 2015.
US FDA. GUIDANCE. PROVIDING SUBMISSIONS IN ELECTRONIC FORMAT. POSTMARKETING SAFETY REPORTS. APR 2022.
US FDA. GUIDANCE. PRUSSIAN BLUE DRUG PRODUCTS — SUBMITTING A NEW DRUG APPLICATION. FEB 04, 2003.
US FDA. GUIDANCE. PSYCHOACTIVE DRUGS IN INFANTS AND CHILDREN-CLINICAL EVALUATION. MAR 02, 1998.
US FDA. GUIDANCE. PUBLIC AVAILABILITY OF LISTS OF RETAIN CONSIGNEES TO EFFECTUATE CERTAIN HUMAN AND ANIMAL FOOD RECALLS. NOV 2020.
US FDA. GUIDANCE. PUBLIC NOTIFICATION OF EMERGING POSTMARKET MEDICAL DEVICE SIGNALS (“EMERGING SIGNALS”). DEC 14, 2016.
US FDA. GUIDANCE. PUBLIC WARNING AND NOTIFICATION OF RECALLS UNDER 21 CFR PART 7, SUBPART C. FEB 2019.
US FDA. GUIDANCE. PULSE OXIMETERS - PREMARKET NOTIFICATION SUBMISSIONS (510(K)S). MAR 4, 2013.
US FDA. GUIDANCE. PYROGEN AND ENDOTOXINS TESTING : QUESTIONS AND ANSWERS. JUN 2012.
US FDA. GUIDANCE. Q10 PHARMACEUTICAL QUALITY SYSTEM. APR 2009.
US FDA. GUIDANCE. Q11 DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES (CHEMICAL ENTITIES AND BIOTECHNOLOGICAL / BIOLOGICAL ENTITIES). QUESTIONS AND ANSWERS. FEB 2018.
US FDA. GUIDANCE. Q11 DEVELOPMENT AND MANUFACTURE OF DRUG SUBSTANCES. NOV 2012.
US FDA. GUIDANCE. Q12 TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT - ANNEXES. MAY 2021.
US FDA. GUIDANCE. Q12 TECHNICAL AND REGULATORY CONSIDERATIONS FOR PHARMACEUTICAL PRODUCT LIFECYCLE MANAGEMENT. MAY 2021.
US FDA. GUIDANCE. Q13 GUIDELINE. CONTINUOUS MANUFACTURING OF DRUG SUBSTANCES AND DRUG PRODUCTS. MAR 2023.
US FDA. GUIDANCE. Q1A(R2) STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS. NOV 21, 2003.
US FDA. GUIDANCE. Q1C STABILITY TESTING FOR NEW DOSAGE FORMS. MAY 09, 1997.
US FDA. GUIDANCE. Q1D BRACKETING AND MATRIXING DESIGNS FOR STABILITY TESTING OF NEW DRUG SUBSTANCES AND PRODUCTS. JAN 16, 2003.
US FDA. GUIDANCE. Q1E EVALUATION OF STABILITY DATA. JUN 08, 2004.
US FDA. GUIDANCE. Q2(R1) VALIDATION OF ANALYTICAL PROCEDURES : TEXT AND METHODOLOGY. NOV 2005.
US FDA. GUIDANCE. Q2A TEXT ON VALIDATION OF ANALYTICAL PROCEDURES. MAR 01, 1995.
US FDA. GUIDANCE. Q2B VALIDATION OF ANALYTICAL PROCEDURES: METHODOLOGY. MAY 19, 1997.
US FDA. GUIDANCE. Q3A IMPURITIES IN NEW DRUG SUBSTANCES. JUN 2008. REV. 2.
US FDA. GUIDANCE. Q3B(R) IMPURITIES IN NEW DRUG PRODUCTS (REVISION 3). AUG 04, 2006.
US FDA. GUIDANCE. Q3C - TABLES AND LIST. AUG 2018.
US FDA. GUIDANCE. Q3C IMPURITIES: RESIDUAL SOLVENTS 2011. DEC 24, 1997.
US FDA. GUIDANCE. Q3C: APPENDIX 5. MAR 18, 1998.
US FDA. GUIDANCE. Q3C(R8) IMPURITIES : GUIDANCE FOR RESIDUAL SOLVENTS. DEC 2021.
US FDA. GUIDANCE. Q3D(R2) ELEMENTAL IMPURITIES. SEP 2022. REV. 2.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN HT EICH REGIONS. ANNEX 8(R1) STERILITY TEST. GENERAL CHAPTER. SEP 2017. REV. 1.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANEX 12. ANALYTICAL SIEVING. SEP 2010.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 1(R1) RESIDUE ON IGNITION-SULFATED ASH. GENERAL CHAPTER. SEP 2017. REV. 1.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 11. CAPILLARY ELECTROPHORESIS. SEP 2010.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 13. BULK DENSITY AND TAPPED DENSITY OF POWDERS GENERAL CHAPTER. MAY 2013.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 14. BACTERIAL ENDOTOXINS TEST GENERAL CHAPTER. OCT 2013.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 2(R1) TEST FOR EXTRACTABLE VOLUME OF PARENTERAL PREPARATIONS. SEP 2017.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 3(R1) TEST FOR PARTICULATE CONTAMINATION : SUBVISIBLE PARTICLES GENERAL CHAPTER. SEP 2017. REV. 1.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 4A(R1) MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS : MICROBIAL ENUMERATION TESTS. GENERAL CHAPTER. SEP 2010. REV. 1.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 4B(R1) MICROBIOLOGICAL EXAMINATION OF NONSTERILE PRODUCTS : TESTS FOR SPECIFIED MICROORGANISMS. GENERAL CHAPTER. SEP 2017. REV. 1.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 5(R1). DISINTEGRATION TEST CENERAL CHAPTER. SEP 2017. REV. 1.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 7(R2). DISSOLUTION TEST GENERAL CHAPTER. JUN 2011. REV. 2.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 9(R1). TABLET FRIABILITY GENERAL CHAPTER. SEP 2017. REV. 1.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. ANNEXT 6 - UNIFORMITY OF DOSAGE UNITS GENERAL CHAPTER. JUN 2014.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOEIAL TEXTS FOR USE IN THE ICH REGIONS. FEB 2008.
US FDA. GUIDANCE. Q4B EVALUATION AND RECOMMENDATION OF PHARMACOPOIEAL TEXTS FOR USE IN THE ICH REGIONS. ANNEX 10(R1) POLYACRYLAMIDE GEL ELECTROPHORESIS. SEP 2017. REV. 1.
US FDA. GUIDANCE. Q5B QUALITY OF BIOTECHNOLOGICAL PRODUCTS: ANALYSIS OF THE EXPRESSION CONSTRUCT IN CELLS USED FOR PRODUCTION OF R-DNA DERIVED PROTEIN PRODUCTS. FEB 23, 1996.|
US FDA. GUIDANCE. Q5C QUALITY OF BIOTECHNOLOGICAL PRODUCTS: STABILITY TESTING OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS. JUL 01, 1996.
US FDA. GUIDANCE. Q5D QUALITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS: DERIVATION AND CHARACTERIZATION OF CELL SUBSTRATES USED FOR PRODUCTION OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS.. SEP 21, 1998.
US FDA. GUIDANCE. Q5E COMPARABILITY OF BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS SUBJECT TO CHANGES IN THEIR MANUFACTURING PROCESS. JUN 30, 2005.
US FDA. GUIDANCE. Q6A SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR NEW DRUG SUBSTANCES AND NEW DRUG PRODUCTS : CHEMICAL SUBSTANCES. DEC 29, 2000.
US FDA. GUIDANCE. Q6B SPECIFICATIONS: TEST PROCEDURES AND ACCEPTANCE CRITERIA FOR BIOTECHNOLOGICAL/BIOLOGICAL PRODUCTS. AUG 18, 1999.
US FDA. GUIDANCE. Q7 GOOD MANUFACTURING PRACTICE GUIDANCE FOR ACTIVE PHARMACEUTICAL INGREDIENTS. SEP 2016. REV. 1.
US FDA. GUIDANCE. Q7 GOOD MANUFACTURING PRACTICE. GUIDANCE FOR ACTIVE PHARMACEUTICAL INGREDIENTS. QUESTIONS AND ANSWERS. APR 2018.
US FDA. GUIDANCE. Q8, Q9, & Q10. QUESTIONS AND ANSWERS. APPENDIX. Q&AS FROM TRAINING SESSIONS. JUL 2012.
US FDA. GUIDANCE. Q8, Q9, AND Q10. QUESTIONS AND ANSWERS (R4). NOV 2011. REV. 1.
US FDA. GUIDANCE. Q8(R2) PHARMACEUTICAL DEVELOPMENT. NOV 2009. REV. 2.
US FDA. GUIDANCE. QUALIFICATION OF BIOMARKER - PLASMA FIBRINOGEN IN STUDIES EXAMINING EXACERBATIONS AND/OR ALL-CAUSE MORTALITY IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE. SEP 2016.
US FDA. GUIDANCE. QUALIFICATION OF BIOMARKER - TOTAL KIDNEY VOLUME IN STUDIES FOR TREATMENT OF AUTOSOMAL DOMINANT POLYCYSTIC KIDNEY DISEASE. SEP 2016.
US FDA. GUIDANCE. QUALIFICATION OF MEDICAL DEVICE DEVELOPMENT TOOLS. AUG 10, 2017.
US FDA. GUIDANCE. QUALIFICATION PROCESS FOR DRUG DEVELOPMENT TOOLS. NOV 2020.
US FDA. GUIDANCE. QUALIFIED INFECTIOUS DISEASE PRODUCT DESIGNATION - QUESTIONS AND ANSWERS. MAY 2021.
US FDA. GUIDANCE. QUALITY ASSURANCE GUIDELINES FOR HEMODIALYSIS DEVICES. FEB 01, 1991.
US FDA. GUIDANCE. QUALITY ATTRIBUTE CONSIDERATIONS FOR CHEWABLE TABLETS. AUG 2018.
US FDA. GUIDANCE. QUALITY CONSIDERATIONS IN DEMONSTRATING BIOSIMILARITY OF A THERAPEUTIC PROTEIN PRODUCT OT A REFERENCE PRODUCT. APR 2015.
US FDA. GUIDANCE. QUALITY CONTROL GUIDE FOR SUNLAMP PRODUCTS (FDA 88-8234). MAR 01, 1988.
US FDA. GUIDANCE. QUALITY CONTROL PRACTICES FOR COMPLIANCE WITH THE FEDERAL LASER PERFORMANCE STANDARD. MAR 01, 1976.
US FDA. GUIDANCE. QUALITY CONTROL PRACTICES FOR COMPLIANCE WITH THE FEDERAL MERCURY VAPOR LAMP PERFORMANCE STANDARD. MAY 01, 1980.
US FDA. GUIDANCE. QUALITY SYSTEM INFORMATION FOR CERTAIN PREMARKET APPLICATION REVIEWS . FEB 03, 2003.
US FDA. GUIDANCE. QUALITY SYSTEMS APPROACH TO PHARMACEUTICAL CURRENT GOOD MANUFACTURING PRACTICE REGULATIONS. OCT 02, 2006.
US FDA. GUIDANCE. QUESTION-BASED REVIEW FOR THE CHEMISTRY, MANUFACTURING, AND CONTROLS TECHNICAL SECTION OF ANIMAL DRUG APPLICATIONS. #234. OCT 2016.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ABOUT EMDR - ELECTRONIC MEDICAL DEVICE REPORTING. FEB 14, 2014.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ABOUT THE FOOD ADDITIVE OR COLOR ADDITIVE PETITION PROCESS. APR 2011.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON BIOSIMILAR DEVELOPMENT AND THE BPCI ACT. REV. 2. SEP 2021.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON CURRENT GOOD MANUFACTURING PRACTICES - GENERAL PROVISIONS. APR 2009.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON CURRENT GOOD MANUFACTURING PRACTICES FOR DRUGS. MAR 2018.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON FDA’S FORTIFICATION POLICY. NOV 2015.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON HACCP REGULATION FOR FISH AND FISHERY PRODUCTS. JAN 01, 1999.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON INFORMED CONSENT ELEMENTS, 21 CFR 50.25(C). SMALL ENTITY COMPLIANCE GUIDE. FEB 2012.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON JUICE HACCP REGULATION (2003). SEP 03, 2003.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON JUICE HACCP REGULATION. AUG 31, 2001.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS ON QUALITY-RELATED CONTROLLED CORRESPONDENCE. SEP 2021.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING ADVERSE EVENT REPORTING AND RECORDKEEPING FOR DIETARY SUPPLEMENTS AS REQUIRED BY THE DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT. SEP 2013.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING CHANNELS OF TRADE POLICY FOR HUMAN FOOD COMMODITIES WITH CHLORPYRIFOS RESIDUES. FEB 2022.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING ESTABLISHMENT AND MAINTENANCE OF RECORDS BY PERSONS WHO MANUFACTURE, PROCESS, PACK, TRANSPORT, DISTRIBUTE, RECEIVE, HOLD, OR IMPORT FOOD (EDITION 5). FEB 2012.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING FOOD ALLERGENS, INCLUDING THE FOOD ALLERGEN LABELING REQUIREMENTS OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT (EDITION 5). NOV 2022.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING FOOD FACILITY REGISTRATION (SEVENTH EDITION). AUG 2018.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING MANDATORY FOOD RECALLS. NOV 2018.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING THE FINAL RULE, PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING PRODUCTION, STORAGE, AND TRANSPORTATION. JUL 2015.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING THE LABELING OF DIETARY SUPPLEMENTS AS REQUIRED BY THE DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT. SEP 2009.
US FDA. GUIDANCE. QUESTIONS AND ANSWERS REGARDING THE REPORTABLE FOOD REGISTRY AS ESTABLISHED BY THE FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007. SEP 2009.
US FDA. GUIDANCE. RADIATION BIODOSIMETRY MEDICAL COUNTERMEASURE DEVICE. APR 18, 2016.
US FDA. GUIDANCE. RADIATION SAFETY CONSIDERATIONS FOR X-RAY EQUIPMENT DESIGNED FOR HAND-HELD USE. DEC 24, 2008.
US FDA. GUIDANCE. RADIO FREQUENCY WIRELESS TECHNOLOGY IN MEDICAL DEVICES. AUG 14, 2013.
US FDA. GUIDANCE. REAL-TIME PREMARKET APPROVAL APPLICATION (PMA) SUPPLEMENTS. DEC 16, 2019.
US FDA. GUIDANCE. RECOGNITION AND USE OF A STANDARD FOR UNIFORM BLOOD AND BLOOD COMPONENT CONTAINER LABELS. JUN 2014.
US FDA. GUIDANCE. RECOGNITION AND WITHDRAWAL OF VOLUNTARY CONSENSUS STANDARDS. SEP 15, 2020.
US FDA. GUIDANCE. RECOGNITION OF ACCEPTABLE UNIQUE FACILITY IDENTIFER (UFI) FOR THE FOREIGN SUPPLIER VERIFICATION PROGRAMS REGULATION. MAR 2017.
US FDA. GUIDANCE. RECOMMENDATIONS FOR ASSESSMENT OF BLOOD DONOR ELIGIBILITY, DONOR DEFERRAL AND PRODUCT PRODUCT MANAGEMENT IN RESPONSE TO EBOLA VIRUS. JAN 2017.
US FDA. GUIDANCE. RECOMMENDATIONS FOR ASSESSMENT OF DONOR SUITABILITY AND BLOOD AND BLOOD PRODUCT SAFETY IN CASES OF POSSIBLE EXPOSURE TO ANTHRAX.. OCT 17, 2001.
US FDA. GUIDANCE. RECOMMENDATIONS FOR BLOOD ESTABLISHMENTS : TRAINING OF BACK-UP PERSONNEL, ASSESSMENT OF BLOOD DONOR SUITABILITY AND REPORTING CERTAIN CHANGES TO AN APPROVED APPLICATION. NOV 2010.
US FDA. GUIDANCE. RECOMMENDATIONS FOR CLINICAL LABORATORY IMPROVEMENT AMENDMENTS OF 1988 (CLIA) WAIVER APPLICATIONS FOR MANUFACTURERS OF IN VITRO DIAGNOSTIC DEVICES. FEB 26, 2020.
US FDA. GUIDANCE. RECOMMENDATIONS FOR COLLECTING RED BLOOD CELLS BY AUTOMATED APHERESIS METHODS - TECHNICAL CORRECTION FEBRUARY 2001.. FEB 13, 2001.
US FDA. GUIDANCE. RECOMMENDATIONS FOR DEFERRAL OF DONORS AND QUARANTINE AND RETRIEVAL OF BLOOD AND BLOOD PRODUCTS IN RECENT RECIPIENTS OF SMALLPOX VACCINE (VACCINIA VIRUS) AND CERTAIN CONTACTS OF SMALLPOX VACCINE RECIPIENTS. DEC 30, 2002.
US FDA. GUIDANCE. RECOMMENDATIONS FOR DONOR SCREENING WITH A LICENSED TEST FOR HIV-1 ANTIGEN: MEMORANDUM TO ALL REGISTERED BLOOD ESTABLISHMENTS. AUG 08, 1995.
US FDA. GUIDANCE. RECOMMENDATIONS FOR DUAL 510(K) AND CLIA WAIVER BY APPLICATION STUDIES. FEB 26, 2020.
US FDA. GUIDANCE. RECOMMENDATIONS FOR LABELING MEDICAL PRODUCTS TO INFORM USERS THAT THE PRODUCT OR PRODUCT CONTAINER IS NOT MADE WITH NATURAL RUBBER LATEX. DEC 2, 2014.
US FDA. GUIDANCE. RECOMMENDATIONS FOR MICROBIAL VECTORS USED FOR GENE THERAPY. SEP 2016.
US FDA. GUIDANCE. RECOMMENDATIONS FOR OBTAINING A LABELING CLAIM FOR COMMUNICABLE DISEASE DONOR SCREENING TESTS USING CADAVERIC BLOOD SPECIMENS FROM DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS):GUIDANCE FOR INDUSTRY. NOV 01, 2004.
US FDA. GUIDANCE. RECOMMENDATIONS FOR PREMARKET NOTIFICATION (510(K)) SUBMISSIONS FOR NUCLEIC ACID-BASED HUMAN LEUKOCYTE ANTIGEN (HLA) TEST KITS USED FOR MATCHING OF DONORS AND RECIPIENTS IN TRANSFUSION AND TRANSPLANTATION. JUL 2015.
US FDA. GUIDANCE. RECOMMENDATIONS FOR PREMARKET NOTIFICATIONS FOR LAMOTRIGINE AND ZONISAMIDE ASSAYS. FEB 9, 2016.
US FDA. GUIDANCE. RECOMMENDATIONS FOR PREPARATION AND SUBMISSION OF ANIMAL FOOD ADDITIVE PETITIONS. JUN 2015.
US FDA. GUIDANCE. RECOMMENDATIONS FOR REDUCING THE RISK OF TRANSFUSION-TRANSMITTED BABESIOSIS. MAY 2019.
US FDA. GUIDANCE. RECOMMENDATIONS FOR SCREENING, TESTING AND MANAGEMENT OF BLOOD DONORS AND BLOOD AND BLOOD COMPONENTS BASED ON SCREENING TESTS FOR SYPHILIS. DEC 2020.
US FDA. GUIDANCE. RECOMMENDATIONS FOR SPONSORS OF MEDICALLY IMPORTANT ANTIMICROBIAL DRUGS APPROVED FOR USE IN ANIMALS TO VOLUNTARILY BRING UNDER VETERINARY OVERSIGHT ALL PRODUCTS THAT CONTINUE TO BE AVAILABLE OVER-THE-COUNTER. #263. JUN 2021.
US FDA. GUIDANCE. RECOMMENDATIONS FOR SUBMISSION OF CHEMICAL AND TECHNOLOGICAL DATA FOR DIRECT FOOD ADDITIVE PETITIONS. MAR 2009.
US FDA. GUIDANCE. RECOMMENDATIONS FOR THE ASSESSMENT OF DONOR SUITABILITY AND BLOOD PRODUCT SAFETY IN CASES OF SUSPECTED SEVERE ACUTE RESPIRATORY SYNDROME (SARS) OR EXPOSURE TO SARS. APR 17, 2003.
US FDA. GUIDANCE. RECOMMENDATIONS FOR THE EARLY FOOD SAFETY EVALUATION OF NEW NON-PESTICIDAL PROTEINS PRODUCED BY NEW PLANT VARIETIES INTENDED FOR FOOD USE. JUN 19, 2006.
US FDA. GUIDANCE. RECOMMENDATIONS FOR THE MANAGEMENT OF DONOR AND UNITS THAT ARE INITIALLY REACTIVE FOR HEPATITIS B SURFACE ANTIGEN (HBSAG). DEC 02, 1987.
US FDA. GUIDANCE. RECOMMENDATIONS FOR THE QUARANTINE AND DISPOSITION OF UNITS FROM PRIOR COLLECTIONS FROM DONORS WITH REPEATEDLY REACTIVE SCREENING TESTS FOR HEPATITIS B VIRUS (HBV), HEPATITIS C VIRUS (HCV) AND HUMAN T-LYMPHOTROPIC VIRUS TYPE I (HTLV-I). JUL 19, 1996.
US FDA. GUIDANCE. RECOMMENDATIONS REGARDING LICENSE AMENDMENTS AND PROCEDURES FOR GAMMA IRRADIATION OF BLOOD PRODUCTS. JUL 22, 1993.
US FDA. GUIDANCE. RECOMMENDATIONS TO PROCESSORS OF APPLE JUICE OR CIDER ON THE USE OF OZONE FOR PATHOGEN REDUCTION PURPOSES. OCT 01, 2004.
US FDA. GUIDANCE. RECOMMENDATIONS TO REDUCE THE POSSIBLE RISK OF TRANSMISSION OF CREUTZFELDT-JAKOB DISEASE AND VARIANT CRETZFELDT-JAKOB DISEASE BY BLOOD AND BLOOD COMPONENTS. MAY 2022.
US FDA. GUIDANCE. RECOMMENDATIONS TO REDUCE THE RISK OF TRANSFUSION-TRANSMITTED MALARIA. DEC 2020.
US FDA. GUIDANCE. RECOMMENDED APPROACHES TO INTEGRATION OF GENETIC TOXICOLOGY STUDY RESULTS. JAN 04, 2006.
US FDA. GUIDANCE. RECOMMENDED CLINICAL STUDY DESIGN FOR VENTRICULAR TACHYCARDIA ABLATION. MAY 07, 1999.
US FDA. GUIDANCE. RECOMMENDED CONTENT AND FORMAT OF NON-CLINICAL BENCH PERFORMANCE TESTING INFORMATION IN PREMARKET SUBMISSIONS. DEC 20, 2019.
US FDA. GUIDANCE. RECOMMENDED STATEMENT FOR OVER-THE-COUNTER ASPIRIN-CONTAINING DRUG PRODUCTS LABELED WITH CARDIOVASCULAR RELATED IMAGERY. NOV 2017.
US FDA. GUIDANCE. RECOMMENDED STUDY DESIGN AND EVALUATION OF EFFECTIVENESS STUDIES FOR SWINE RESPIRATORY DISEASE CLAIMS. OCT 1, 2007.
US FDA. GUIDANCE. RECOMMENDED WARNING FOR OVER-THE-COUNTER ACETAMINOPHEN-CONTAINING DRUG PRODUCTS AND LABELING STATEMENTS REGARDING SERIOUS SKIN REACTIONS. JAN 2017.
US FDA. GUIDANCE. RECONDITIONING OF FISH AND FISHERY PRODUCTS BY SEGREGATION. APR 2022.
US FDA. GUIDANCE. RECRUITING STUDY SUBJECTS. JAN 01, 1998.
US FDA. GUIDANCE. RECURRENT HERPES LABIALIS : DEVELOPING DRUGS FOR TREATMENT AND PREVENTION. NOV 2017.
US FDA. GUIDANCE. REDBOOK 2000 : IV.C.5.A. CHRONIC TOXICITY STUDIES WITH RODENTS. JUL 2007.
US FDA. GUIDANCE. REDBOOK 2000 : IV. A. INTRODUCTION TO GUIDELINES FOR TOXICITY STUDIES. APR 2007.
US FDA. GUIDANCE. REDBOOK 2000 : IV.B. 1. GENERAL GUIDELINES FOR DESIGNING AND CONDUCTING TOXICITY STUDIES. APR 2007.
US FDA. GUIDANCE. REDBOOK 2000 : IV.C.1.A. BACTRERIAL REVERSE MUTATION TEST. JUL 2018.
US FDA. GUIDANCE. REDBOOK 2000 : IV.C.1.C MOUSE LYMPHOMA THYMIDINE KINASE GENE MUTATION ASSAY. NOV 2013.
US FDA. GUIDANCE. REDBOOK 2000 : IV.C.10. NEUROTOXICITY STUDIES. JUL 2007.
US FDA. GUIDANCE. REDBOOK 2000 : IV.C.6. CARCINOGENICITY STUDIES WITH RODENTS. JAN 2006.
US FDA. GUIDANCE. REDBOOK 2000 : IV.C.7. COMBINED CHRONIC TOXICITY / CARCINOGENICITY STUDIES WITH RODENTS. JUL 2007.
US FDA. GUIDANCE. REDBOOK 2000 : IV.C.9.A. GUIDELINES FOR REPRODUCTION STUDIES. JUL 2007.
US FDA. GUIDANCE. REDBOOK 2000 : VII GLOSSARY. ACRONYMS AND DEFINITIONS. APR 2007.
US FDA. GUIDANCE. REDBOOK 2000: IV.C.1.B. IN VITRO MAMMALIAN CHROMOSOMAL ABERRATION TEST. NOV 01, 2003.
US FDA. GUIDANCE. REDBOOK 2000: IV.C.1.D. MAMMALIAN ERYTHROCYTE MICRONUCLEUS TEST. JUL 01, 2000.
US FDA. GUIDANCE. REDBOOK 2000: IV.C.3.A. SHORT-TERM TOXICITY STUDIES WITH RODENTS. NOV 01, 2003.
US FDA. GUIDANCE. REDBOOK 2000: IV.C.3.B. SHORT-TERM TOXICITY STUDIES WITH NON-RODENTS. NOV 01, 2003.
US FDA. GUIDANCE. REDBOOK 2000: IV.C.4.A. SUBCHRONIC TOXICITY STUDIES WITH RODENTS. NOV 01, 2003.
US FDA. GUIDANCE. REDBOOK 2000: IV.C.4.B. SUBCHRONIC TOXICITY STUDIES WITH NON-RODENTS. NOV 01, 2003.
US FDA. GUIDANCE. REDBOOK 2000: IV.C.5.B. ONE-YEAR TOXICITY STUDIES WITH NON-RODENTS. NOV 01, 2003.
US FDA. GUIDANCE. REDBOOK 2000: IV.C.9.B. GUIDELINES FOR DEVELOPMENTAL TOXICITY STUDIES. JUL 01, 2000.
US FDA. GUIDANCE. REDBOOK 2000: VI.B EPIDEMIOLOGY. OCT 01, 2001.
US FDA. GUIDANCE. REDBOOK 2000. TOXICOLOGICAL PRINCIPLES FOR THE SAFETY ASSESSMENT OF FOOD INGREDIENTS. JUL 2007.
US FDA. GUIDANCE. REDUCING MICROBIAL FOOD SAFETY HAZARDS IN THE PRODUCTION OF SEED FOR SPROUTING. MAY 2022.
US FDA. GUIDANCE. REFERENCE AMOUNTS CUSTOMARILY CONSUMED : LIST OF PRODUCTS FOR EACH PRODUCT CATEGORY. FEB 2018.
US FDA. GUIDANCE. REFERENCE GUIDE FOR THE NONCLINICAL TOXICITY STUDIES OF ANTIVIRAL DRUGS INDICATED FOR THE TREATMENT OF N/A NON-LIFE THREATENING DISEASE EVALUATION OF DRUG TOXICITY PRIOR TO PHASE I CLINICAL STUDIES. MAR 02, 1998.
US FDA. GUIDANCE. REFERENCING APPROVED DRUG PRODUCTS IN ANDA SUBMISSIONS. OCT 2020.
US FDA. GUIDANCE. REFERENCING THE DEFINITION OF “DEVICE” IN THE FEDERAL FOOD, DRUG, AND COSMETIC ACT IN GUIDANCE, REGULATORY DOCUMENTS, COMMUNICATIONS, AND OTHER PUBLIC DOCUMENTS. NOV 14, 2022.
US FDA. GUIDANCE. REFERRAL PROGRAM FROM THE FOOD AND DRUG ADMINISTRATION TO THE NATIONAL OCEANIC AND ATMOSPHERIC ADMINISTRATION SEAFOOD INSPECTION PROGRAM FOR THE CERTIFICATION OF FISH AND FISHERY PRODUCTS FOR EXPERT TO THE EUROPEAN UNION AND THE EUROPEAN FREE TRADE ASSOCIATION. FEB 2009.
US FDA. GUIDANCE. REFRIGERATED CARROT JUICE AND OTHER REFRIGERATED LOW-ACID JUICES. JUN 2007.
US FDA. GUIDANCE. REFUSAL OF INSPECTION BY A FOREIGN FOOD ESTABLISHMENT OR FOREIGN GOVERNMENT. OCT 2022.
US FDA. GUIDANCE. REFUSAL OF INSPECTION OR ACCESS TO HACCP RECORDS PERTAINING TO THE SAFE AND SANITARY PROCESSING OF FISH AND FISHERY PRODUCTS. JUL 01, 2001.
US FDA. GUIDANCE. REFUSE TO ACCEPT POLICY FOR 510(K)S. APR 21, 2022.
US FDA. GUIDANCE. REGISTERING WITH CVM’S ELECTRONIC SUBMISSION SYSTEM. #108. JUL 2022.
US FDA. GUIDANCE. REGISTRATION AND PRODUCT LISTING FOR OWNERS AND OPERATORS OF DOMESTIC TOBACCO PRODUT ESTABLISHMENTS (REVISED). DEC 2017.
US FDA. GUIDANCE. REGISTRATION OF FOOD FACILITIES : WHAT YOU NEED TO KNOW ABOUT THE FDA REGULATION. MAY 2018.
US FDA. GUIDANCE. REGISTRATION OF HUMAN DRUG COMPOUNDING OUTSOURCING FACILITIES UNDER SECTION 503B OF THE FD&C ACT. NOV 2014.
US FDA. GUIDANCE. REGULATION OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS). SMALL ENTITY COMPLIANCE GUIDE. NOV 2022.
US FDA. GUIDANCE. REGULATORY CLASSIFICATION OF PHARMACEUTICAL CO-CRYSTALS. FEB 2018. REV. 1.
US FDA. GUIDANCE. REGULATORY CONSIDERATIONS FOR HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS ; MINIMAL MANIPULATION AND HOMOLOGOUS USE. JUL 2020.
US FDA. GUIDANCE. REGULATORY CONSIDERATIONS FOR MICRONEEDLING PRODUCTS. NOV 10, 2020.
US FDA. GUIDANCE. REGULATORY FRAMEWORK FOR SUBSTANCES INTENDED FOR USE IN HUMAN FOOD OR ANIMAL FOOD ON THE BASIS OF THE GENERALLY RECOGNIZED AS SAFE (GRAS) PROVISION OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. NOV 2017.
US FDA. GUIDANCE. REGULATORY REQUIREMENTS FOR HEARING AID DEVICES AND PERSONAL SOUND AMPLIFICATION PRODUCTS. AUG 17, 2022.
US FDA. GUIDANCE. RELEASE OF ORA LABORATORY ANALYTICAL RESULTS TO THE RESPONSIBLE PARTY. MAR 2019.
US FDA. GUIDANCE. REMOTE INTERACTIVE EVALUATIONS OF DRUG MANUFACTURING AND BIORESEARCH MONITORING FACILITIES DURING THE COVID-19 PULIC HEALTH EMERGENCY. APR 2021.
US FDA. GUIDANCE. REMOTE INTERLOCK CONNECTORS (LASER NOTICE 11). OCT 07, 1976.
US FDA. GUIDANCE. REMS : FDA’S APPLICATION OF STATUTORY FACTORS IN DETERMINING WHEN A REMS IS NECESSARY. APR 2019.
US FDA. GUIDANCE. RENAL CELL CARCINOMA : DEVELOPING DRUGS AND BIOLOGICS FOR ADJUVANT TREATMENT. JUN 2022.
US FDA. GUIDANCE. REPACKAGING OF CERTAIN HUMAN DRUG PRODUCTS BY PHARMACIES AND OUTSOURCING FACILITIES. JAN 2017.
US FDA. GUIDANCE. REPEAL OF SECTION 507 OF THE FEDERAL FOOD, DRUG AND COSMETIC ACT _1. JUN 15, 1998.
US FDA. GUIDANCE. REPLACEMENT REAGENT AND INSTRUMENT FAMILY POLICY FOR IN VITRO DIAGNOSTIC DEVICES. AUG 2022.
US FDA. GUIDANCE. REPORTING A TEMPORARY CLOSURE OR SIGNIFICANTLY REDUCED PRODUCTION BY A HUMAN FOOD ESTABLISHMENT AND REQUESTING FDA ASSISTANCE DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. MAY 2020.
US FDA. GUIDANCE. REPORTING AMOUNT OF LISTED DRUGS AND BIOLOGICAL PRODUCTS. TECHNICAL CONFORMANCE GUIDE. OCT 2021.
US FDA. GUIDANCE. REPORTING AND MITIGATING ANIMAL DRUG SHORTAGES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. #271. MAY 2020.
US FDA. GUIDANCE. REPORTING OF COMPUTATIONAL MODELING STUDIES IN MEDICAL DEVICE SUBMISSIONS. SEP 21 2106.
US FDA. GUIDANCE. REPORTS ON THE STATUS OF POSTMARKETING STUDY COMMITMENTS — IMPLEMENTATION OF SECTION 130 OF THE FOOD AND DRUG ADMINISTRATION MODERNIZATION ACT OF 1997. FEB 16, 2006.
US FDA. GUIDANCE. REPROCESSING MEDICAL DEVICES IN HEALTH CARE SETTINGS : CALIDATION METHODS AND LABELING. MAR 17, 2015.
US FDA. GUIDANCE. REPRODUCTIVE AND DEVELOPMENTAL TOXICITIES - INTEGRATING STUDY RESULTS TO ASSESS CONCERNS. SEP 2011.
US FDA. GUIDANCE. REQUALIFICATION METHOD FOR REENTRY OF BLOOD DONORS DEFERRED BECAUSE OF REACTIVE TEST RESULTS FOR ANTIBODY TO HEPATITS B CORE ANTIGEN (ANTI-HBC). MAY 2010.
US FDA. GUIDANCE. REQUALIFICATION METHOD FOR REENTRY OF DONORS WHO TEST HEPATITIS B SURFACE ANTIGEN (HBSAG) POSITIVE FOLLOWING A RECENT VACINATION AGAINST HEPATITIS B VIRUS INFECTION. NOV 2011.
US FDA. GUIDANCE. REQUALIFICATION OF DONORS PREVIOUSLY DEFERRED FOR A HISTORY OF VIRAL HEPATITIS AFTER THE 11TH BIRTHDAY. SEP 2017.
US FDA. GUIDANCE. REQUESTING FDA FEEDBACK ON COMBINATION PRODUCTS. DEC 2020.
US FDA. GUIDANCE. REQUESTS FOR FEEDBACK AND MEETINGS FOR MEDICAL DEVICE SUBMISSIONS : THE Q-SUBMISSION PROGRAM. JAN 6, 2021.
US FDA. GUIDANCE. REQUIRED WARNINGS FOR CIGARETTE PACKAGES AND ADVERTISEMENTS - SMALL ENTITY COMPLIANCE GUIDE. JUL 2021.
US FDA. GUIDANCE. REQUIREMENTS FOR THE SUBMISSION OF DATA NEEDED TO CALCULATE USER FEES FOR DOMESTIC MANUFACTURERS AND IMPORTERS OF TOBACCO PRODUCTS. SMALL ENTITY COMPLIANCE GUIDE. MAY 2016.
US FDA. GUIDANCE. REQUIREMENTS FOR TRANSACTIONS WITH FIRST RESPONDERS UNDER SECTION 582 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT - COMPLIANCE POLICY. FEB 2017. REV. 1.
US FDA. GUIDANCE. RESIDUAL DRUG IN TRANSDERMAL AND RELATED DRUG DELIVERY SYSTEMS. AUG 2011.
US FDA. GUIDANCE. RESIDUAL SOLVENTS IN ANIMAL DRUG PRODUCTS. QUESTIONS AND ANSWERS. #211. APR 2015.
US FDA. GUIDANCE. RESIDUAL SOLVENTS IN DRUG PRODUCTS MARKETED IN THE UNITED STATES. NOV 2009.
US FDA. GUIDANCE. RESPONSIBILITIES OF LASER LIGHT SHOW PROJECTOR MANUFACTURERS, DEALERS, AND DISTRIBUTORS (LASER NOTICE 51). MAY 26, 2001.
US FDA. GUIDANCE. RESUMING NORMAL DRUG AND BIOLOGICS MANUFACTURING OPERATIONS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. SEP 2020.
US FDA. GUIDANCE. RETURNING REFRIGERATED TRANSPORT VEHICLES AND REFRIGERATED STORAGE UNITS TO FOOD USES AFTER USING THEM TO PRESERVE HUMAN REMAINS DURING THE COVID-19 PANDEMIC. MAY 2020.
US FDA. GUIDANCE. REVIEW AND UPDATE OF DEVICE STABLISHMENT INSPECTION PROCESSES AND STANDARDS. JUN 29, 2020.
US FDA. GUIDANCE. REVIEW CRITERIA FOR ASSESSMENT OF C-REACTIVE PROTEIN (CRP), HIGH SENSITIVITY C-REACTIVE PROTEIN (HSCRP) AND CARDIAC C-REACTIVE ASSAYS. SEP 22, 2005.
US FDA. GUIDANCE. REVIEW CRITERIA FOR PREMARKET APPROVAL OF IN VITRO DIAGNOSTIC DEVICES FOR DETECTION OF ANTIBODIES TO PARVOVIRUS B19. MAY 15, 1992.
US FDA. GUIDANCE. REVIEW GUIDELINES FOR OXYGEN GENERATORS AND OXYGEN EQUIPMENT FOR EMERGENCY USE. JAN 01, 1977.
US FDA. GUIDANCE. REVIEW OF FDA'S IMPLEMENTATION OF THE DRUG EXPORT AMENDMENTS OF 1986. NOV 01, 1989.
US FDA. GUIDANCE. REVIEW TIMELINES FOR APPLICANT RESPONSES TO COMPLETE RESPONSE LETTERS WHEN A FACILITY ASSESSMENT IS NEEDED DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. DEC 2020.
US FDA. GUIDANCE. REVIEWER GUIDANCE FOR NEBULIZERS, METERED DOSE INHALERS, SPACERS AND ACTUATORS. SEP 30, 1993.
US FDA. GUIDANCE. REVIEWER GUIDANCE, VALIDATION OF CHROMATOGRAPHIC METHODS. NOV 01, 1994.
US FDA. GUIDANCE. REVIEWERS GUIDANCE CHECKLIST FOR ORTHOPEDIC EXTERNAL FIXATION DEVICES VERSION #5. FEB 20, 1997.
US FDA. GUIDANCE. REVISED PROCEDURES FOR ADDING LENS FINISHING LABORATORIES TO APPROVED PREMARKET APPROVAL APPLICATIONS FOR CLASS III RIGID GAS PERMEABLE CONTACT LENSES FOR EXTENDED WEAR . AUG 10, 1998.
US FDA. GUIDANCE. REVISED RECOMMENDATIONS FOR DETERMINING ELIGIBILITY OF DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS WHO HAVE RECEIVED HUMAN-DERIVED CLOTTING FACTOR CONCENTRATES. NOV 2016.
US FDA. GUIDANCE. REVISED RECOMMENDATIONS FOR RED BLOOD CELL IMMUNIZATION PROGRAMS FOR SOURCE PLASMA DONORS: MEMORANDUM TO LICENSED ESTABLISHMENTS. MAR 14, 1995.
US FDA. GUIDANCE. REVISED RECOMMENDATIONS FOR REDUCING THE RISK OF HUMAN IMMUNODEFICIENCY VIRUS TRANSMISSION BY BLOOD AND BLOOD PRODUCTS. AUG 2020.
US FDA. GUIDANCE. REVISED RECOMMENDATIONS FOR TESTING WHOLE BLOOD, BLOOD COMPONENTS, SOURCE PLASMA AND SOURCE LEUKOCYTES FOR ANTIBODY TO HEPATITIS C VIRUS ENCODED ANTIGEN (ANTI-HCV). APR 23, 1992.
US FDA. GUIDANCE. REVISED RECOMMENDATIONS FOR TESTING WHOLE BLOOD, BLOOD COMPONENTS, SOURCE PLASMA AND SOURCE LEUKOCYTES FOR ANTIBODY TO HEPATITIS C VIRUS ENCODED ANTIGEN (ANTI-HCV). AUG 05, 1993.
US FDA. GUIDANCE. REVISED RECOMMENDATIONS REGARDING INVALIDATION OF TEST RESULTS OF LICENSED AND 510(K) CLEARED BLOODBORNE PATHOGEN ASSAYS USED TO TEST DONORS. JUL 11, 2001.
US FDA. GUIDANCE. REVISING ANDA LABELING FOLLOWING REVISION OF THE RLD LABELING. APR 26, 2000.
US FDA. GUIDANCE. RISK EVALUATION AND MITIGATION STRATEGIES : MODIFICATIONS AND REVISIONS. JUN 2020. REV. 2.
US FDA. GUIDANCE. ROLE OF HIV RESISTANCE TESTING IN ANTIRETROVIRAL DRUG DEVELOPMENT. OCT 2007.
US FDA. GUIDANCE. S10 PHOTOSAFETY EVALUATION OF PHARMACEUTICALS. JAN 2015.
US FDA. GUIDANCE. S11 NONCLINICAL SAFETY TESTING IN SUPPORT OF DEVELOPMENT OF PEDIATRIC PHARMACEUTICALS. MAY 2021.
US FDA. GUIDANCE. S1A THE NEED FOR LONG-TERM RODENT CARCINOGENICITY STUDIES OF PHARMACEUTICALS. MAR 01, 1996.
US FDA. GUIDANCE. S1B TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS. FEB 23, 1998.
US FDA. GUIDANCE. S1B(R1) ADDENDUM TO S1B TESTING FOR CARCINOGENICITY OF PHARMACEUTICALS. NOV 2022.
US FDA. GUIDANCE. S1C(R2) DOSE SELECTION FOR CARCINOGENICITY STUDIES. SEP 2008. REV. 1.
US FDA. GUIDANCE. S2(R1) GENOTOXICITY TESTING AND DATA INTERPREATION FOR PHARMACEUTICALS INTENDED FOR HUMAN USE. JUN 2012.
US FDA. GUIDANCE. S2A SPECIFIC ASPECTS OF REGULATORY GENOTOXICITY TESTS FOR PHARMACEUTICALS. APR 24, 1996.
US FDA. GUIDANCE. S2B GENOTOXICITY: A STANDARD BATTERY FOR GENOTOXICITY TESTING OF PHARMACEUTICALS. NOV 21, 1997.
US FDA. GUIDANCE. S3A GUIDANCE. NOTE FOR GUIDANCE ON TOXICOKINETICS. THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES : FOCUS ON MICROSAMPLING. QUESTIONS AND ANSWERS. MAY 2018.
US FDA. GUIDANCE. S3A TOXICOKINETICS: THE ASSESSMENT OF SYSTEMIC EXPOSURE IN TOXICITY STUDIES. MAR 01, 1995.
US FDA. GUIDANCE. S3B PHARMACOKINETICS: GUIDANCE FOR REPEATED DOSE TISSUE DISTRIBUTION STUDIES. MAR 01, 1995.
US FDA. GUIDANCE. S4A DURATION OF CHRONIC TOXICITY TESTING IN ANIMALS (RODENT AND NONRODENT TOXICITY TESTING). JUN 25, 1999.
US FDA. GUIDANCE. S6 ADDENDUM TO PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS. MAY 2012.
US FDA. GUIDANCE. S6 PRECLINICAL SAFETY EVALUATION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS. NOV 18, 1997.
US FDA. GUIDANCE. S6(R1) PRECLINICAL SAFETY EVALUTION OF BIOTECHNOLOGY-DERIVED PHARMACEUTICALS. MAY 2012.
US FDA. GUIDANCE. S7A SAFETY PHARMACOLOGY STUDIES FOR HUMAN PHARMACEUTICALS. JUL 13, 2001.
US FDA. GUIDANCE. S7B NONCLINICAL EVALUATION OF THE POTENTIAL FOR DELAYED VENTRICULAR REPOLARIZATION (QT INTERVAL PROLONGATION) BY HUMAN PHARMACEUTICALS. OCT 20, 2005.
US FDA. GUIDANCE. S8 IMMUNOTOXICITY STUDIES FOR HUMAN PHARMACEUTICALS. APR 12, 2006.
US FDA. GUIDANCE. S9 NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS. MAR 2010.
US FDA. GUIDANCE. S9 NONCLINICAL EVALUATION FOR ANTICANCER PHARMACEUTICALS. QUESTIONS AND ANSWERS. JUN 2018.
US FDA. GUIDANCE. SAFER TECHNOLOGIES PROGRAM FOR MEDICAL DEVICES. JAN 6, 2021.
US FDA. GUIDANCE. SAFETY AND PERFORMANCE BASED PATHWAY. SEP 20, 2019.
US FDA. GUIDANCE. SAFETY CONSIDERATIONS FOR CONTAINER LABELS AND CARTON LABELING DESIGN TO MINIMIZE MEDICATION ERRORS. MAY 2022.
US FDA. GUIDANCE. SAFETY CONSIDERATIONS FOR PRODUCT DESIGN TO MINIMIZE MEDICATION ERRORS. APR 2016.
US FDA. GUIDANCE. SAFETY CONSIDERATIONS TO MITIGATE THE RISKS OF MISCONNECTIONS WITH SMALL-BORE CONNECTORS INTENDED FOR ENTERAL APPLICATIONS. FEB 11, 2015.
US FDA. GUIDANCE. SAFETY LABELING CHANGES - IMPLEMENTATION OF SECTION 505(O)(4) OF THE FD&C ACT. JUL 2013.
US FDA. GUIDANCE. SAFETY OF IMPORTED TRADITIONAL POTTERY INTENDED FOR USE WITH FOOD AND THE USE OF THE TERM “LEAD FREE” IN THE LABELING OF POTTERY / PROPER IDENTIFICATION OF ORNAMENTAL AND DECORATIVE CERAMICWARE. NOV 2010.
US FDA. GUIDANCE. SAFETY OF NANOMATERIALS IN COSMETIC PRODUCTS. JUN 2014.
US FDA. GUIDANCE. SAFETY REPORTING REQUIREMENTS FOR INDS AND BA/BE STUDIES - SMALL ENTITY COMPLIANCE GUIDE. DEC 2012.
US FDA. GUIDANCE. SAFETY REPORTING REQUIREMENTS FOR INDS AND BA/BE STUDIES. DEC 2012.
US FDA. GUIDANCE. SAFETY, EFFICACY, AND PHARMACOKINETIC STUDIES TO SUPPORT MARKETING OF IMMUNE GLOBULIN INTRAVENOUS (HUMAN) AS REPLACEMENT THERAPY FOR PRIMARY HUMORAL IMMUNODEFICIENCY. JUN 2008.
US FDA. GUIDANCE. SALINE, SILICONE GEL, AND ALTERNATIVE BREAST IMPLANTS. SEP 29, 2020.
US FDA. GUIDANCE. SAME SURGICAL PROCEDURE EXCEPTION UNDER 21 CFR 1271.15(B) : QUESTIONS AND ANSWERS REGARDING THE SCOPE OF THE EXCEPTION. NOV 2017.
US FDA. GUIDANCE. SANITARY TRANSPORTATION OF FOOD. APR 2010.
US FDA. GUIDANCE. SANITARY TRANSPORTATION OF HUMAN AND ANIMAL FOOD : WHAT YOU NEED TO KNOW ABOUT THE FDA. REGULATION : SMALL ENTITY COMPLIANCE GUIDE. NOV 2017.
US FDA. GUIDANCE. SCIENTIFIC CONSIDERATIONS IN DEMONSTRATING BIOSIMILARITY TO A REFERENCE PRODUCT. APR 2015.
US FDA. GUIDANCE. SCIENTIFIC EVALUATION OF THE EVIDENCE ON THE BENEFICIAL PHYSIOLOGICAL EFFECTS OF ISOLATED OR SYNTHETIC NON-DIGESTIBLE CARBOHYDRATES SUBMITTED AS A CITIZEN PETITION (21 CFR 10.30). FEB 2018.
US FDA. GUIDANCE. SCREENING TESTS PRIOR TO STUDY ENROLLMENT. JAN 01, 1998.
US FDA. GUIDANCE. SEAFOOD HACCP AND THE FDA FOOD SAFETY MODERNIZATION ACT. DEC 2021.
US FDA. GUIDANCE. SEAFOOD HACCP TRANSITION GUIDANCE. DEC 01, 1999.
US FDA. GUIDANCE. SEC. 100.250 FOOD FACILITY REGISTRATION - HUMAN AND ANIMAL FOOD. COMPLIANCE POLICY GUIDE. JUN 2014.
US FDA. GUIDANCE. SEC. 335.700 SURGEONS’ GLOVES AND PATIENT EXAMINATION GLOVES; DEFECTS - CRITERIA FOR DIRECT REFERENCE SEIZURE. MAR 2011.
US FDA. GUIDANCE. SEC. 390.200 DETERMINATION BY SECRETARY THAT PRODUCT FAILS TO COMPLY OR HAS DEFECT - 21 CFR 1003.11. COMPLIANCE POLICY GUIDE. NOV 2012.
US FDA. GUIDANCE. SEC. 420.500 INTERFERENCE WITH COMPENDIAL TESTS. COMPLIANCE POLICY GUIDE. NOV 2012.
US FDA. GUIDANCE. SEC. 527.300 DAIRY PRODUCTS - MICROBIAL CONTAMINANTS AND ALKALINE PHOSPHATASE ACTIVITY (CPG 7106.08). COMPLIANCE POLICY GUIDE. DEC 2009.
US FDA. GUIDANCE. SEC. 540.525 SCROMBROTOXIN (HISTAMINE)-FORMING FISH AND FISHERY PRODUCTS - DECOMPOSITION AND HISTAMINE (CPG 7108.24). DRAFT COMPLIANCE POLICY GUIDE. DEC 2021.
US FDA. GUIDANCE. SEC. 608.200 PRESCRIPTION USE OF CERTAIN INJECTABLE ANIMAL DRUGS. COMPLIANCE POLICY GUIDE. MAR 2019.
US FDA. GUIDANCE. SEC. 615.115 EXTRALABEL USE OF MEDICATED FEEDS FOR MINOR SPECIES. COMPLIANCE POLICY GUIDE. DEC 2016.
US FDA. GUIDANCE. SEC. 635.100 LARGE VOLUME PARENTERALS (LVPS) FOR ANIMAL USE. COMPLIANCE POLICY GUIDE. MAR 2019.
US FDA. GUIDANCE. SEC. 651.100 ETHYLENEDIAMINE DIHYDROIODIDE (EDDI). COMPLIANCE POLICY GUIDE. JUN 2019.
US FDA. GUIDANCE. SEC. 653.100 ANIMAL GROOMING AIDS. COMPLIANCE POLICY GUIDE. MAR 2019.
US FDA. GUIDANCE. SEC. 665.300 USE OF TYPE A MEDICATED ARTICLE PROPRIETARY NAMES IN THE NAMES OF MEDICATED FEEDS. MAR 2019.
US FDA. GUIDANCE. SEC. 666.100 ALTERNATE FEEDING OF DIFFERENT MEDICATED FEEDS. COMPLIANCE POLICY GUIDE. MAR 2019.
US FDA. GUIDANCE. SEC. 683.100 ACTIVE LEVELS FOR AFLATOXINS IN ANIMAL FOOD. COMPLIANCE POLICY GUIDE. MAR 2019.
US FDA. GUIDANCE. SEC. 690.800 SALMONELLA IN FOOD FOR ANIMALS. COMPLIANCE POLICY GUIDE. JUL 2013.
US FDA. GUIDANCE. SECTION 503A BULKS LIST. FINAL RULE. QUESTIONS AND ANSWERS. SMALL ENTITY COMPLIANCE GUIDE. MAY 2019.
US FDA. GUIDANCE. SECTION 905(J) REPORTS : DEMONTRATING SUBSTANTIAL EQUIVALENCE FOR TOBACCO PRODUCTS. JAN 5, 2011.
US FDA. GUIDANCE. SELECT UPDATES FOR NON-CLINICAL ENGINEERING TESTS AND RECOMMENDED LABELING FOR INTRAVASCULAR STENTS AND ASSOCIATED DELIVERY SYSTEMS. AUG 18, 2015.
US FDA. GUIDANCE. SELECTION OF THE APPROPRIATE PACKAGE TYPE TERMS AND RECOMMENDATIONS FOR LABELING INJECTABLE MEDICAL PRODUCTS PACKAGED IN MULTIPLE-DOSE, SINGLE-DOSE AND SINGLE-PATIENT-USE CONTAINERS FOR HUMAN USE. OCT 2018.
US FDA. GUIDANCE. SELF-IDENTIFICATION OF GENERIC DRUG FACILITIES, SITES, AND ORGANIZATIONS. SEP 2016.
US FDA. GUIDANCE. SELF-MONITORING BLOOD GLUCOSE TEST SYSTEMS FOR OVER-THE-COUNTER USE. SEP 29, 2020.
US FDA. GUIDANCE. SELF-SELECTION STUDIES FOR NONPRESCRIPTION DRUG PRODUCTS. APR 2013.
US FDA. GUIDANCE. SEVENTH OF A SERIES OF LETTERS ABOUT THE ACT PROVIDING GUIDANCE ON THE "130-DAY EXCLUSIVITY" PROVISION OF SECTION 505(J)(4)(B)(IV) OF THE FD&C. JUL 29, 1988.
US FDA. GUIDANCE. SEVERELY DEBILITATING OR LIFE-THREATENING HEMATOLOGIC DISORDERS : NONCLINICAL DEVELOPMENT OF PHARMACEUTICALS. MAR 2019.
US FDA. GUIDANCE. SHELF LIFE OF MEDICAL DEVICES. APR 01, 1991.
US FDA. GUIDANCE. SINGLE DOSE ACUTE TOXICITY TESTING FOR PHARMACEUTICALS. AUG 26, 1996.
US FDA. GUIDANCE. SIZE OF BEADS IN DRUG PRODUCTS LABELED FOR SPRINKLE. MAY 2012. REV. 1.
US FDA. GUIDANCE. SIZE, SHAPE, AND OTHER PHYSICAL ATTRIBUTES OF GENERIC TABLETS AND CAPSULES. OCT 2022. REV. 1.
US FDA. GUIDANCE. SLIT LAMP GUIDANCE. JUL 07, 1998.
US FDA. GUIDANCE. SLOWLY PROGRESSIVE, LOW-PREVALENCE RARE DISEASES WITH SUBSTRATE DEPOSITION THAT RESULT FROM SINGLE ENZYME DEFECTS : PROVIDING EVIDENCE OF EFFECTIVENESS FOR REPLACEMENT OR CORRECTIVE THERAPIES. MAR 2020.
US FDA. GUIDANCE. SMALL BUSINESS NUTRITION LABELING EXEMPTION. MAY 2007.
US FDA. GUIDANCE. SMALL ENTITIES COMPLIANCE GUIDE FOR FEEDERS OF RUMINANT ANIMALS WITHOUT ON-FARM FEED MIXING OPERATIONS. JUL 13, 2009.
US FDA. GUIDANCE. SMALL ENTITY COMPLIANCE GUIDE ON STRUCTURE/FUNCTION CLAIMS. JAN 09, 2002.
US FDA. GUIDANCE. SMALL ENTITY COMPLIANCE GUIDE: JUICE HACCP. APR 04, 2003.
US FDA. GUIDANCE. SMALL ENTITY COMPLIANCE GUIDE: LABEL WARNING STATEMENTS FOR IRON-CONTAINING SUPPLEMENTS AND DRUGS. OCT 17, 2003.
US FDA. GUIDANCE. SMALL ENTITY COMPLIANCE GUIDE: SAFE HANDLING STATEMENTS ON LABELING OF SHELL EGGS AND THE REFRIGERATION OF SHELL EGGS HELD FOR RETAIL DISTRIBUTION. JUL 01, 2001.
US FDA. GUIDANCE. SMALL ENTITY COMPLIANCE GUIDE: SERVING SIZES REFERENCE AMOUNT FOR BAKING POWDER, BAKING SODA, AND PECTIN. JUL 01, 2001.
US FDA. GUIDANCE. SMALL ENTITY COMPLIANCE GUIDE: STATEMENT OF IDENTITY, NUTRITION LABELING AND INGREDIENT LABELING OF DIETARY SUPPLEMENTS. JAN 03, 1999.
US FDA. GUIDANCE. SMALL ENTITY COMPLIANCE GUIDE: TRANS FATTY ACIDS IN NUTRITION LABELING, NUTRIENT CONTENT CLAIMS, AND HEALTH CLAIMS. AUG 20, 2003.
US FDA. GUIDANCE. SMALL ENTITY COMPLIANCE GUIDE. FOOD LABELING : REVISION OF THE NUTRITION AND SUPPLEMENT FACTS LABELS. JAN 2020.
US FDA. GUIDANCE. SOFTWARE AS A MEDICAL DEVICE (SAMD) : CLINICAL EVALUATION. DEC 8, 2017.
US FDA. GUIDANCE. SOURCE ANIMAL, PRODUCT, PRECLINICAL, AND CLINICAL ISSUES CONCERNING THE USE OF XENOTRANSPLANTATION PRODUCTS IN HUMANS. DEC 2016.
US FDA. GUIDANCE. SPECIAL PROTOCOL ASSESSMENT. APR 2018.
US FDA. GUIDANCE. SPECIFICATION OF THE UNIQUE FACILITY IDENTIFER (UFI) SYSTEM FOR DRUG ESTABLISHMENT REGISTRATION. NOV 2014.
US FDA. GUIDANCE. SPECIFICATIONS FOR PREPARING AND SUBMITTING ELECTRONIC ICSRS AND ICSR ATTACHMENTS. APR 2021.
US FDA. GUIDANCE. SPINAL PLATING SYSTEMS - PERFORMANCE CRITERIA FOR SAFETY AND PERFORMANCE BASED PATHWAY. DEC 11, 2020.
US FDA. GUIDANCE. SPINAL SYSTEM 510(K)S. MAY 02, 2004.
US FDA. GUIDANCE. SPONSOR - INVESTIGATOR - IRB INTERRELATIONSHIP. JAN 01, 1998.
US FDA. GUIDANCE. STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AN DMEDICINAL PRODUCTS IN CLIMATIC ZONES III AND IV. VICH GL58. #259. APR 2020.
US FDA. GUIDANCE. STABILITY TESTING OF NEW VETERINARY DRUG SUBSTANCES AND MEDICINAL PRODUCTS (REVISION). VICH GL3(R). #73. NOV 21, 2007.
US FDA. GUIDANCE. STANDARDIZED TRAINING CURRICULUM FOR APPLICATION OF HACCP PRINCIPLES TO JUICE PROCESSING. JUN 13, 2003.
US FDA. GUIDANCE. STANDARDS DEVELOPMENT AND THE USE OF STANDARDS IN REGULATORY SUBMISSIONS REVIEWED IN THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH. MAR 2019.
US FDA. GUIDANCE. STANDARDS FOR SECURING THE DRUG SUPPLY CHAIN - STANDARDIZED NUMERICAL IDENTIFICATION FOR PRESCRIPTION DRUG PACKAGES. MAR 2010.
US FDA. GUIDANCE. STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION : WHAT YOU NEED TO KNOW ABOUT HTE FDA REGULATION. SMALL ENTITY COMPLIANCE GUIDE. SEP 2017.
US FDA. GUIDANCE. STANDARDS FOR THE PROMPT REVIEW OF EFFICACY SUPPLEMENTS, INCLUDING PRIORITY EFFICACY SUPPLEMENTS . MAY 01, 1998.
US FDA. GUIDANCE. STATEMENT OF POLICY - FOODS DERIVED FROM NEW PLANT VARIETIES. MAY 29, 1992.
US FDA. GUIDANCE. STATISTICAL APPROACHES TO ESTABLISHING BIOEQUIVALENCE. FEB 01, 2001.
US FDA. GUIDANCE. STATISTICAL CONSIDERATIONS FOR CLINICAL TRIALS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. JUN 2020.
US FDA. GUIDANCE. STATISTICAL EVALUATION OF STABILITY DATA. VICH GL51. #219. MAY 2014.
US FDA. GUIDANCE. STATISTICAL GUIDANCE ON REPORTING RESULTS FROM STUDIES EVALUATING DIAGNOSTIC TESTS. MAR 13, 2007.
US FDA. GUIDANCE. STERILE DRUG PRODUCTS PRODUCED BY ASEPTIC PROCESSING — CURRENT GOOD MANUFACTURING PRACTICE. OCT 04, 2004.
US FDA. GUIDANCE. STERILITY REQUIREMENT FOR AQUEOUS-BASED DRUG PRODUCTS FOR ORAL INHALATION — SMALL ENTITY COMPLIANCE GUIDE. NOV 07, 2001.
US FDA. GUIDANCE. STERILIZED CONVENIENCE KITS FOR CLINICAL AND SURGICAL USE. JAN 07, 2002.
US FDA. GUIDANCE. STREAMLINING THE DONOR INTERVIEW PROCESS: RECOMMENDATIONS FOR SELF-ADMINISTERED QUESTIONNAIRES. JUL 03, 2003.
US FDA. GUIDANCE. STREET DRUG ALTERNATIVES. APR 03, 2000.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING ANIMALS : COMPARATIVE METABOLISM STUDIES IN LABORATORY ANIMALS. VICH GL47. #206. SEP 15, 2011.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING ANIMALS : MARKER RESIDUE DEPLETION STUDIES TO ESTABLISH PRODUCT WITHDRAWAL PERIODS. VICH GL48(R). #207. MAR 2015.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING ANIMALS : METABOLISM STUDY TO DETERMINE THE QUANTITY AND IDENTIFY THE NATURE OF RESIDUES (MRK). VICH GL46. #205. SEP 15, 2011.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING ANIMALS : VALIDATION OF ANALYTICAL METHODS USED IN RESIDUE DEPLETION STUDIES. VICH GL49(R). #208.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING SPECIES : MARKER RESIDUE DEPLETION STUDIES TO ESTABLISH PRODUCT WITHDRAWAL PERIODS IN AQUATIC SPECIES. VICH GL57. #257. AUG 2019.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE METABOLISM AND RESIDUE KINETICS OF VETERINARY DRUGS IN FOOD-PRODUCING SPECIES : STUDY DESIGN RECOMMENDATIONS FOR RESIDUE STUDIES IN HONEY FOR ESTABLISHING MRLS AND WITHDREAWAL PERIODS. VICH GL56. NOV 2018.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD : GENERAL APPROACH TO ESTABLISH A MICROBIOLOGICAL ADI. VICH GL36(R). #159. JAN 2022.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD : GENERAL APPROACH TO ESTABLISH AN ACUTE REFERENCE DOSE (ARFD). VICH GL54. #232. AUG 2017.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD : GENERAL APPROACH TO TESTING. VICH GL33. #149. MAR 17, 2009.
US FDA. GUIDANCE. STUDIES TO EVALUATE THE SAFETY OF RESIDUES OF VETERINARY DRUGS IN HUMAN FOOD : GENOTOXICITY TESTING. VICH GL23(R). #116. MAY 2015.
US FDA. GUIDANCE. STUDY AND EVALUATION OF GENDER DIFFERENCES IN THE CLINICAL EVALUATION OF DRUGS. JUL 22, 1993.
US FDA. GUIDANCE. STUDY OF DRUGS LIKELY TO BE USED IN THE ELDERLY. NOV 01, 1989.
US FDA. GUIDANCE. STUDYING MULTIPLE VERSIONS OF A CELLULAR OR GENE THERAPY PRODUCT IN AN EARLY-PHASE CLINICAL TRIAL. NOV 2022.
US FDA. GUIDANCE. SUBMISSION AND RESOLUTION OF FORMAL DISPUTES REGARDING THE TIMELINESS OF PREMARKET REVIEW OF A COMBINATION PRODUCT. MAY 03, 2004.
US FDA. GUIDANCE. SUBMISSION AND REVIEW OF STERILITY INFORMATION IN PREMARKET NOTIFICATION (510()) SUBMISSIONS FOR DEVICES LABELED AS STERILE. JAN 21, 2016.
US FDA. GUIDANCE. SUBMISSION DOCUMENTATION FOR STERILIZATION PROCESS VALIDATION IN APPLICATIONS FOR HUMAN AND VETERINARY DRUG PRODUCTS. NOV 01, 1994.
US FDA. GUIDANCE. SUBMISSION OF ABBREVIATED REPORTS AND SYNOPSES IN SUPPORT OF MARKETING APPLICATIONS.. SEP 13, 1999.
US FDA. GUIDANCE. SUBMISSION OF DOCUMENTATION IN APPLICATIONS FOR PARAMETRIC RELEASE O FHUMAN AND VETERINARY DRUG PRODUCTS TERMINALLY STERILIZED BY MOIST HEAT PROCESSES. FEB 2010.
US FDA. GUIDANCE. SUBMISSION OF PLANS FOR CIGARETTE PACKAGES AND CIGARETTE ADVERTISEMENTS (REVISED). JUL 2021.
US FDA. GUIDANCE. SUBMISSION OF PREMARKET NOTIFICATIONS FOR MAGNETIC RESONANCE DIAGNOSTIC DEVICES. NOV 18, 2016.
US FDA. GUIDANCE. SUBMISSION OF SUMMARY BIOEQUIVALENCE DATA FOR ANDAS. MAY 2011.
US FDA. GUIDANCE. SUBMISSION OF WARNING PLANS FOR CIGARS (REVISED). AUG 2018.
US FDA. GUIDANCE. SUBMISSIONS FOR POSTAPPROVAL MODIFICATIONS TO A COMBINATION PRODUCT APPROVED UNDER A BLA, NDA, OR PMA. JAN 2013.
US FDA. GUIDANCE. SUBMITTING A REPORT FOR MULTIPLE FACILITIES TO THE REPORTABLE FOOD ELECTRONIC PORTAL AS ESTABLISHED BY THE FOOD AND DRUG ADMINISTRATION AMENDMENTS ACT OF 2007. MAR 2010.
US FDA. GUIDANCE. SUBMITTING AND REVIEWING COMPLETE RESPONSES TO CLINICAL HOLDS (REVISED). OCT 01, 2000.
US FDA. GUIDANCE. SUBMITTING DOCUMENTS USING REAL-WORLD DATA AND REAL-WORLD EVIDENCE TO FDA FOR DRUGS AND BIOLOGICS. SEP 2022.
US FDA. GUIDANCE. SUBMITTING FORM FDA 2541 (FOOD CANNING ESTABLISHMENT REGISTRATION) AND FORMS FDA 2541D, FDA 2541E, FDA2541F, AND FDA 2541G (FOOD PROCESS FILING FORMS) TO FDA IN ELECTRONIC OR PAPER FORMAT. NOV 2016.
US FDA. GUIDANCE. SUBMITTING NEXT GENERATION SEQUENCING DATA TO THE DIVISION OF ANTIVIRAL PRODUCTS. JUL 2019.
US FDA. GUIDANCE. SUBMITTING REQUESTS UNDER 21 CFR 170.39 THRESHOLD OF REGULATION FOR SUBSTANCES USED IN FOOD-CONTACT ARTICLES. APR 01, 2005.
US FDA. GUIDANCE. SUBMITTING SEPARATE MARKETING APPLICATIONS AND CLINICAL DATA FOR PURPOSES OF ASSESSING USER FEES. JAN 03, 2005.|
US FDA. GUIDANCE. SUBMITTING STUDY DATASETS FOR VACCINES TO THE OFFICE OF VACCINES RESEARCH AND REVIEW. TECHNICAL SPECIFICS DOCUMENT. DEC 2019.
US FDA. GUIDANCE. SUBSTANTIATION FOR DIETARY SUPPLEMENT CLAIMS MADE UNDER SECTION 403(R)(6) OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. JAN 2009.
US FDA. GUIDANCE. SUGGESTED FORMAT FOR IDE PROGRESS REPORT. MAY 31, 1996.
US FDA. GUIDANCE. SUMMARY FOR NEW DRUG AND ANTIBIOTIC APPLICATIONS-FORMAT AND CONTENT OF THE SUMMARY FOR NEW DRUG AND ANTIBIOTIC APPLICATIONS. FEB 01, 1987.
US FDA. GUIDANCE. SUMMARY TABLE OF RECOMMENDED TOXICOLOGICAL TESTING FOR ADDITIVES USED IN FOOD. JUN 01, 2006.
US FDA. GUIDANCE. SUNSCREEN INNOVATION ACT : SECTION 586C(C) ADVISORY COMMITTEE PROCESS. OCT 2016.
US FDA. GUIDANCE. SUNSCREEN INNOVATION ACT : WITHDRAWAL OF A 586A REQUEST OR PENDING REQUEST. OCT 2016.
US FDA. GUIDANCE. SUPAC : MANUFACTURING EQUIPMENT ADDENDUM. DEC 2014.
US FDA. GUIDANCE. SUPAC-IR QUESTIONS AND ANSWERS ABOUT SUPAC-IR GUIDANCE. FEB 18, 1997.
US FDA. GUIDANCE. SUPAC-IR: IMMEDIATE-RELEASE SOLID ORAL DOSAGE FORMS: SCALE-UP AND POST-APPROVAL CHANGES: CHEMISTRY, MANUFACTURING AND CONTROLS, IN VITRO DISSOLUTION TESTING, AND IN VIVO BIOEQUIVALENCE DOCUMENTATION. NOV 01, 1995.
US FDA. GUIDANCE. SUPAC-MR: MODIFIED RELEASE SOLID ORAL DOSAGE FORMS SCALE-UP AND POSTAPPROVAL CHANGES: CHEMISTRY, MANUFACTURING, AND CONTROLS. IN VITRO DISSOLUTION TESTING AND IN VIVO BIOEQUIVALENCE DOCUMENTATION.. OCT 06, 1997.
US FDA. GUIDANCE. SUPAC-SS: NONSTERILE SEMISOLID DOSAGE FORMS. SCALE-UP AND POST-APPROVAL CHANGES: CHEMISTRY, MANUFACTURING AND CONTROLS. IN VITRO RELEASE TESTING AND IN VIVO BIOEQUIVALENCE DOCUMENTATION.. MAY 01, 1997.
US FDA. GUIDANCE. SUPPLEMENT TO 10/11/1984 LETTER ABOUT POLICIES, PROCEDURES AND IMPLEMENTATION OF THE ACT (Q&A FORMAT). MAR 02, 1998.
US FDA. GUIDANCE. SUPPLEMENTAL EXAMPLES FOR ILLUSTRATING STATISTICAL CONCEPTS DESCRIBED IN THE VICH IN VIVO BIOEQUALENCE. GL52. SEP 2014.
US FDA. GUIDANCE. SUPPLEMENTS FOR APPROVED PREMARKET APPROVAL (PMA) OR HUMANITARIAN DEVICE EXEMPTION (HDE) SUBMISSIONS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY (REVISED). MAY 2022.
US FDA. GUIDANCE. SUPPLEMENTS TO APPROVED APPLICATIONS FOR CLASS III MEDICAL DEVICES: USE OF PUBLISHED LITERATURE, USE OF PREVIOUSLY SUBMITTED MATERIALS, AND PRIORITY REVIEW . MAY 19, 1998.
US FDA. GUIDANCE. SUPPLY-CHAIN PROGRAM REQUIREMENTS AND CO-MANUFACTURER SUPPLIER APPROVAL AND VERIFICATION FOR HUMAN FOOD AND ANIMAL FOOD. NOV 2017.
US FDA. GUIDANCE. SURGICAL MASKS - PREMARKET NOTIFICATION [510(K)] SUBMISSIONS. MAR 04, 2004.
US FDA. GUIDANCE. SURGICAL STAPLERS AND STAPLES FOR INTERNAL USE - LABELING RECOMMENDATIONS. OCT 8, 2021.
US FDA. GUIDANCE. SURGICAL SUTURES - PERFORMANCE CRITERA FOR SAFETY AND PERFORMANCE BASED PATHWAY. APR 11, 2022.
US FDA. GUIDANCE. SURVEILLANCE AND DETENTION WITHOUT PHYSICAL EXAMINATION OF CONDOMS. JUL 11, 2008.
US FDA. GUIDANCE. SURVEILLANCE AND DETENTION WITHOUT PHYSICAL EXAMINATION OF SURGEONS’ AND/OR PATIENT EXAMINATION GLOVES. JUL 11, 2008.
US FDA. GUIDANCE. SURVEYING, LEVELING, AND ALIGNMENT LASER PRODUCTS. JAN 31, 2023.
US FDA. GUIDANCE. SYSTEMIC ANTIBACTERIAL AND ANTIFUNGAL DRUGS : SUSCEPTIBILITY TEST INTERPRETIVE CRITERIA LABELING FOR NDAS AND ANDAS. DEC 2017.
US FDA. GUIDANCE. SYSTEMIC LUPUS ERYTHEMATOSUS - DEVELOPING MEDICAL PRODUCTS FOR TREATMENT. JUN 2010.
US FDA. GUIDANCE. TABLET SCORING : NOMENCLATURE, LABELING, AND DATA FOR EVALUATION. MAR 2013.
US FDA. GUIDANCE. TARGET ANIMAL SAFETY AND EFFECTIVENESS PROTOCOL DEVELOPMENT AND SUBMISSION. #215. SEP 29, 2011.
US FDA. GUIDANCE. TARGET ANIMAL SAFETY DATA PRESENTATION AND STATISTICAL ANALYSIS. JAN 2016.
US FDA. GUIDANCE. TARGET ANIMAL SAFETY FOR VETERINARY PHARMACEUTICAL PRODUCTS. VICH GL43. #185.
US FDA. GUIDANCE. TECHNICAL CONSIDERATIONS FOR ADDITIVE MANUFACTURERED MEDICAL DEVICES. DEC 5, 2017.
US FDA. GUIDANCE. TECHNICAL CONSIDERATIONS FOR NON-CLINICAL ASSESSMENT OF MEDICAL DEVICES CONTAINING NITINOL. JUL 9, 2021.
US FDA. GUIDANCE. TECHNICAL CONSIDERATIONS FOR PEN, JET, AND RELATED INJECTORS INTENDED FOR USE WITH DRUGS AND BIOLOGICAL PRODUCTS. JUN 2013.
US FDA. GUIDANCE. TECHNICAL PERFORMANCE ASSESSMENT OF DIGITAL PATHOLOGY WHOLE SLIDE IMAGING DEVICES. APR 20, 2016.
US FDA. GUIDANCE. TECHNICAL PERFORMANCE ASSESSMENT OF QUANTITATIVE IMAGING IN DEVICE PREMARKET SUBMISSIONS. JUN 16, 2022.
US FDA. GUIDANCE. TECHNICAL SPECIFICATIONS FOR SUBMITTING CLINICAL TRIAL DATASETS FOR TREATMENT OF NONCIRRHOTIC NONALCOHOLIC STEATOHEPATITIS (NASH). JAN 2022.
US FDA. GUIDANCE. TEMPLATES FOR REPORTING TOXICOLOGY DATA. MAY 11, 2005.
US FDA. GUIDANCE. TEMPORARY POLICY DURING THE COVID-19 PUBLIC HEALTH EMERGENCY REGARDING THE QUALIFIED EXEMPTION FROM THE STANDARDS FOR THE GROWING, HARVESTING, PACKING, AND HOLDING OF PRODUCE FOR HUMAN CONSUMPTION. MAY 2020.
US FDA. GUIDANCE. TEMPORARY POLICY FOR COMPOUNDING OF CERTAIN DRUGS FOR HOSPITALIZED PATIENTS BY OUTSOURCING FACILITIES DURING THE COVID-19 PUBIC HEALTH EMERGENCY. MAY 21, 2020.
US FDA. GUIDANCE. TEMPORARY POLICY FOR COMPOUNDING OF CERTAIN DRUGS FOR HOSPITALIZED PATIENTS BY PHARMACY COMPOUNDERS NOT REGISTERED AS OUTSOURCING FACILITIES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. MAY 21, 2020.
US FDA. GUIDANCE. TEMPORARY POLICY ON PRESCRIPTION DRUG MARKETING ACT REQUIREMENTS FOR DISTRIBUTION OF DRUG SAMPLES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. JUN 2020.
US FDA. GUIDANCE. TEMPORARY POLICY ON REPACKAGING OR COMBINING PROPOFOL DRUG PRODUCTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCCY. APR 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING ACCREDITED THIRD-PARTY CERTIFICATION PROGRAM ONSITE OBSERVATION AND CERTIFICATE DURATION REQUIREMENTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING CERTAIN FOOD LABELING REQUIREMENTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY: MINOR FORMULATION CHANGES AND VENDING MACHINES. MAY 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING ENFORCEMENT OF 21 CFR PART 118 (THE EGG SAFETY RULE) DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING NON-STANDARD PPE PRACTICES FOR STERILE COMPOUNDING BY PHARMACY COMPOUNDERS NOT REGISTERED AS OUTSOURCING FACILITIES DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. MAY 14, 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING NUTRITION LABELING OF CERTAIN PACKAGED FOOD DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. MAR 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING NUTRITION LABELING OF STANDARD MENU ITEMS IN CHAIN RESTAURANTS AND SIMILAR RETAIL FOOD ESTABLISHMENTS DURING THE COVID-19 PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING PACKAGING AND LABELING OF SHELL EGGS SOLD BY RETAIL FOOD ESTABLISHMENTS DURIGN THE COVID-19 PUBLIC HEALTH EMERGENCY. APR 2020.
US FDA. GUIDANCE. TEMPORARY POLICY REGARDING PREVENTIVE CONTROLS AND FSVP FOOD SUPPLIER VERIFICATION ONSITE AUDIT REQUIREMENTS URING THE COVID-19 PUBLIC HEALTH EMERGENCY. JUN 2020.
US FDA. GUIDANCE. TESTICULAR TOXICITY : EVALUTION DURING DRUG DEVELOPMENT. OCT 2018.
US FDA. GUIDANCE. TESTING AND LABELING MEDICAL DEVICES FOR SAFETY IN THE MAGNETIC RESONANCE (MR) ENVIRONMENT. MAY 20, 2021.
US FDA. GUIDANCE. TESTING FOR BIOTIN INTERFERENCE IN IN VITRO DIAGNOSTIC DEVICES. OCT 2020.
US FDA. GUIDANCE. TESTING FOR SALMONELLA SPECIES IN HUMAN FOODS AND DIRECT-HUMAN-CONTACT ANIMAL FOODS. MAR 2012.
US FDA. GUIDANCE. TESTING GUIDANCE FOR MALE CONDOMS MADE FROM NEW MATERIAL (NON-LATEX). JUN 28, 1995.
US FDA. GUIDANCE. TESTING OF GLYCERIN FOR DIETHYLENE GLYCOL. ACCESSED : MAY 2007.
US FDA. GUIDANCE. TESTING OF RETROVIRAL VECTOR-BASED HUMAN GENE THERAPY PRODUCTS FOR REPLICATION COMPETENT RETROVIRUS DURING PRODUCT MANUFACTURE AND PATIENT FOLLOW-UP. JAN 2020.
US FDA. GUIDANCE. THE “DEEMED TO BE A LICENSE” PROVISION OF THE BPCI ACT. QUESTIONS AND ANSWERS. MAR 2020.
US FDA. GUIDANCE. THE 510(K) PROGRAM : EVALUATING SUBSTANTIAL EQUIVALENCE IN PREMARKET NOTIFICATIONS. JUL 28, 2014.
US FDA. GUIDANCE. THE ABBREVIATED 510(K) PROGRAM. SEP 13, 2019.
US FDA. GUIDANCE. THE ACCREDITATION SCHEME FOR CONFORMITY ASSESSMENT (ASCA) PILOT PROGRAM. SEP 25, 2020.
US FDA. GUIDANCE. THE CONTENT OF INVESTIGATIONAL DEVICE EXEMPTION (IDE) AND PREMARKET APPROVAL (PMA) APPLICATIONS FOR ARTIFICIAL PANCREAS DEVICE SYSTEMS. NOV 9, 2012.
US FDA. GUIDANCE. THE DECLARATION OF ADDED SUGARS ON HONEY, MAPLE SYRUP, OTHER SINGLE-INGREDIENT SUGARS AND SYRUPS, AND CERTAIN CRANBERRY PRODUCTS. JUN 2019.
US FDA. GUIDANCE. THE DECLARATION OF ALLULOSE AND CALORIES FROM ALLULOSE ON NUTRITION AND SUPPLEMENT FACTS LABELS. OCT 2020.
US FDA. GUIDANCE. THE DECLARATION OF CERTAIN SIOLATED OR SYNTHETIC NON-DIGESTIBLE CARBOHYDRATES AS DIETARY FIBER ON NUTRITION AND SUPPLEMENT FACTS LABELS. JUN 2018.
US FDA. GUIDANCE. THE FDA FOOD SAFETY MODERNIZATION ACT. EXTENSION AND CLARIFICATION OF COMPLIANCE DATES FOR CERTAIN PROVISIONS OF FOUR IMPLEMENTING RULES : WHAT YOU NEED TO KNOW ABOUT THE FDA REGULATION. SMALL ENTITY COMPLIANCE GUIDE. MAY 2018.
US FDA. GUIDANCE. THE INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES. APR 2018.
US FDA. GUIDANCE. THE INDEX OF LEGALLY MARKETED UNAPPROVED NEW ANIMAL DRUGS FOR MINOR SPECIES. JUL 2014.
US FDA. GUIDANCE. THE JUDICIOUS USE OF MEDICALLY IMPORTANT ANTIMICROBIAL DRUGS IN FOOD-PRODUCING ANIMALS. #209. APR 13, 2012.
US FDA. GUIDANCE. THE LEAST BURDENSOME PROVISIONS : CONCEPT AND PRINCIPLES. FEB 5, 2019.
US FDA. GUIDANCE. THE MAMMOGRAPHY QUAITY STANDARDS ACT FINAL REGULATIONS : MODIFICATIONS AND ADDITIONS TO POLICY GUIDANCE HELP SYSTEM #12. FEB 2, 2007.
US FDA. GUIDANCE. THE MAMMOGRAPHY QUALITY STANDARDS ACT FINAL REGULATIONS : MODIFICATIONS AND ADDITIONS TO OLICY GUIDANCE HELP SYSTEM #13. NOV 16, 2010.
US FDA. GUIDANCE. THE MEANING OF “SPOUSE” AND “FAMILY” IN FDA’S REGULATIONS AFTER THE SUPREME COURT’S RULING IN UNITED STATES V. WINDSOR - QUESTIONS AND ANSWERS. APR 2014.
US FDA. GUIDANCE. THE OPEN PUBLIC HEARING AT THE FDA ADVISORY COMMITTEE MEETINGS. MAY 15, 2013.
US FDA. GUIDANCE. THE PROHIBITION OF DISTRIBUTING FREE SAMPLES OF TOBACCO PRODUCTS (REVISED)*. MAR 2023.
US FDA. GUIDANCE. THE RADIOACTIVE DRUG RESEARCH COMMITTEE : HUMAN RESEARCH WITHOUT AN INVESTIGATIONAL ENW DRUG APPLICATION. AUG 2010.
US FDA. GUIDANCE. THE REVIEW AND INSPECTION OF PREMARKET APPROVAL APPLICATION MANUFACTURING INFORMATION AND OPERATIONS. JAN 8, 2008.
US FDA. GUIDANCE. THE SEAFOOD LIST. JULY 2012.
US FDA. GUIDANCE. THE SPECIAL 510(K) PROGRAM. SEP 13, 2019.
US FDA. GUIDANCE. THE USE OF AN ALTERNATE NAME FOR POTASSIUM CHLORIDE IN FOOD LABELING. DEC 2020.
US FDA. GUIDANCE. THE USE OF CLINICAL HOLDS FOLLOWING CLINICAL INVESTIGATOR MISCONDUCT AND CLINICAL INVESTIGATORS. SEP 02, 2004.
US FDA. GUIDANCE. THE USE OF MECHANICAL CALIBRATION OF DISSOLUTION APPARATUS 1 AND 2 - CURRENT GOOD MANUFACTURING PRACTICE (CGMP). JAN 2010.
US FDA. GUIDANCE. THE USE OF PUBLISHED LITERATURE IN SUPPORT OF NEW ANIMAL DRUG APPROVALS. #106. MAR 2023.
US FDA. GUIDANCE. THERMAL ENDOMETRIAL ABLATION DEVICES (SUBMISSION GUIDANCE FOR AN IDE). MAR 13, 1996.
US FDA. GUIDANCE. THIRD OF A SERIES OF LETTERS REGARDING THE IMPLEMENTATION OF THE ACT. MAR 02, 1998.
US FDA. GUIDANCE. THIRD PARTY REVIEW GUIDANCE FOR PHACOFRAGMENTATION SYSTEM DEVICE PREMARKET NOTIFICATION (510(K)). JAN 31, 1997.
US FDA. GUIDANCE. THIRD PARTY REVIEW GUIDANCE FOR VITREOUS ASPIRATION AND CUTTING DEVICE PREMARKET NOTIFICATION (510(K)). JAN 30, 1997.
US FDA. GUIDANCE. THIRD-PARTY CERTIFICATION BODY ACCREDITATION FOR FOOD SAFETY AUDITS : MODEL ACCREDITATION STANDARDS. FEB 2022.
US FDA. GUIDANCE. TIME AND EXTENT APPLICATIONS FOR NONPRESCRIPTION DRUG PRODUCTS. SEP 2011.
US FDA. GUIDANCE. TOBACCO PRODUCT MADSTER FILES. MAY 2016.
US FDA. GUIDANCE. TOBACCO PRODUCTS : PRINCIPLES FOR DESIGNING AND CONDUCTING TOBACCO PRODUCT PERCEPTION AND INTENTION STUDIES. AUG 2022.
US FDA. GUIDANCE. TOBACCO RETAILER TRAINING PROGRAMS. AUG 2018.
US FDA. GUIDANCE. TOLL-FREE NUMBER LABELING AND RELATED REQUIREMENTS FOR OVER-THE-COUNTER AND PRESCRIPTION DRUGS MARKETED WITH APPROVED APPLICATIONS. SMALL ENTITY COMPLIANCE GUIDE. JUN 2012.
US FDA. GUIDANCE. TONOMETERS - PREMARKET NOTIFICATION [510(K)] SUBMISSIONS. MAR 27, 2006.
US FDA. GUIDANCE. TOPICAL ACNE DRUG PRODUCTS FOR OVER-THE-COUNTER HUMAN USE - REVISION OF LABELING NAD CLASSIFICATION OF BENZOYL PEROXIDE AS SAFE AND EFFECTIVE. SMALL ENTITY COCMPLIANCE GUIDE. JAN 2011.
US FDA. GUIDANCE. TOXICITY GRADING SCALE FOR HEALTHY ADULT AND ADOLESCENT VOLUNTEERS ENROLLED IN PREVENTIVE VACCINE CLINICAL TRIALS. SEP 2007.
US FDA. GUIDANCE. TRANSITION PLAN FOR MEDICAL DEVICES ISSUED EMERGENCY USE AUTHORIZATIONS (EUAS) DURING THE CORNAVIRUS DISEASE 2019 (COVID-19) PUBLIC HEALTH EMERGENCY. MAR 27, 2023.
US FDA. GUIDANCE. TRANSITION PLAN FOR MEDICAL DEVICES THAT FALL WITHIN ENFORCEMENT POLICIES ISSUED DURING THE CORONAVIRUS DISEASE (2019 (COVID-19) PUBLIC HEALTH EMERGENCY. MAR 27, 2023.
US FDA. GUIDANCE. TREATMENT USE OF INVESTIGATIONAL DRUGS. JAN 01, 1998.
US FDA. GUIDANCE. TROPICAL DISEASE PRIORITY REVIEW VOUCHERS. OCT 2016.
US FDA. GUIDANCE. TWO-PHASED CHEMISTRY, MANUFACTURING, AND CONTROLS (CMC) TECHNICAL SECTIONS. SEP 2015.
US FDA. GUIDANCE. TYPES OF COMMUNICATION DURING THE REVIEW OF MEDICAL DEVICE SUBMISSIONS. APR 4, 2014.
US FDA. GUIDANCE. U.S. AGENT VOLUNTARY IDENTIFICATION SYSTEM (VIS) FOR FOOD FACILITY REGISTRATION. OCT 2020.
US FDA. GUIDANCE. ULTRAFILTERED MILK IN THE PRODUCTION OF STANDARDIZED CHEESES AND RELATED CHEESE PRODUCTS. AUG 2017.
US FDA. GUIDANCE. UNCOMPLICATED GONORRHEA : DEVELOPING DRUGS FOR TREATMENT. AUG 2015.
US FDA. GUIDANCE. UNCOMPLICATED URINARY TRACT INFECTIONS : DEVELOPING DRUGS FOR TREATMENT. AUG 2019.
US FDA. GUIDANCE. UNIFORM CONTRACEPTIVE LABELING . JUL 22, 1998.
US FDA. GUIDANCE. UNIQUE DEVICE IDENTIFER SYSTEM : FREQUENTLY ASKED QUESTIONS, VOL. 1. AUG 20, 2014.
US FDA. GUIDANCE. UNIQUE DEVICE IDENTIFICATION : CONVENIENCE KITS. APR 26, 2019.
US FDA. GUIDANCE. UNIQUE DEVICE IDENTIFICATION : POLICY REGARDING COMPLIANCE DATES FOR CLASS I AND UNCLASSIFIED DEVICES AND CERTAIN DEVICES REQUIRING DIRECT MARKING, AND GLOBAL UNIQUE DEVICE IDENTIFICATION DATABASE REQUIREMENTS FOR CERTAIN DEVICES. JUL 25, 2022.
US FDA. GUIDANCE. UNIQUE DEVICE IDENTIFICATION SYSTEM : FORM AND CONTENT OF THE UNIQUE DEVICE IDENTIFIER (UDI). JUL 7, 2021.
US FDA. GUIDANCE. UNIQUE DEVICE IDENTIFICATION SYSTEM : SMALL ENTITY COMPLIANCE GUIDE. AUG 13, 2014.
US FDA. GUIDANCE. UPDATING LABLEING FOR SUSCEPTABILITY TEST INFORMATION IN SYSTEMIC ANTIBACTERIAL DRUG PRODUCTS AND ANTIMICROBIAL SUSCEPTABILITY TESTING DEVICES. JUN 2009.
US FDA. GUIDANCE. UPGRADING CATEGORY III ANTIPERSPIRANTS TO CATEGORY I (43 FR 46728-46731). OCT 01, 1978.
US FDA. GUIDANCE. US INDUSTRY CONSENSUS STANDARD FOR THE UNIFORM LABELING OF BLOOD AND BLOOD COMPONENTS USING ISBT 128. JUN 2014.
US FDA. GUIDANCE. USE OF “LIGHT,” “MILD,” “LOW,” OR SIMILAR DESCRIPTORS IN THE LABEL, LABELING, OR ADVERTISING OF TOBACCO PRODUCTS. JUN 2010.
US FDA. GUIDANCE. USE OF ANIMAL CLONES AND CLONE PROGENY FOR HUMAN FOOD AND ANIMAL FEED. #179. JAN 15, 2008.
US FDA. GUIDANCE. USE OF DONOR SCREENING TESTS TO TEST DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS FOR INFECTION WITH TREPONEMA PALLIDUM (SYPHILIS). SEP 2015.
US FDA. GUIDANCE. USE OF ELECTRONIC HEALTH RECORD DATA IN CLINICAL INVESTIGATIONS. JUL 2018.
US FDA. GUIDANCE. USE OF INTERNATIONAL STANDARD ISO 10993-1, “BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 1 : EVALUATION AND TESTING WITHIN A RISK MANAGEMENT PROCESS. SEP 4, 2020.
US FDA. GUIDANCE. USE OF MATERIAL FROM DEER AND ELK IN ANIMAL FEED. #158. MAR 2016.
US FDA. GUIDANCE. USE OF NANOMATERIALS IN FOOD FOR ANIMALS. AUG 2015.
US FDA. GUIDANCE. USE OF NUCLEIC ACID TESTS ON POOLED AND INDIVIDUAL SAMPLES FROM DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS (INCLUDING SOURCE PLASMA AND SOURCE LEUKOCYTES) TO ADEQUATELY AND APPROPRIATELY REDUCE THE RISK OF TRANSMISSION OF OF HIV-1 AND HCV. OCT 21, 2004.
US FDA. GUIDANCE. USE OF NUCLEIC ACID TESTS ON POOLED AND INDIVIDUAL SAMPLES FROM DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS, INCLUDING SOURCE PLASMA TO REDUCE THE RISK OF TRANSMISSION OF HEPATITIS B VIRUS. OCT 2012.
US FDA. GUIDANCE. USE OF NUCLEIC ACID TESTS TO REDUCE THE RISK OF TRANSMISSION OF HEPATITIS B VIRUS FROM DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS. AUG 2016.
US FDA. GUIDANCE. USE OF NUCLEIC ACID TESTS TO REDUCE THE RISK OF TRANSMISSION OF WEST NILE VIRUS FROM DONORS OF WHOLE BLOOD AND BLOOD COMPONENTS INTENDED FOR TRANSFUSION. NOV 2009.
US FDA. GUIDANCE. USE OF NUCLEIC ACID TESTS TO REDUCE THE RISK OF TRANSMISSION OF WEST NILE VIRUS FROM LIVING DONORS OF HUMAN CELLS, TISSUES, AND CELLULAR AND TISSUE-BASED PRODUCTS (HCT/PS). MAY 2017.
US FDA. GUIDANCE. USE OF PUBLIC HUMAN GENETIC VARIANT DATABASES TO SUPPORT CLINICAL VALIDITY FOR GENETIC AND GENOMIC-BASED IN VITRO DIAGNOSTICS. APR 13, 2018.
US FDA. GUIDANCE. USE OF REAL-WORLD DATA AND REAL WORLD EVIDENCE TO SUPPORT EFFECTIVENESS OF NEW ANIMAL DRUGS. #266. OCT 2021.
US FDA. GUIDANCE. USE OF REAL-WORLD EVIDENCE TO SUPPORT REGULATORY DECISION-MAKING FOR MEDICAL DEVICES. AUG 31, 2017.
US FDA. GUIDANCE. USE OF RECYCLED PLASTICS IN FOOD PACKAGING (CHEMISTRY CONSIDERATIONS). JUL 2021.
US FDA. GUIDANCE. USE OF SEROLOGICAL TESTS TO REDUCE THE RISK OF TRANSFUSION-TRANSMITTED HUMAN T-LYMPHOTROPIC VIRUS TYPES I AND II (HTLV-1/II). FEB 2020.
US FDA. GUIDANCE. USE OF SEROLOGICAL TESTS TO REDUCE THE RISK OF TRANSMISSION OF TRYPANOSOMA CRUZI INFECTION IN BLOOD AND BLOOD COMPONENTS. DEC 2017.
US FDA. GUIDANCE. USE OF STERILE CONNECTING DEVICES IN BLOOD BANK PRACTICES. NOV 22, 2000.
US FDA. GUIDANCE. USE OF THE SEAFOOD LIST TO DETERMINE ACCEPTABLE SEAFOOD NAMES. SEC. 540.750 COMPLIANCE POLICY GUIDE. JUL 2020.
US FDA. GUIDANCE. USE OF THE TERM “HEALTHY” IN THE LABELING OF HUMAN FOOD PRODUCTS. SEP 2016.
US FDA. GUIDANCE. USE OF THE TERMS “BROWN KING CRAB” AND “GOLDEN KING CRAB” IN THE LABELING OF HUMAN FOOD PRODUCTS. NOV 2017.,
US FDA. GUIDANCE. USE OF TRACERS IN ANIMAL FOOD, TYPE A MEDICATED ARTICLES, AND MEDICATED FEEDS. #258. OCT 2022.
US FDA. GUIDANCE. USE OF WATER BY FOOD MANUFACTURERS IN AREAS SUBJECT TO A BOIL-WATER ADVISORY. MAY 2010.
US FDA. GUIDANCE. USEFUL WRITTEN CONSUMER MEDICATION INFORMATION (CMI). JUL 18, 2006.
US FDA. GUIDANCE. USER FEE WAIVERS FOR FDC AND CO-PACKAGED HIV DRUGS FOR PEPFAR. FEB 2007.
US FDA. GUIDANCE. USER FEE WAIVERS, REDUCTIONS, AND REFUNDS FOR DRUG AND BIOLOGICAL PRODUCTS. SEP 2011.
US FDA. GUIDANCE. USER FEES AND REFUNDS FOR DE NOVO CLASSIFICATION REQUESTS. OCT 5, 2022.
US FDA. GUIDANCE. USER FEES AND REFUNDS FOR PREMARKET APPROVAL APPLICATIONS AND DEVICE BIOLOGICS LICENSE APPLICATIONS. OCT 5, 2022.
US FDA. GUIDANCE. USER FEES AND REFUNDS FOR PREMARKET NOTIFICATION SUBMISSIONS (510(K)S). OCT 5, 2022.
US FDA. GUIDANCE. USER FEES FOR 513(G) REQUESTS FOR INFORMATION. OCT 5, 2022.
US FDA. GUIDANCE. USER INSTRUCTION FOR MEDICAL PRODUCTS (LASER NOTICE 44). AUG 11, 1995.
US FDA. GUIDANCE. USER INSTRUCTION HAZARD WARNINGS (LASER NOTICE 35). FEB 05, 1985.
US FDA. GUIDANCE. USER INSTRUCTIONS - MULTI AXIS WORKSTATIONS (LASER NOTICE 39). JUN 24, 1987.
US FDA. GUIDANCE. USER LABELING FOR DEVICES THAT CONTAIN NATURAL RUBBER (21 CFR 801.437).. APR 01, 2003.
US FDA. GUIDANCE. USING A CENTRALIZED IRB REVIEW PROCESS IN MULTICENTER CLINICAL TRIALS. MAR 16, 2006.
US FDA. GUIDANCE. USING ELECTRONIC MEANS TO DISTRIBUTE CERTAIN PRODUCT INFORMATION. FEB 28, 2006.
US FDA. GUIDANCE. UTILIZING ANIMAL STUDIES TO EVALUATE ORGAN PRESERVATION DEVICES. MAY 8, 2019.
US FDA. GUIDANCE. VAGINAL MICROBICIDES : DEVELOPMENT FOR THE PREVENTION OF HIV INFECTION. NOV 2014.
US FDA. GUIDANCE. VALIDATION OF PROCEDURES FOR PROCESSING OF HUMAN TISSUES INTENDED FOR TRANSPLANTATION. MAR 08, 2002.
US FDA. GUIDANCE. VARIANCE FROM MANUFACTURER REPORT NUMBER FORMAT - NO. 5. AUG 11, 1996.
US FDA. GUIDANCE. VARIANCE FROM MANUFACTURER REPORT NUMBER FORMAT [MDR LETTER]. JUL 15, 1996.
US FDA. GUIDANCE. VARIATIONS IN DRUG PRODUCTS THAT MAY BE INCLUDED IN A SINGLE ANDA. DEC 01, 1998.
US FDA. GUIDANCE. VETERINARY FEED DIRECTIVE. COMMON FORMAT. #233, QUESTIONS AND ANSWERS. SEP 2016.
US FDA. GUIDANCE. VIEWING OPTICS - SIGHTING TELESCOPE (LASER NOTICE 8). AUG 05, 1976.
US FDA. GUIDANCE. VOCAL FOLD MEDIALIZATION DEVICES - PREMARKET NOTIFICATION [510(K)] SUBMISSIONS. FEB 12, 2004.
US FDA. GUIDANCE. VOLUME LIMITS FOR AUTOMATED COLLECTION OF SOURCE PLASMA. NOV 04, 1992.
US FDA. GUIDANCE. VOLUNTARY LABELING INDICATING WHETHER FOODS HAVE OR HAVE NOT BEEN DERIVED FROM GENETICALLY ENGINEERED PLANTS. REVISED. MAR 2019.
US FDA. GUIDANCE. VOLUNTARY QUALIFIED IMPORTER PROGRAM. MAR 2022.
US FDA. GUIDANCE. VOLUNTARY SODIUM REDUCTION GOALS: TARGET MEAN AND UPPER BOUND CONCENTRATIONS FOR SODIUM IN COMMERCIALLY PROCESSED, PACKAGED, AND PREPARED FOODS. OCT 2021.
US FDA. GUIDANCE. VOTING PROCEDURES FOR ADVISORY COMMITTEE MEETINGS. AUG 2008.
US FDA. GUIDANCE. VULVOVAGINAL CANDIDIASIS : DEVELOPING DRUGS FOR TREATMENT. AUG 2019.
US FDA. GUIDANCE. WAIVER OF IRB REQUIREMENTS FOR DRUG AND BIOLOGICAL PRODUCT STUDIES. OCT 2017.
US FDA. GUIDANCE. WALK-IN WORKSTATIONS (LASER NOTICE 37). OCT 21, 1985.
US FDA. GUIDANCE. WARNING LABELS FOR DYE AND MULTIPLE WAVELENGTH LASERS (LASER NOTICE 16). MAR 02, 1977.
US FDA. GUIDANCE. WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS, AND BOXED WARNING SECTIONS OF LABELING FOR HUMAN PRESCRIPTION DRUG AND BIOLOGICAL PRODUCTS - CONTENT AND FORMAT. OCT 2011.
US FDA. GUIDANCE. WHAT YOU NEED TO KNOW ABOUT ADMINISTRATIVE DETENTION OF FOODS. SMALL ENTITY COMPLIANCE GUIDE. MAR 2013.
US FDA. GUIDANCE. WHAT YOU NEED TO KNOW ABOUT ESTABLISHMENT, MAINTENANCE, AND AVAILABILITY OF RECORDS. SMALL ENTITY COMPLIANCE GUIDE. APR 2014.
US FDA. GUIDANCE. WHAT YOU NEED TO KNOW ABOUT PRIOR NOTICE OF IMPORTED FOOD SHIPMENTS. AUG 2011.
US FDA. GUIDANCE. WHAT YOU NEED TO KNOW ABOUT THE FDA REGULATION : CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR FOOD FOR ANIMALS (21 CFR PART 507). #241. OCT 2016.
US FDA. GUIDANCE. WHAT YOU NEED TO KNOW ABOUT THE FDA REGULATION : CURRENT GOOD MANUFACTURING PRACTICE, HAZARD ANALYSIS, AND RISK-BASED PREVENTIVE CONTROLS FOR HUMAN FOOD (21 CFR PART 117). SMALL ENTITY COMPLIANCE GUIDE. OCT 2016.
US FDA. GUIDANCE. WHOESALE DISTRIBUTOR VERIFICATION REQUIREMENT FOR SALEABLE RETURNED DRUG PRODUCT - COMPLIANCE POLICY. SEP 2019.
US FDA. GUIDANCE. WHOLESALE DISTRIBUTOR VERIFICATION REQUIREMENT FOR SALEABLE RETURNED DRUG PRODUCT AND DISPENSER VERIFICATION REQUIREMENTS WHEN INVESTING A SUSPECT OR ILLEGITIMATE PRODUCT. COMPLIANCE POLICIES. OCT 2020.
US FDA. GUIDANCE. WOMEN AND MINORITIES GUIDANCE REQUIREMENTS. JUL 20, 1998.
US FDA. GUIDANCE. WRITING DEAR DOCTOR LETTERS FOR RECALLS OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS (ICDS). JUL 19, 2007.
US FDA. GUIDANCE.IMPLEMENTATION OF SECTION 10809 OF THE FARM SECURITY AND INVESTMENT ACT OF 2002 REGARDING THE PETITION PROCESS TO REQUEST APPROVAL OF LABELING FOR FOODS THAT HAVE BEEN TREATED WITH IRRADIATION. OCT 07, 2002.
US FDA. GUIDDANCE. FDA RECORDS ACCESS AUTHORITY UNDER SECTIONS 414 AND 704 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT. APR 2014.
US FDA. HACCP PRINCIPLES AND APPLICATION GUIDELINES. ACCESSED : DEC 22, 2021.
US FDA. HOME USE TESTS. ACCESSED : MAR 23, 2022.
US FDA. HUMANITARIAN DEVICE EXEMPTION. ACCESSED : MAR 23, 2022.
US FDA. ICH CONSENSUS GUIDELINE. M5 DATA ELEMENTS AND STANDARDS FOR DRUG DICTIONARIES. SEP 06, 2005.
US FDA. INACTIVE INGREDIENTS IN APPROVED DRUG PRODUCTS SEARCH : FREQUENTLY ASKED QUESTIONS. ACCESSED : MAR 23, 2022.
US FDA. INDUSTRY LETTER. CONTINUATION OF A SERIES OF LETTERS COMMUNICATING INTERIM AND INFORMAL GENERIC DRUG POLICY AND GUIDANCE. AVAILABILITY OF POLICY AND PROCEDURE GUIDES, AND FURTHER OPERATIONAL CHANGES TO THE GENERIC DRUG REVIEW PROGRAM. JUN 01, 1990.
US FDA. INFORMATION ON ABACAVIR (MARKETED AS ZIAGEN) AND ABACVIR-CONTAINING MEDICATIONS. ACCESSED : NOV 12, 2021.
US FDA. INFORMATION SHEET GUIDANCE. FDA INSTITUTIONAL REVIEW BOARD INSPECTIONS. JAN 2006.
US FDA. INFORMATION SHEET GUIDANCE. FREQUENTLY ASKED QUESTIONS ABOUT MEDICAL DEVICES. JAN 2006.
US FDA. INFORMATION SHEET GUIDANCE. SIGNIFICANT RISK AND NONSIGNIFICANT RISK MEDICAL DEVICE STUDIES. JAN 2006.
US FDA. INSPECTION CLASSIFICATION DATABASE. ACCESSED : MAR 23, 2022.
US FDA. JYNNEOS. ACCESSED : MAY 24, 2022.
US FDA. LENALIDIOMIDE. SHARED SYSTEM REMS. ACCESSED : MAY 21, 2021.
US FDA. M2 : ECTD SPECIFICATION QUESTIONS & ANSWERS AND CHANGE REQUESTS COMPANION DOCUMENT. JUN 2013.
US FDA. MACITENTAN SHARED SYSTEM REMS. ACCESSED : NOV 12, 2021.
US FDA. MEDICAL DEVICE USER FEE AMENDMENTS (MDUFA)
US FDA. MEDICATION GUIDES (WEBPAGE). ACCESSED : MAR 23, 2022.
US FDA. MEDICINES FOR YOUR PET. ACCESSED : APR 16, 2022.
US FDA. MEDSUN : MEDICAL PRODUCT SAFETY NETWORK. ACCESSED : MAR 23, 2022.
US FDA. MULTIPLE FUNCTION DEVICE PRODUCTS : POLICY AND CONSIDERATIONS. JUL 29, 2020.
US FDA. NAMING OF DRUG PRODUCTS CONTAINING SALT DRUG SUBSTANCES. JUN 2015.
US FDA. NATIONAL DRUG CODE DATABASE BACKGROUND INFORMATION. ACCESSED : JAN 2, 2022.
US FDA. NDA CLASSIFICATION CODES.. MANUAL OF POLICIES AND PROCESSURES. MAPP 5018.2. ACCESSED : MAR 23, 2022.
US FDA. ORPHAN DRUG ACT - RELEVANT EXCERPTS. ACCESSED : NOV 8, 2022.
US FDA. OTAT LEARN.
US FDA. PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION ACT OF 2013 (PAHPRA). ACCESSED : MAY 26, 2021.
US FDA. PDUFA LEGISLATION AND BACKGROUND : PDUFA II. ACCESSED : JUN 6, 2022.
US FDA. PDUFA LEGISLATION AND BACKGROUND : PDUFA III. ACCESSED : JUN 6, 2022.
US FDA. PDUFA LEGISLATION AND BACKGROUND : PDUFA IV. ACCESSED : JUN 6, 2022.
US FDA. PDUFA V : FISCAL YEARS 2013 - 2017. ACCESSED : JUN 6, 2022.
US FDA. PDUFA VI : FISCAL YEARS 2018 - 2022. ACCESSED : JUN 6, 2022.
US FDA. PHYSICOCHEMICAL AND STRUCTURAL (Q3) CHARACTERIZATION OF TOPICAL DRUG PRODUCTS SUBMITTED IN ANDAS. OCT 2022.
US FDA. POST-APPROVAL STUDIES PROGRAM. ACCESSED : MAR 23, 2022.
US FDA. POSTMARKET REQUIREMENTS AND COMMITMENTS. ACCESSED (WEBPAGE): MAR 23, 2022.
US FDA. PREMARKET APPROVAL (PMA) SUMMARY REVIEW MEMOS FOR 180-DAY DESIGN CHANGES (WEBPAGE). ACCESSED : MAR 23, 2022.
US FDA. PREMARKET APPROVAL. ACCESSED : MAR 23, 2022.
US FDA. PREMARKET ASSESSMENT OF PEDIATRIC MEDICAL DEVICES. MAR 24, 2014.
US FDA. PRESCRIPTION DRUG USER FEE AMENDMENTS. ACCESSED : JAN 4, 2022.
US FDA. PRESIDENT’S EMERGENCY PLAN FOR AIDS RELIEF (PEPFAR). ACCESSED : MAR 23, 2022.
US FDA. PRODUCT CODE CLASSIFICATION DATABASE. ACCESSED : MAR 23, 2022.
US FDA. PRODUCT CODES FOR RADIATION-EMITTING ELECTRONIC PRODUCTS. ACCESSED : MAR 23, 2022.
US FDA. PS-LENALIDOMIDE. SHARED SYSTEM REMS. ACCESSED : OCT 14, 2021.
US FDA. QUESTIONS AND ANSWERS ON FDA’S ADVERSE EVENT REPORTING SYSTEM (FAERS). ACCESSED : MAR 23, 2022.
US FDA. QUESTIONS. DRUG PRODUCT TRACING : THE EFFECT OF SECTION 585 OF THE FD&C ACT. QUESTIONS AND ANSWERS. FEB 2022.
US FDA. RECOMMENDATIONS FOR THE SUBMISSION OF LOINC(R) CODES IN REGULATORY APPLICATIONS TO THE U.S. FOOD AND DRUG ADMINISTRATION. NOV 2017.
US FDA. RECONDITIONING. ACCESSED : MAR 30, 2022.
US FDA. REDBOOK 2000 : I INTRODUCTION. JUL 2007.
US FDA. REDBOOK 2000 : III RECOMMENDED TOXICITY STUDIES. JUL 2007.
US FDA. REDBOOK 2000 : IV.B.2. GUIDELINES FOR REPORTING THE RESULTS OF TOXICITY STUDIES. APR 2007.
US FDA. REDBOOK 2000 : IV.C.1. SHORT-TERM TESTS FOR GENETIC TOXICITY. JUL 2007.
US FDA. REDBOOK 2000 : IV.C.8. IN-UTERO EXPOSURE PHASE FOR ADDITION TO CARCINOGENICITY STUDIES OR CHRONIC TOXICITY STUDIES WITH RODENTS. JUL 2007.
US FDA. REGENERATIVE MEDICINE ADVANCED THERAPY DESIGNATION. ACCESSED : JAN 6, 2022.
US FDA. REMS DOCUMENT. TECHNICAL CONFORMANCE GUIDE. TECHNICAL SPECIFICATIONS DOCUMENT. JAN 2023.
US FDA. REVISED DRAFT GUIDANCE. DISTRIBUTING SCIENTIFIC AND MEDICAL PULBICATIONS ON UNAPPROVED NEW USES - RECOMMENDED PRACTICES. FEB 2014.
US FDA. S5(R3) DETECTION AND REPRODUCTIVE AND DEVELOPMENTAL TOXICITY FOR HUMAN PHARMACEUTICALS. MAY 2021. REV. 3.
US FDA. SAFETY TESTING OF DRUG METABOLITES. MAR 2020.
US FDA. SMALL ENTITY COMPLIANCE GUIDE : BOTTLED WATER AND RESIDUAL DISINFECTANTS AND DISINFECTION BYPRODUCTS. JUN 2009.
US FDA. SMALL ENTITY COMPLIANCE GUIDE : BOTTLED WATER AND TOTAL COLIFORM AND E. COLI. MAR 2010.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. BOTTLED WATER AND ARSENIC. APR 2009.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. BOTTLED WATER AND URANIUM. APR 2009.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. CURRENT GOOD MANUFACTURING PRACTICE IN MANUFACTURING, PACKAGING, LABELING, OR HOLDING OPERATIONS FOR DIETARY SUPPLEMENTS. DEC 2010.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. DECLARATION BY NAME ON THE LABEL OF ALL FOODS AND COSMETIC PRODUCTS THAT CONTAIN COCHINEAL EXTRACT AND CARMINE. APR 2009.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. FINAL RULE DECLARING DIETARY SUPPLEMENTS CONTAINING EPHEDRINE ALKALOIDS ADULTERATED BECAUSE THEY PRESENT AN UNREASONABLE RISK. JUL 2008.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. HEALTH CLAIMS ON CALCIUM AND OSTEOPOROSIS AND CALCIUM VITAMIN D, AND OSTEOPOROSIS. MAY 2009.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. LABORATORY ACCREDITATION FOR ANALYSES OF FOODS : WHAT YOU NEED TO KNOW ABOUT THE FDA REGULATION. OCT 2022.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. NUTRIENT CONTENT CLAIMS DEFINITION FOR “HIGH POTENCY” AND DEFINITION FOR “ANTIOXIDANT” FOR USE IN NUTRIENT CONTENT CLAIMS FOR DIETARY SUPPLEMENTS AND CONVENTIONAL FOODS. JUL 2008.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. PREVENTION OF SALMONELLA ENTERITIDIS IN SHELL EGGS DURING PRODUCTION, TRANSPORTATION, AND STORAGE. APR 2010.
US FDA. SMALL ENTITY COMPLIANCE GUIDE. STANDARD OF IDENTIFY FOR WHITE CHOCOLATE. JUL 2008.
US FDA. STANDARDS AND CONFORMITY ASSESSMENT PROGRAM. ACCESSED : MAR 23, 2022.
US FDA. STUDY DATA TECHNICAL CONFORMANCE GUIDE. TECHNICAL SPECIFICATIONS DOCUMENT. OCT 2021.
US FDA. SUPPLEMENTAL DRAFT GUIDANCE. MITIGATION STRATEGIES TO PROTECT FOOD AGAINST INTENTIONAL ADULTERATION. FEB 2020.
US FDA. TECHNICAL SPECIFICATIONS DOCUMENT. BIORESEARCH MONITORING TECHNICAL CONFORMANCE GUIDE. JUL 27, 2020.
US FDA. TISSUE ESTABLISHMENT REGISTRATION. ACCESSED : MAR 23, 2022.
US FDA. UNIQUE DEVICE IDENTIFICATION : DIRECT MARKING OF DEVICES. NOV 17, 2017.
US FDA. USE OF ELECTRONIC INFORMED CONSENT. QUESTIONS AND ANSWERS. DEC 2016.
US FDA. USE OF INVESTIGATIONAL PRODUCTS WHEN SUBJECTS ENTER A SECOND INSTITUTION. JAN 1998.
US FDA. VACCINE DEVELOPMENT - 101. ACCESSED : MAR 23, 2022.
US FDA. WHAT IS A MEDICAL DEVICE RECALL? ACCESSED : MAR 23, 2022.
US NIH-GARD. UNCOMABLE HAIR SYNDROME. ACCESSED : FEB 27, 2022.
US NIH-NATIONAL HUMAN GENOME RESEARCH INSTITUTE. GENETIC INFORMATION NONDISCRIMINATION ACT (GINA). ACCESSED : JAN 26, 2023.
US NIH-NCI. 714-X (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. ABEMACICLIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ABIRATERONE ACETATE. ACCESSED : APR 11, 2022.
US NIH-NCI. ABVD. ACCESSED : APR 11, 2022.
US NIH-NCI. ABVE-PC. ACCESSED : APR 11, 2022.
US NIH-NCI. ABVE. ACCESSED : APR 11, 2022.
US NIH-NCI. AC-T. ACCESSED : APR 11, 2022.
US NIH-NCI. AC. ACCESSED : APR 11, 2022.
US NIH-NCI. ACALABRUTINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ACUPUNCTURE (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. ACUTE MYELOID LEUKEMIA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ADE. ACCESSED : APR 11, 2022.
US NIH-NCI. ADJUSTMENT TO CANCER: ANXIETY AND DISTRESS (PDQ®). ACCESSED : APR 8, 2022.|
US NIH-NCI. ADO-TRASTUZUMAB EMTANSINE. ACCESSED : APR 11, 2022.
US NIH-NCI. ADOLESCENTS AND YOUNG ADULTS WITH CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. ADRENOCORTICAL CARCINOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ADRENOCORTICAL CARCINOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. ADULT ACUTE LYMPHOBLASTIC LEUKEMIA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ADULT CENTRAL NERVOUS SYSTEM TUMORS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ADULT HODGKIN LYMPHOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ADULT NON-HODGKIN LYMPHOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ADULT PRIMARY LIVER CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ADULT SOFT TISSUE SARCOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. AFATINIB DIMALEATE. ACCESSED : APR 11, 2022.
US NIH-NCI. AIDS-RELATED LYMPHOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ALDESLEUKIN. ACCESSED : APR 11, 2022.
US NIH-NCI. ALECTINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ALEMTUZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. ALPELISIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ALVEOLAR SOFT PART SARCOMA (ASPS). ACCESSED : FEB 8, 2023.
US NIH-NCI. AMIFOSTINE. ACCESSED : APR 11, 2022.
US NIH-NCI. AMINOLEVULINIC ACID HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. AMIVANTAMAB-VMJW. ACCESSED : APR 11, 2022.
US NIH-NCI. ANAL CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. ANAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ANAL CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. ANASTROZOLE. ACCESSED : APR 11, 2022.
US NIH-NCI. ANTINEOPLASTONS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. APALUTAMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. APREPITANT. ACCESSED : APR 11, 2022.
US NIH-NCI. AROMATHERAPY WITH ESSENTIAL OILS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. ARSENIC TRIOXIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. ASCIMINIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. ASPARAGINASE ERWINIA CHRYSANTHEMI (RECOMBINANT)-RYWN. ACCESSED : APR 11, 2022.
US NIH-NCI. ASPARAGINASE ERWINIA CHRYSANTHEMI. ACCESSED : APR 11, 2022.
US NIH-NCI. ATEZOLIZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. AVAPRITINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. AVELUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. AXICABTAGENE CILOLEUCEL. ACCESSED : APR 11, 2022.
US NIH-NCI. AXITINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. AZACITIDINE. ACCESSED : APR 11, 2022.
US NIH-NCI. BEACOPP. ACCESSED : APR 11, 2022.
US NIH-NCI. BELANTAMAB MAFODOTIN-BLMF. ACCESSED : APR 11, 2022.
US NIH-NCI. BELINOSTAT. ACCESSED : APR 11, 2022.
US NIH-NCI. BELZUTIFAN. ACCESSED : APR 11, 2022.
US NIH-NCI. BENDAMUSTINE HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. BEP. ACCESSED : APR 11, 2022.
US NIH-NCI. BEVACIZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. BEXAROTENE. ACCESSED : APR 11, 2022.
US NIH-NCI. BICALUTAMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. BILE DUCT CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. BINIMETINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. BIRT-HOGG-DUBE SYNDROME (PDQ®) - HEALTH PROFESSIONAL VERSION. ACCESSED : JUN 2, 2022.
US NIH-NCI. BLACK COHOSH (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. BLADDER AND OTHER UROTHELIAL CANCERS SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. BLADDER CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. BLEOMYCIN SULFATE. ACCESSED : APR 11, 2022.
US NIH-NCI. BLINATUMOMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. BONE CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. BORTEZOMIB. ACCESSED : APR 11, 2022.
US NIH-NCI. BOSUTINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. BRAIN TUMOR. ACCESSED : APR 6, 2022.
US NIH-NCI. BREAST CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. BREAST CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. BREAST CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. BREAST CANCER TREATMENT DURING PREGNANCY (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. BREAST CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. BRENTUXIMAB VEDOTIN. ACCESSED : APR 11, 2022.
US NIH-NCI. BREXUCABTAGENE AUTOLEUCEL. ACCESSED : APR 11, 2022.
US NIH-NCI. BRIGATINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. BUMEL. ACCESSED : APR 11, 2022.
US NIH-NCI. BUSULFAN. ACCESSED : APR 11, 2022.
US NIH-NCI. CABAZITAXEL. ACCESSED : APR 11, 2022.
US NIH-NCI. CABOZANTINIB-S-MALATE. ACCESSED : APR 11, 2022.
US NIH-NCI. CAF. ACCESSED : APR 11, 2022.
US NIH-NCI. CALASPARGASE PEGOL-MKNL. ACCESSED : APR 11, 2022.
US NIH-NCI. CANCELL/CANTRON/PROTOCEL (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CANCER GENETICS OVERVIEW (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CANCER GENETICS RISK ASSESSMENT AND COUNSELING (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CANCER PAIN (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. CANCER PREVENTION OVERVIEW (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CANCER SCREENING OVERVIEW (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. CANCER THERAPY INTERACTIONS WITH FOODS AND DIETARY SUPPLEMENTS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CANCER-RELATED POST-TRAUMATIC STRESS (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. CANNABIS AND CANNABINOIDS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CAPECITABINE. ACCESSED : APR 11, 2022.
US NIH-NCI. CAPLACIZUMAB-YHDP. ACCESSED : APR 11, 2022.
US NIH-NCI. CAPMATINIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. CAPOX. ACCESSED : APR 11, 2022.
US NIH-NCI. CARBOPLATIN-TAXOL. ACCESSED : APR 11, 2022.
US NIH-NCI. CARBOPLATIN. ACCESSED : APR 11, 2022.
US NIH-NCI. CARCINOMA OF UNKNOWN PRIMARY TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. CARCINOMA OF UNKNOWN PRIMARY. ACCESSED : APR 6, 2022.
US NIH-NCI. CARDIOPULMONARY SYNDROMES (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. CARFILZOMIB. ACCESSED : APR 11, 2022.
US NIH-NCI. CARMUSTINE IMPLANT. ACCESSED : APR 11, 2022.
US NIH-NCI. CARMUSTINE. ACCESSED : APR 11, 2022.
US NIH-NCI. CARTILAGE (BOVINE AND SHARK) (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CEM. ACCESSED : APR 11, 2022.
US NIH-NCI. CEMIPLIMAB-RWLC. ACCESSED : APR 11, 2022.
US NIH-NCI. CERITINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. CERVICAL CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CERVICAL CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. CERVICAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. CETUXIMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. CEV. ACCESSED : APR 11, 2022.
US NIH-NCI. CHILDHOOD ACUTE LYMPHOBLASTIC LEUKEMIA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD ACUTE MYELOID LEUKEMIA AND OTHER MYELOID MALIGNANCIES TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD ADRENOCORTICAL CARCINOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD ASTROCYTOMAS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD BASAL CELL CARCINOMA AND SQUAMOUS CELL CARCINOMA OF THE SKIN TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD BLADDER CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD BRAIN AND SPINAL CORD TUMORS TREATMENT OVERVIEW (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD BREAST CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD BRONCHIAL TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD CANCER GENOMICS (PDQ®) - HEALTH PROFESSIONAL VERSION. ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD CANCERS. ACCESSED : APR 6, 2022.
US NIH-NCI. CHILDHOOD CARCINOMA OF UNKNOWN PRIMARY TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD CENTRAL NERVOUS SYSTEM ATYPICAL TERATOID - RHABDOID TUMOR TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD CENTRAL NERVOUS SYSTEM GERM CELL TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD CERVICAL AND VAGINAL CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD CHORDOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD COLORECTAL CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD CRANIOPHARYNGIOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD EPENDYMOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD ESOPHAGEAL CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD ESTHESIONEUROBLASTOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD EXTRACRANIAL GERM CELL TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD GASTROINTESTINAL CARCINOID TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD GASTROINTESTINAL STROMAL TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD GLIOMA BRAIN STEM TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD HEART TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD HODGKIN LYMPHOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD INTRAOCULAR (UVEAL) MELANOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD LARYNGEAL TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD LATE EFFECTS OF TREATMENT FOR CHILDHOOD CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD LIVER CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD MEDULLOBLASTOMA AND OTHER CENTRAL NERVOUS SYSTEM EMBRYONAL TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD MELANOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD MESOTHELIOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD MIDLINE TRACT CARCINOMA WITH NUT GENE CHANGES TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD MULTIPLE ENDOCRINE NEOPLASIATREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD NASOPHARYNGEAL CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD NON-HODGKIN LYMPHOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD ORAL CAVITY CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD OVARIAN CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD PANCREATIC CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD PHEOCHROMOCYTOMA AND PARAGANGLIOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD PLEUROPULMONARY BLASTOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD RHABDOMYOSARCOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD SALIVARY GLAND TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD STOMACH (GASTRIC) CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD TESTICULAR CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD THYMOMA AND THYMIC CARCINOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD THYROID CANCER TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD TRACHEOBRONCHIAL TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD VASCULAR TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. CHILDHOOD WILMS TUMOR AND OTHER CHILDHOOD KIDNEY TUMORS TREATMENT (PDQ®). ACCESSED : APR 9, 2022.|
US NIH-NCI. CHLORAMBUCIL-PREDNISONE. ACCESSED : APR 11, 2022.
US NIH-NCI. CHLORAMBUCIL. ACCESSED : APR 11, 2022.
US NIH-NCI. CHOP. ACCESSED : APR 11, 2022.
US NIH-NCI. CHRONIC LYMPHOCYTIC LEUKEMIA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. CHRONIC MYELOGENOUS LEUKEMIA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. CHRONIC MYELOPROLIFERATIVE NEOPLASMS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. CIGARETTE SMOKING: HEALTH RISKS AND HOW TO QUIT (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CILTACABTAGENE AUTOLEUCEL. ACCESSED : APR 11, 2022.
US NIH-NCI. CISPLATIN. ACCESSED : APR 11, 2022.
US NIH-NCI. CLADRIBINE. ACCESSED : APR 11, 2022.
US NIH-NCI. CLOFARABINE. ACCESSED : APR 11, 2022.
US NIH-NCI. CMF. ACCESSED : APR 11, 2022.
US NIH-NCI. COBIMETINIB FUMARATE. ACCESSED : APR 11, 2022.
US NIH-NCI. COENZYME Q10 (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. COGNITIVE IMPAIRMENT IN ADULTS WITH NON−CENTRAL NERVOUS SYSTEM CANCERS (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. COLON CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. COLORECTAL CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. COLORECTAL CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. COLORECTAL CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (CTCAE)
US NIH-NCI. COMMUNICATION IN CANCER CARE (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. COPANLISIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. COPDAC. ACCESSED : APR 11, 2022.
US NIH-NCI. COPP-ABV. ACCESSED : APR 11, 2022.
US NIH-NCI. COPP. ACCESSED : APR 11, 2022.
US NIH-NCI. CRIZOTINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. CURCUMIN (CURCUMA, TURMERIC) AND CANCER (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. CVP. ACCESSED : APR 11, 2022.
US NIH-NCI. CYCLOPHOSPHAMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. CYTARABINE. ACCESSED : APR 11, 2022.
US NIH-NCI. DABRAFENIB MESYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. DACARBAZINE. ACCESSED : APR 11, 2022.
US NIH-NCI. DACOMITINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. DACTINOMYCIN. ACCESSED : APR 11, 2022.
US NIH-NCI. DARATUMUMAB AND HYALURONIDASE-FIHJ. ACCESSED : APR 11, 2022.
US NIH-NCI. DARATUMUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. DARBEPOETIN ALFA. ACCESSED : APR 11, 2022.
US NIH-NCI. DAROLUTAMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. DASATINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. DAUNORUBICIN HYDROCHLORIDE AND CYTARABINE LIPOSOME. ACCESSED : APR 11, 2022.
US NIH-NCI. DAUNORUBICIN HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. DECITABINE AND CEDAZURIDINE. ACCESSED : APR 11, 2022.
US NIH-NCI. DECITABINE. ACCESSED : APR 11, 2022.
US NIH-NCI. DEFIBROTIDE SODIUM. ACCESSED : APR 11, 2022.
US NIH-NCI. DEGARELIX. ACCESSED : APR 11, 2022.
US NIH-NCI. DELIRIUM (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. DENILEUKIN DIFTITOX. ACCESSED : APR 11, 2022.
US NIH-NCI. DENOSUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. DEPRESSION (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. DEXAMETHASONE. ACCESSED : APR 11, 2022.
US NIH-NCI. DEXRAZOXANE HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. DINUTUXIMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. DOCETAXEL. ACCESSED : APR 11, 2022.
US NIH-NCI. DOSTARLIMAB-GXLY. ACCESSED : APR 11, 2022.
US NIH-NCI. DOXORUBICIN HYDROCHLORIDE LIPOSOME. ACCESSED : APR 11, 2022.
US NIH-NCI. DOXORUBICIN HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. DURVALUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. DUVELISIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ELOTUZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. ELTROMBOPAG OLAMINE. ACCESSED : APR 11, 2022.
US NIH-NCI. EMAPALUMAB-LZSG. ACCESSED : APR 11, 2022.
US NIH-NCI. ENASIDENIB MESYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. ENCORAFENIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ENDOMETRIAL CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. ENDOMETRIAL CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. ENDOMETRIAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ENFORTUMAB VEDOTIN-EJFV. ACCESSED : APR 11, 2022.
US NIH-NCI. ENTRECTINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ENZALUTAMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. EPIRUBICIN HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. EPOCH. ACCESSED : APR 11, 2022.
US NIH-NCI. EPOETIN ALFA. ACCESSED : APR 11, 2022.
US NIH-NCI. ERDAFITINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ERIBULIN MESYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. ERLOTINIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. ESOPHAGEAL CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. ESOPHAGEAL CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. ESOPHAGEAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. ESOPHAGEAL CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. ESSIAC/FLOR ESSENCE (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. ETOPOSIDE PHOSPHATE. ACCESSED : APR 11, 2022.
US NIH-NCI. ETOPOSIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. EVEROLIMUS. ACCESSED : APR 11, 2022.
US NIH-NCI. EWING SARCOMA AND UNDIFFERENTIATED SMALL ROUND CELL SARCOMAS OF BONE AND SOFT TISSUE TREATMENT TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. EXEMESTANE. ACCESSED : APR 11, 2022.
US NIH-NCI. EXTRAGONADAL GERM CELL TUMORS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. FAM-TRASTUZUMAB DERUXTECAN-NXKI. ACCESSED : APR 11, 2022.
US NIH-NCI. FATIGUE (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. FEC. ACCESSED : APR 11, 2022.
US NIH-NCI. FEDRATINIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. FILGRASTIM. ACCESSED : APR 11, 2022.
US NIH-NCI. FINANCIAL TOXICITY AND CANCER TREATMENT TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. FLUDARABINE PHOSPHATE. ACCESSED : APR 11, 2022.
US NIH-NCI. FLUOROURACIL (TOPICAL). ACCESSED : APR 11, 2022.
US NIH-NCI. FLUOROURACIL INJECTION. ACCESSED : APR 11, 2022.
US NIH-NCI. FLUTAMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. FOLFIRI-BEVACIZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. FOLFIRI-CETUXIMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. FOLFIRI. ACCESSED : APR 11, 2022.
US NIH-NCI. FOLFIRINOX. ACCESSED : APR 11, 2022.
US NIH-NCI. FOLFOX. ACCESSED : APR 11, 2022.
US NIH-NCI. FOSTAMATINIB DISODIUM. ACCESSED : APR 11, 2022.
US NIH-NCI. FU-LV. ACCESSED : APR 11, 2022.
US NIH-NCI. FULVESTRANT. ACCESSED : APR 11, 2022.
US NIH-NCI. GALLBLADDER CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. GALLBLADDER CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. GASTRIC CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. GASTROINTESTINAL CARCINOID TUMORS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. GASTROINTESTINAL CARCINOID TUMORS. ACCESSED : APR 6, 2022.
US NIH-NCI. GASTROINTESTINAL COMPLICATIONS (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. GASTROINTESTINAL STROMAL TUMORS TREATMENT (ADULT) (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. GEFITINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. GEMCITABINE HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. GEMCITABINE-CISPLATIN. ACCESSED : APR 11, 2022.
US NIH-NCI. GEMCITABINE-OXALIPLATIN. ACCESSED : APR 11, 2022.
US NIH-NCI. GEMTUZUMAB OZOGAMICIN. ACCESSED : APR 11, 2022.
US NIH-NCI. GENETICS OF BREAST AND GYNECOLOGIC CANCERS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. GENETICS OF COLORECTAL CANCER (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. GENETICS OF ENDOCRINE AND NEUROENDOCRINE NEOPLASIAS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. GENETICS OF PROSTATE CANCER (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. GENETICS OF RENAL CELL CARCINOMA (KIDNEY CANCER) (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. GENETICS OF SKIN CANCER (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. GERSON THERAPY (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. GESTATIONAL TROPHOBLASTIC DISEASE TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. GESTATIONAL TROPHOBLASTIC DISEASE. ACCESSED : APR 6, 2022.
US NIH-NCI. GILTERITINIB FUMARATE. ACCESSED : APR 11, 2022.
US NIH-NCI. GLASDEGIB MALEATE. ACCESSED : APR 11, 2022.
US NIH-NCI. GLUCARPIDASE. ACCESSED : APR 11, 2022.
US NIH-NCI. GONZALEZ REGIMEN (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. GOSERELIN ACETATE. ACCESSED : APR 11, 2022.
US NIH-NCI. GRANISETRON HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. GRANISETRON. ACCESSED : APR 11, 2022.
US NIH-NCI. GRIEF, BEREAVEMENT, AND COPING WITH LOSS (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. HAIRY CELL LEUKEMIA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. HEAD AND NECK CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. HEREDITARY PAPILLARY RENAL CARCINOMA (PDQ®) - HEALTH PROFESSIONAL VERSION. ACCESSED : JUN 2, 2022.
US NIH-NCI. HOT FLASHES AND NIGHT SWEATS (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. HPV NONAVALENT VACCINE, RECOMBINANT. ACCESSED : APR 11, 2022.
US NIH-NCI. HPV QUADRIVALENT VACCINE, RECOMBINANT. ACCESSED : APR 11, 2022.
US NIH-NCI. HYDRAZINE SULFATE (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. HYDROXYUREA. ACCESSED : APR 11, 2022.
US NIH-NCI. HYPER-CVAD. ACCESSED : APR 11, 2022.
US NIH-NCI. HYPOPHARYNGEAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. IBRITUMOMAB TIUXETAN. ACCESSED : APR 11, 2022.
US NIH-NCI. IBRUTINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ICE. ACCESSED : APR 11, 2022.
US NIH-NCI. IDARUBICIN HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. IDECABTAGENE VICLEUCEL . ACCESSED : APR 11, 2022.
US NIH-NCI. IDELALISIB. ACCESSED : APR 11, 2022.
US NIH-NCI. IFOSFAMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. IMATINIB MESYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. IMIQUIMOD. ACCESSED : APR 11, 2022.
US NIH-NCI. INFIGRATINIB PHOSPHATE. ACCESSED : APR 11, 2022.
US NIH-NCI. INFORMAL CAREGIVERS IN CANCER (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. INOTUZUMAB OZOGAMICIN. ACCESSED : APR 11, 2022.
US NIH-NCI. INTERFERON ALFA-2B, RECOMBINANT. ACCESSED : APR 11, 2022.
US NIH-NCI. INTRAOCULAR (EYE) MELANOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. INTRAOCULAR (EYE) MELANOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. INTRAVENOUS VITAMIN C. ACCESSED : APR 11, 2022.
US NIH-NCI. IOBENGUANE I 131. ACCESSED : APR 11, 2022.
US NIH-NCI. IPILIMUMAB. ACCESSED : APR 11, 2022.|
US NIH-NCI. IRINOTECAN HYDROCHLORIDE LIPOSOME. ACCESSED : APR 11, 2022.
US NIH-NCI. IRINOTECAN HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. ISATUXIMAB-IRFC. ACCESSED : APR 11, 2022.
US NIH-NCI. IVOSIDENIB. ACCESSED : APR 11, 2022.
US NIH-NCI. IXABEPILONE. ACCESSED : APR 11, 2022.
US NIH-NCI. IXAZOMIB CITRATE. ACCESSED : APR 11, 2022.
US NIH-NCI. JEB. ACCESSED : APR 11, 2022.
US NIH-NCI. KAPOSI SARCOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. KIDNEY (RENAL CELL) CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. LAETRILE/AMYGDALIN (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. LANGERHANS CELL HISTIOCYTOSIS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. LANGERHANS CELL HISTIOCYTOSIS. ACCESSED : APR 6, 2022.
US NIH-NCI. LANREOTIDE ACETATE. ACCESSED : APR 11, 2022.
US NIH-NCI. LAPATINIB DITOSYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. LAROTRECTINIB SULFATE. ACCESSED : APR 11, 2022.
US NIH-NCI. LARYNGEAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. LAST DAYS OF LIFE (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. LENALIDOMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. LENVATINIB MESYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. LETROZOLE. ACCESSED : APR 11, 2022.
US NIH-NCI. LEUCOVORIN CALCIUM. ACCESSED : APR 11, 2022.
US NIH-NCI. LEUKEMIA. ACCESSED : APR 6, 2022.
US NIH-NCI. LEUPROLIDE ACETATE. ACCESSED : APR 11, 2022.
US NIH-NCI. LIP AND ORAL CAVITY CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. LISOCABTAGENE MARALEUCEL. ACCESSED : APR 11, 2022.
US NIH-NCI. LIVER (HEPATOCELLULAR) CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. LIVER (HEPATOCELLULAR) CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. LIVER AND BILE DUCT CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. LOMUSTINE. ACCESSED : APR 11, 2022.
US NIH-NCI. LONCASTUXIMAB TESIRINE-LPYL. ACCESSED : APR 11, 2022.
US NIH-NCI. LORLATINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. LUNG CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. LUNG CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. LURBINECTEDIN. ACCESSED : APR 11, 2022.
US NIH-NCI. LUSPATERCEPT-AAMT. ACCESSED : APR 11, 2022.
US NIH-NCI. LUTETIUM LU 177 VIPIVOTIDE TETRAXETAN. ACCESSED : MAY 10, 2022.
US NIH-NCI. LUTETIUM LU 177-DOTATATE. ACCESSED : APR 11, 2022.
US NIH-NCI. LYMPHEDEMA (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. LYMPHOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. MALE BREAST CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. MALIGNANT MESOTHELIOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. MALIGNANT MESOTHELIOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. MARGETUXIMAB-CMKB. ACCESSED : APR 11, 2022.
US NIH-NCI. MECHLORETHAMINE HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. MEDICINAL MUSHROOMS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. MEGESTROL ACETATE. ACCESSED : APR 11, 2022.
US NIH-NCI. MELANOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. MELPHALAN HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. MELPHALAN. ACCESSED : APR 11, 2022.
US NIH-NCI. MERCAPTOPURINE. ACCESSED : APR 11, 2022.
US NIH-NCI. MERKEL CELL CARCINOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. MESNA. ACCESSED : APR 11, 2022.
US NIH-NCI. METASTATIC CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. METASTATIC SQUAMOUS NECK CANCER WITH OCCULT PRIMARY TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. METHOTREXATE SODIUM. ACCESSED : APR 11, 2022.
US NIH-NCI. METHYLNALTREXONE BROMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. MIDOSTAURIN. ACCESSED : APR 11, 2022.
US NIH-NCI. MILK THISTLE (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. MISTLETOE EXTRACTS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. MITOMYCIN . ACCESSED : APR 11, 2022.
US NIH-NCI. MITOXANTRONE HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. MOBOCERTINIB SUCCINATE. ACCESSED : APR 11, 2022.
US NIH-NCI. MOGAMULIZUMAB-KPKC. ACCESSED : APR 11, 2022.
US NIH-NCI. MOPP. ACCESSED : APR 11, 2022.
US NIH-NCI. MOXETUMOMAB PASUDOTOX-TDFK. ACCESSED : APR 11, 2022.
US NIH-NCI. MVAC. ACCESSED : APR 11, 2022.
US NIH-NCI. MYELODYSPLASTIC SYNDROMES TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. MYELODYSPLASTIC/MYELOPROLIFERATIVE NEOPLASMS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. MYELOPROLIFERATIVE NEOPLASMS. ACCESSED : APR 6, 2022.
US NIH-NCI. NASOPHARYNGEAL CANCER TREATMENT (ADULT) (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. NAUSEA AND VOMITING (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. NAXITAMAB-GQGK. ACCESSED : APR 11, 2022.
US NIH-NCI. NECITUMUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. NELARABINE. ACCESSED : APR 11, 2022.
US NIH-NCI. NERATINIB MALEATE. ACCESSED : APR 11, 2022.
US NIH-NCI. NETUPITANT AND PALONOSETRON HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. NEUROBLASTOMA CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. NEUROBLASTOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. NEUROBLASTOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. NEWCASTLE DISEASE VIRUS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. NILOTINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. NILUTAMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. NIRAPARIB TOSYLATE MONOHYDRATE. ACCESSED : APR 11, 2022.
US NIH-NCI. NIVOLUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. NON-SMALL CELL LUNG CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. NUTRITION IN CANCER CARE (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. OBINUTUZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. OEPA. ACCESSED : APR 11, 2022.
US NIH-NCI. OFATUMUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. OLAPARIB. ACCESSED : APR 11, 2022.
US NIH-NCI. OMACETAXINE MEPESUCCINATE. ACCESSED : APR 11, 2022.
US NIH-NCI. ONDANSETRON HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. OPPA. ACCESSED : APR 11, 2022.
US NIH-NCI. ORAL CAVITY AND NASOPHARYNGEAL CANCERS SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. ORAL CAVITY, OROPHARYNGEAL, HYPOPHARYNGEAL, AND LARYNGEAL CANCERS PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. ORAL COMPLICATIONS OF CHEMOTHERAPY AND HEAD/NECK RADIATION (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. OROPHARYNGEAL CANCER TREATMENT (ADULT) (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. OSIMERTINIB MESYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. OSTEOSARCOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. OVARIAN EPITHELIAL, FALLOPIAN TUBE, AND PRIMARY PERITONEAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. OVARIAN GERM CELL TUMORS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. OVARIAN LOW MALIGNANT POTENTIAL TUMORS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. OVARIAN, FALLOPIAN TUBE, AND PRIMARY PERITONEAL CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. OVARIAN, FALLOPIAN TUBE, AND PRIMARY PERITONEAL CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. OVARIAN, FALLOPIAN TUBE, AND PRIMARY PERITONEAL CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. OXALIPLATIN. ACCESSED : APR 11, 2022.
US NIH-NCI. PACLITAXEL ALBUMIN-STABILIZED NANOPARTICLE FORMULATION. ACCESSED : APR 11, 2022.
US NIH-NCI. PACLITAXEL. ACCESSED : APR 11, 2022.
US NIH-NCI. PACRITINIB CITRATE. ACCESSED : APR 11, 2022.
US NIH-NCI. PAD. ACCESSED : APR 11, 2022.
US NIH-NCI. PALBOCICLIB. ACCESSED : APR 11, 2022.
US NIH-NCI. PALIFERMIN. ACCESSED : APR 11, 2022.
US NIH-NCI. PALONOSETRON HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. PAMIDRONATE DISODIUM. ACCESSED : APR 11, 2022.
US NIH-NCI. PANCREATIC CANCER TREATMENT (ADULT) (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PANCREATIC CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. PANCREATIC NEUROENDOCRINE TUMORS (ISLET CELL TUMORS) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PANITUMUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. PARANASAL SINUS AND NASAL CAVITY CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PARATHYROID CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PARATHYROID CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. PAZOPANIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. PC-SPES (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. PCV. ACCESSED : APR 11, 2022.
US NIH-NCI. PEB. ACCESSED : APR 11, 2022.
US NIH-NCI. PEDIATRIC HEMATOPOIETIC STEM CELL TRANSPLANTATION AND CELLULAR THERAPY FOR CANCER (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. PEDIATRIC SUPPORTIVE CARE (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. PEGASPARGASE. ACCESSED : APR 11, 2022.
US NIH-NCI. PEGFILGRASTIM. ACCESSED : APR 11, 2022.
US NIH-NCI. PEGINTERFERON ALFA-2B. ACCESSED : APR 11, 2022.
US NIH-NCI. PEMBROLIZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. PEMETREXED DISODIUM. ACCESSED : APR 11, 2022.
US NIH-NCI. PEMIGATINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. PENILE CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PENILE CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF. ACCESSED : APR 11, 2022.
US NIH-NCI. PERTUZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. PEXIDARTINIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. PHEOCHROMOCYTOMA AND PARAGANGLIOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PHEOCHROMOCYTOMA AND PARAGANGLIOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. PITUITARY TUMORS TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PITUITARY TUMORS. ACCESSED : APR 6, 2022.
US NIH-NCI. PLANNING THE TRANSITION TO END-OF-LIFE CARE IN ADVANCED CANCER (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PLASMA CELL NEOPLASM (INCLUDING MULTIPLE MYELOMA). ACCESSED : APR 6, 2022.
US NIH-NCI. PLASMA CELL NEOPLASMS (INCLUDING MULTIPLE MYELOMA) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PLERIXAFOR. ACCESSED : APR 11, 2022.
US NIH-NCI. POLATUZUMAB VEDOTIN-PIIQ. ACCESSED : APR 11, 2022.
US NIH-NCI. POMALIDOMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. PONATINIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. PRALATREXATE. ACCESSED : APR 11, 2022.
US NIH-NCI. PRALSETINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. PREDNISONE. ACCESSED : APR 11, 2022.
US NIH-NCI. PRIMARY CNS LYMPHOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PROCARBAZINE HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. PROPRANOLOL HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. PROSTATE CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. PROSTATE CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. PROSTATE CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. PROSTATE CANCER, NUTRITION, AND DIETARY SUPPLEMENTS (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. PROSTATE CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. PRURITUS (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. R-CHOP. ACCESSED : APR 11, 2022.
US NIH-NCI. R-CVP. ACCESSED : APR 11, 2022.
US NIH-NCI. R-EPOCH. ACCESSED : APR 11, 2022.
US NIH-NCI. R-ICE. ACCESSED : APR 11, 2022.
US NIH-NCI. RADIUM 223 DICHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. RALOXIFENE HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. RAMUCIRUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. RARE CANCERS OF CHILDHOOD TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. RASBURICASE. ACCESSED : APR 11, 2022.
US NIH-NCI. RAVULIZUMAB-CWVZ. ACCESSED : APR 11, 2022.
US NIH-NCI. RECOMBINANT HPV BIVALENT VACCINE. ACCESSED : APR 11, 2022.
US NIH-NCI. RECTAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. RECURRENT CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. REGORAFENIB. ACCESSED : APR 11, 2022.
US NIH-NCI. RELUGOLIX. ACCESSED : APR 11, 2022.
US NIH-NCI. RENAL CELL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. RETINOBLASTOMA TREATMENT (PDQ®). ACCESSED : APR 9, 2022.
US NIH-NCI. RETINOBLASTOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. RIBOCICLIB. ACCESSED : APR 11, 2022.
US NIH-NCI. RIPRETINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. RITUXIMAB AND HYALURONIDASE HUMAN. ACCESSED : APR 11, 2022.
US NIH-NCI. RITUXIMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. ROLAPITANT HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. ROMIDEPSIN. ACCESSED : APR 11, 2022.
US NIH-NCI. ROMIPLOSTIM. ACCESSED : APR 11, 2022.
US NIH-NCI. ROPEGINTERFERON ALFA-2B-NJFT. ACCESSED : APR 11, 2022.
US NIH-NCI. RUCAPARIB CAMSYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. RUXOLITINIB PHOSPHATE. ACCESSED : APR 11, 2022.
US NIH-NCI. SACITUZUMAB GOVITECAN-HZIY. ACCESSED : APR 11, 2022.
US NIH-NCI. SALIVARY GLAND CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. SELECTED VEGETABLES/SUN'S SOUP (PDQ®). ACCESSED : APR 11, 2022.|
US NIH-NCI. SELINEXOR. ACCESSED : APR 11, 2022.
US NIH-NCI. SELPERCATINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. SELUMETINIB SULFATE. ACCESSED : APR 11, 2022.
US NIH-NCI. SILTUXIMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. SIPULEUCEL-T. ACCESSED : APR 11, 2022.
US NIH-NCI. SIROLIMUS PROTEIN-BOUND PARTICLES. ACCESSED : APR 11, 2022.
US NIH-NCI. SKIN CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.
US NIH-NCI. SKIN CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. SKIN CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. SKIN CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. SLEEP DISORDERS (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. SMALL CELL LUNG CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. SMALL INTESTINE CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. SMALL INTESTINE CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. SOFT TISSUE SARCOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. SONIDEGIB. ACCESSED : APR 11, 2022.
US NIH-NCI. SORAFENIB TOSYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. SOTORASIB. ACCESSED : APR 11, 2022.
US NIH-NCI. SPIRITUALITY IN CANCER CARE (PDQ®) TREATMENT (PDQ®). ACCESSED : APR 8, 2022.|
US NIH-NCI. STANFORD V. ACCESSED : APR 11, 2022.
US NIH-NCI. STOMACH (GASTRIC) CANCER PREVENTION (PDQ®). ACCESSED : APR 11, 2022.|
US NIH-NCI. STOMACH (GASTRIC) CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. STOMACH (GASTRIC) CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. SUNITINIB MALATE. ACCESSED : APR 11, 2022.
US NIH-NCI. TAC. ACCESSED : APR 11, 2022.
US NIH-NCI. TAFASITAMAB-CXIX. ACCESSED : APR 11, 2022.
US NIH-NCI. TAGRAXOFUSP-ERZS. ACCESSED : APR 11, 2022.
US NIH-NCI. TALAZOPARIB TOSYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. TALC. ACCESSED : APR 11, 2022.
US NIH-NCI. TALIMOGENE LAHERPAREPVEC. ACCESSED : APR 11, 2022.
US NIH-NCI. TAMOXIFEN CITRATE. ACCESSED : APR 11, 2022.
US NIH-NCI. TAZEMETOSTAT HYDROBROMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. TEBENTAFUSP-TEBN. ACCESSED : APR 11, 2022.
US NIH-NCI. TEMOZOLOMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. TEMSIROLIMUS. ACCESSED : APR 11, 2022.
US NIH-NCI. TEPOTINIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. TESTICULAR CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. TESTICULAR CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. TESTICULAR CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. THALIDOMIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. THIOGUANINE. ACCESSED : APR 11, 2022.
US NIH-NCI. THIOTEPA. ACCESSED : APR 11, 2022.
US NIH-NCI. THYMOMA AND THYMIC CARCINOMA TREATMENT (ADULT) (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. THYMOMA AND THYMIC CARCINOMA. ACCESSED : APR 6, 2022.
US NIH-NCI. THYROID CANCER SCREENING (PDQ®). ACCESSED : APR 12, 2022.
US NIH-NCI. THYROID CANCER TREATMENT (ADULT) (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. THYROID CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. TISAGENLECLEUCEL. ACCESSED : APR 11, 2022.
US NIH-NCI. TISOTUMAB VEDOTIN-TFTV. ACCESSED : APR 11, 2022.
US NIH-NCI. TIVOZANIB HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. TOCILIZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. TOPOTECAN HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. TOREMIFENE. ACCESSED : APR 11, 2022.
US NIH-NCI. TPF. ACCESSED : APR 11, 2022.
US NIH-NCI. TRABECTEDIN. ACCESSED : APR 11, 2022.
US NIH-NCI. TRAMETINIB DIMETHYL SULFOXIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. TRANSITIONAL CELL CANCER OF THE RENAL PELVIS AND URETER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. TRASTUZUMAB AND HYALURONIDASE-OYSK. ACCESSED : APR 11, 2022.
US NIH-NCI. TRASTUZUMAB. ACCESSED : APR 11, 2022.
US NIH-NCI. TRIFLURIDINE AND TIPIRACIL HYDROCHLORIDE. ACCESSED : APR 11, 2022.
US NIH-NCI. TUCATINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. UMBRALISIB TOSYLATE. ACCESSED : APR 11, 2022.
US NIH-NCI. URETER AND RENAL PELVIS, TRANSITIONAL CELL CANCER (KIDNEY (RENAL CELL) CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. URETHRAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. URETHRAL CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. URIDINE TRIACETATE. ACCESSED : APR 11, 2022.
US NIH-NCI. UTERINE CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. UTERINE SARCOMA TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. VAC. ACCESSED : APR 11, 2022.
US NIH-NCI. VAGINAL CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. VAGINAL CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. VALRUBICIN. ACCESSED : APR 11, 2022.
US NIH-NCI. VAMP. ACCESSED : APR 11, 2022.
US NIH-NCI. VANDETANIB. ACCESSED : APR 11, 2022.
US NIH-NCI. VEIP. ACCESSED : APR 11, 2022.
US NIH-NCI. VEMURAFENIB. ACCESSED : APR 11, 2022.
US NIH-NCI. VENETOCLAX. ACCESSED : APR 11, 2022.
US NIH-NCI. VINBLASTINE SULFATE. ACCESSED : APR 11, 2022.
US NIH-NCI. VINCRISTINE SULFATE LIPOSOME. ACCESSED : APR 11, 2022.
US NIH-NCI. VINORELBINE TARTRATE. ACCESSED : APR 11, 2022.
US NIH-NCI. VIP. ACCESSED : APR 11, 2022.
US NIH-NCI. VISMODEGIB. ACCESSED : APR 11, 2022.
US NIH-NCI. VON HIPPEL-LINDAU DISEASE (PDQ®) - HEALTH PROFESSIONAL VERSION. ACCESSED : JUN 2, 2022.
US NIH-NCI. VORINOSTAT. ACCESSED : APR 11, 2022.
US NIH-NCI. VULVAR CANCER TREATMENT (PDQ®). ACCESSED : APR 8, 2022.
US NIH-NCI. VULVAR CANCER. ACCESSED : APR 6, 2022.
US NIH-NCI. XELIRI. ACCESSED : APR 11, 2022.
US NIH-NCI. XELOX. ACCESSED : APR 11, 2022.
US NIH-NCI. ZANUBRUTINIB. ACCESSED : APR 11, 2022.
US NIH-NCI. ZIV-AFLIBERCEPT. ACCESSED : APR 11, 2022.
US NIH-NCI. ZOLEDRONIC ACID. ACCESSED : APR 11, 2022.
US NIH-NEI. AGE-RELATED MACULAR DEGENERATION. ACCESSED : APR 16, 2022.
US NIH-NEI. AMBLYOPIA (LAZY EYE). ACCESSED : APR 16, 2022.
US NIH-NEI. ANOPHTHALMIA AND MICROPHTHALMIA. ACCESSED : APR 16, 2022.
US NIH-NEI. ASTIGMATISM. ACCESSED : APR 16, 2022.
US NIH-NEI. BEHÇET'S DISEASE. ACCESSED : APR 16, 2022.
US NIH-NEI. BIETTI'S CRYSTALLINE DYSTROPHY. ACCESSED : APR 16, 2022.
US NIH-NEI. BLEPHARITIS. ACCESSED : APR 16, 2022.
US NIH-NEI. BLEPHAROSPASM. ACCESSED : APR 16, 2022.
US NIH-NEI. CATARACTS. ACCESSED : APR 16, 2022.
US NIH-NEI. CEREBRAL VISUAL IMPAIRMENT (CVI). ACCESSED : APR 16, 2022.
US NIH-NEI. COLOBOMA. ACCESSED : APR 16, 2022.
US NIH-NEI. COLOR BLINDNESS. ACCESSED : APR 16, 2022.
US NIH-NEI. CONVERGENCE INSUFFICIENCY. ACCESSED : APR 16, 2022.
US NIH-NEI. CORNEAL CONDITIONS. ACCESSED : APR 16, 2022.
US NIH-NEI. DIABETIC RETINOPATHY. ACCESSED : APR 16, 2022.
US NIH-NEI. DRY EYE. ACCESSED : APR 16, 2022.
US NIH-NEI. FARSIGHTEDNESS (HYPEROPIA). ACCESSED : APR 16, 2022.
US NIH-NEI. FLOATERS. ACCESSED : APR 16, 2022.
US NIH-NEI. GLAUCOMA. ACCESSED : APR 16, 2022.
US NIH-NEI. GRAVES’ EYE DISEASE. ACCESSED : APR 16, 2022.
US NIH-NEI. IDIOPATHIC INTRACRANIAL HYPERTENSION. ACCESSED : APR 16, 2022.
US NIH-NEI. LOW VISION. ACCESSED : APR 16, 2022.
US NIH-NEI. MACULAR EDEMA. ACCESSED : APR 16, 2022.
US NIH-NEI. MACULAR HOLE. ACCESSED : APR 16, 2022.
US NIH-NEI. MACULAR PUCKER. ACCESSED : APR 16, 2022.
US NIH-NEI. NEARSIGHTEDNESS (MYOPIA). ACCESSED : APR 16, 2022.
US NIH-NEI. OCULAR HISTOPLASMOSIS SYNDROME (OHS). ACCESSED : APR 16, 2022.
US NIH-NEI. PINK EYE. ACCESSED : APR 16, 2022.
US NIH-NEI. PRESBYOPIA. ACCESSED : APR 16, 2022.
US NIH-NEI. REFRACTIVE ERRORS. ACCESSED : APR 16, 2022.
US NIH-NEI. RETINAL DETACHMENT. ACCESSED : APR 16, 2022.
US NIH-NEI. RETINITIS PIGMENTOSA. ACCESSED : APR 16, 2022.
US NIH-NEI. RETINOBLASTOMA. ACCESSED : APR 16, 2022.
US NIH-NEI. RETINOPATHY OF PREMATURITY. ACCESSED : APR 16, 2022.
US NIH-NEI. STARGARDT DISEASE. ACCESSED : APR 16, 2022.
US NIH-NEI. USHER SYNDROME. ACCESSED : APR 16, 2022.
US NIH-NEI. UVEITIS. ACCESSED : APR 16, 2022.
US NIH-NEI. VITREOUS DETACHMENT. ACCESSED : APR 16, 2022.|
US NIH-NHLBI. 25 WAYS TO TAKE PART IN HEART MONTH. ACCESSED : APR 18, 2022.
US NIH-NHLBI. ACUTE RESPIRATORY DISTRESS SYNDROME. ACCESSED : APR 5, 2022.
US NIH-NHLBI. ALPHA-1 ANTI-TRYSIN DEFICIENCY. ACCESSED : APR 5, 2022.
US NIH-NHLBI. ANEMIA. ACCESSED : APR 5, 2022.
US NIH-NHLBI. ANGINA. ACCESSED : APR 5, 2022.
US NIH-NHLBI. ANTIPHOSPHOLIPID SYNDROME (APS). ACCESSED : APR 5, 2022.
US NIH-NHLBI. AORTIC ANEURYSM. ACCESSED : APR 5, 2022.
US NIH-NHLBI. APLASTIC ANEMIA. ACCESSED : APR 5, 2022.
US NIH-NHLBI. ARRHYTHMIAS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. ASTHMA. ACCESSED : APR 5, 2022.
US NIH-NHLBI. ATHEROSCLEROSIS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. ATRIAL FIBRILLATION. ACCESSED : APR 5, 2022.
US NIH-NHLBI. BLEEDING DISORDERS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. BLOOD CHOLESTEROL. ACCESSED : APR 5, 2022.
US NIH-NHLBI. BLOOD CLOTTING DISORDERS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. BLOOD TESTS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. BRONCHIECTASIS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. BRONCHITIS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. BRONCHOPULMONARY DYSPLASIA (BPD). ACCESSED : APR 5, 2022.
US NIH-NHLBI. CARDIAC ARREST. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CARDIAC CATHETERIZATION. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CARDIOGENIC SHOCK. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CARDIOMYOPATHY. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CHILDHOOD INTERSTITIAL LUNG DISEASE. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CIRCADIAN RHYTHM DISORDERS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CONDUCTION DISORDERS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CONGENITAL HEART DEFECTS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. COPD. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CORONARY ARTERY BYPASS GRAFTING. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CORONARY HEART DISEASE. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CPAP. ACCESSED : APR 5, 2022.
US NIH-NHLBI. CYSTIC FIBROSIS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. DEFIBRILLATORS. ACCESSED : APR 5, 2022.
US NIH-NHLBI. DISSEMINATED INTRAVASCULAR COAGULATION (DIC). ACCESSED : APR 5, 2022.
US NIH-NHLBI. GENETIC THERAPIES. ACCESSED : APR 6, 2022.
US NIH-NHLBI. HEART ATTACK. ACCESSED : APR 5, 2022.
US NIH-NHLBI. HEART FAILURE. ACCESSED : APR 5, 2022.
US NIH-NHLBI. HEART INFLAMMATION. ACCESSED : APR 5, 2022.
US NIH-NHLBI. HEART SURGERY. ACCESSED : APR 5, 2022.
US NIH-NHLBI. HEART VALVE DISEASES. ACCESSED : APR 5, 2022.
US NIH-NHLBI. HEART-HEALTHY LIVING. ACCESSED : APR 5, 2022.
US NIH-NHLBI. HEMOLYTIC ANEMIA. ACCESSED : APR 5, 2022.
US NIH-NHLBI. HIGH BLOOD PRESSURE. ACCESSED : APR 6, 2022.
US NIH-NHLBI. HIGH BLOOD TRIGLYCERIDES. ACCESSED : APR 6, 2022.
US NIH-NHLBI. HOW CLINICAL TRIALS WORK. ACCESSED : APR 5, 2022.
US NIH-NHLBI. HOW SLEEP WORKS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. HYPERSENSITIVITY PNEUMONITIS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. IDIOPATHIC PULMONARY FIBROSIS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. IMMUNE THROMBOYCTOPENIA (ITP). ACCESSED : APR 6, 2022.
US NIH-NHLBI. INSOMNIA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. INTERSTITIAL LUNG DISEASES. ACCESSED : APR 5, 2022.
US NIH-NHLBI. IRON DEFICIENCY ANEMIA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. LONG QT SYNDROME. ACCESSED : APR 6, 2022.
US NIH-NHLBI. LOW BLOOD PRESSURE. ACCESSED : APR 6, 2022.
US NIH-NHLBI. LYMPHANGIOLEIOMYOMATOSIS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. LYMPHOPENIA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. MARFAN SYNDROME. ACCESSED : APR 6, 2022.
US NIH-NHLBI. METABOLIC SYNDROME. ACCESSED : APR 6, 2022.
US NIH-NHLBI. NARCOLEPSY. ACCESSED : APR 6, 2022.
US NIH-NHLBI. OBESITY HYPOVENTILATION SYNDROME. ACCESSED : APR 6, 2022.
US NIH-NHLBI. OVERWEIGHT AND OBESITY. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PACEMAKERS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PERIPHERAL ARTERY DISEASE. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PHYSICAL ACTIVITY AND YOUR HEART. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PLATELET DISORDERS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PLEURAL DISORDERS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PNEUMONIA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PRIMARY CILIARY DYSKINESIA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PULMONARY HYPERTENSION. ACCESSED : APR 6, 2022.
US NIH-NHLBI. PULMONARY REHABILITATION. ACCESSED : APR 6, 2022.
US NIH-NHLBI. RESPIRATORY FAILURE. ACCESSED : APR 6, 2022.
US NIH-NHLBI. SARCOIDOSIS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. SICKLE CELL DISEASE. ACCESSED : APR 6, 2022.
US NIH-NHLBI. SLEEP APNEA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. SLEEP DEPRIVATION AND DEFICIENCY. ACCESSED : APR 6, 2022.
US NIH-NHLBI. SLEEP STUDY. ACCESSED : APR 6, 2022.
US NIH-NHLBI. STROKE. ACCESSED : APR 6, 2022.
US NIH-NHLBI. THALASSEMIAS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. THE HEART. ACCESSED : APR 6, 2022.
US NIH-NHLBI. THE LUNG. ACCESSED : APR 6, 2022.
US NIH-NHLBI. THROMBOCYTHEMIA AND THROMBOCYTOSIS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. THROMBOCYTOPENIA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. THROMBOTIC THROMBOCYTOPENIC PURPURA (TTP). ACCESSED : APR 6, 2022.
US NIH-NHLBI. TOTAL ARTIFICIAL HEART. ACCESSED : APR 6, 2022.
US NIH-NHLBI. TRANSCATHETER AORTIC VALVE REPLACEMENT. ACCESSED : APR 6, 2022.
US NIH-NHLBI. VARICOSE VEINS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. VASCULAR DEMENTIA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. VASCULITIS. ACCESSED : APR 6, 2022.
US NIH-NHLBI. VENOUS THROMBOEMBOLISM. ACCESSED : APR 6, 2022.
US NIH-NHLBI. VENTILATOR/VENTILATOR SUPPORT. ACCESSED : APR 6, 2022.
US NIH-NHLBI. VITAMIN B12 DEFICIENCY ANEMIA. ACCESSED : APR 6, 2022.
US NIH-NHLBI. WOLFF-PARKINSON-WHITE SYNDROME. ACCESSED : APR 6, 2022.
US NIH-NIAID. ECZEMA (ATOPIC DERMATITIS). ACCESSED : APR 15, 2022.
US NIH-NIAID. LYME DISEASE. ACCESSED : APR 15, 2022.
US NIH-NIAMS. ACNE. ACCESSED : APR 18, 2022.
US NIH-NIAMS. ALOPECIA AREATA. ACCESSED : APR 18, 2022.
US NIH-NIAMS. ANKYLOSING SPONDYLITIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. ARTHRITIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. ATOPIC DERMATITIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. AUTOIMMUNE DISEASES. ACCESSED : APR 18, 2022.
US NIH-NIAMS. AUTOINFLAMMATORY DISEASES. ACCESSED : APR 18, 2022.
US NIH-NIAMS. BACK PAIN. ACCESSED : APR 18, 2022.
US NIH-NIAMS. BEHÇET’S DISEASE. ACCESSED : APR 18, 2022.
US NIH-NIAMS. EPIDERMOLYSIS BULLOSA. ACCESSED : APR 18, 2022.
US NIH-NIAMS. FIBROMYALGIA. ACCESSED : APR 18, 2022.
US NIH-NIAMS. FIBROUS DYSPLASIA. ACCESSED : APR 18, 2022.
US NIH-NIAMS. GOUT. ACCESSED : APR 18, 2022.
US NIH-NIAMS. GROWTH PLATE INJURIES. ACCESSED : APR 18, 2022.
US NIH-NIAMS. HIDRADENITIS SUPPURATIVA (HS). ACCESSED : APR 18, 2022.
US NIH-NIAMS. HIP REPLACEMENT SURGERY. ACCESSED : APR 18, 2022.
US NIH-NIAMS. ICHTHYOSIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. JUVENILE ARTHRITIS. ACCESSED : APR 15, 2022.
US NIH-NIAMS. MARFAN SYNDROME. ACCESSED : APR 18, 2022.
US NIH-NIAMS. OSTEOARTHRITIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. OSTEOGENESIS IMPERFECTA. ACCESSED : APR 18, 2022.
US NIH-NIAMS. OSTEONECROSIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. OSTEOPETROSIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. OSTEOPOROSIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. PACHYONYCHIA CONGENITA. ACCESSED : APR 18, 2022.
US NIH-NIAMS. PAGET’S DISEASE OF BONE. ACCESSED : APR 18, 2022.
US NIH-NIAMS. PEMPHIGUS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. POLYMYALGIA RHEUMATICA AND GIANT CELL ARTERITIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. PSORIASIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. PSORIATIC ARTHRITIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. RAYNAUD’S PHENOMENON. ACCESSED : APR 18, 2022.
US NIH-NIAMS. REACTIVE ARTHRITIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. RHEUMATOID ARTHRITIS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. ROSACEA. ACCESSED : APR 18, 2022.
US NIH-NIAMS. SCLERODERMA. ACCESSED : APR 18, 2022.
US NIH-NIAMS. SCOLIOSIS IN CHILDREN AND TEENS. ACCESSED : APR 18, 2022.
US NIH-NIAMS. SJÖGREN’S SYNDROME. ACCESSED : APR 18, 2022.
US NIH-NIAMS. SPINAL STENOSIS. ACCESSED : APR 18, 2022.|
US NIH-NIAMS. SPORTS INJURIES. ACCESSED : APR 18, 2022.
US NIH-NIAMS. SYSTEMIC LUPUS ERYTHEMATOSUS (LUPUS). ACCESSED : APR 18, 2022.
US NIH-NIAMS. VITILIGO. ACCESSED : APR 18, 2022.
US NIH-NICHD. ADRENAL GLAND DISORDERS. ACCESSED : APR 15, 2022.
US NIH-NICHD. AIDS/HIV. ACCESSED : APR 15, 2022.
US NIH-NICHD. AMENORRHEA. ACCESSED : APR 15, 2022.
US NIH-NICHD. AUTISM SPECTRUM DISORDER (ASD). ACCESSED : APR 15, 2022.
US NIH-NICHD. BACTERIAL VAGINOSIS. ACCESSED : APR 15, 2022.
US NIH-NICHD. BIRTH DEFECTS. ACCESSED : APR 15, 2022.
US NIH-NICHD. BREASTFEEDING AND BREAST MILK. ACCESSED : APR 15, 2022.
US NIH-NICHD. BULLYING. ACCESSED : APR 15, 2022.
US NIH-NICHD. CEREBRAL PALSY. ACCESSED : APR 15, 2022.
US NIH-NICHD. CONGENITAL ADRENAL HYPERPLASIA (CAH). ACCESSED : APR 15, 2022.
US NIH-NICHD. CONTRACEPTION AND BIRTH CONTROL. ACCESSED : APR 15, 2022.
US NIH-NICHD. CUSHING SYNDROME. ACCESSED : APR 15, 2022.
US NIH-NICHD. DIABETES. ACCESSED : APR 15, 2022.
US NIH-NICHD. DOWN SYNDROME. ACCESSED : APR 15, 2022.
US NIH-NICHD. EARLY LEARNING. ACCESSED : APR 15, 2022.
US NIH-NICHD. ENDOMETRIOSIS. ACCESSED : APR 15, 2022.
US NIH-NICHD. FRAGILE X SYNDROME. ACCESSED : APR 15, 2022.
US NIH-NICHD. FRAGILE X-ASSOCIATED PRIMARY OVARIAN INSUFFICIENCY (FXPOI). ACCESSED : APR 15, 2022.
US NIH-NICHD. FRAGILE X-ASSOCIATED TREMOR AND ATAXIA SYNDROME (FXTAS). ACCESSED : APR 15, 2022.
US NIH-NICHD. HIGH-RISK PREGNANCY. ACCESSED : APR 15, 2022.
US NIH-NICHD. HYPOPARATHYROIDISM. ACCESSED : APR 15, 2022.
US NIH-NICHD. INFANT CARE AND INFANT HEALTH. ACCESSED : APR 15, 2022.
US NIH-NICHD. INFANT MORTALITY. ACCESSED : APR 15, 2022.
US NIH-NICHD. INFERTILITY AND FERTILITY. ACCESSED : APR 15, 2022.
US NIH-NICHD. INTELLECTUAL AND DEVELOPMENTAL DISABILITIES (IDDS). ACCESSED : APR 15, 2022.
US NIH-NICHD. KLINEFELTER SYNDROME (KS). ACCESSED : APR 15, 2022.
US NIH-NICHD. LABOR AND DELIVERY. ACCESSED : APR 15, 2022.
US NIH-NICHD. LEARNING DISABILITIES. ACCESSED : APR 15, 2022.
US NIH-NICHD. MATERNAL MORBIDITY AND MORTALITY. ACCESSED : APR 15, 2022.
US NIH-NICHD. MCCUNE-ALBRIGHT SYNDROME (MAS). ACCESSED : APR 15, 2022.
US NIH-NICHD. MEN'S REPRODUCTIVE HEALTH. ACCESSED : APR 15, 2022.
US NIH-NICHD. MENOPAUSE. ACCESSED : APR 15, 2022.
US NIH-NICHD. MENSTRUATION AND MENSTRUAL PROBLEMS. ACCESSED : APR 15, 2022.
US NIH-NICHD. MUSCULAR DYSTROPHY. ACCESSED : APR 15, 2022.
US NIH-NICHD. NECROTIZING ENTEROCOLITIS (NEC). ACCESSED : APR 15, 2022.
US NIH-NICHD. NEURAL TUBE DEFECTS (NTDS). ACCESSED : APR 15, 2022.
US NIH-NICHD. NEUROSCIENCE. ACCESSED : APR 15, 2022.
US NIH-NICHD. NEWBORN SCREENING. ACCESSED : APR 15, 2022.
US NIH-NICHD. OBESITY AND OVERWEIGHT. ACCESSED : APR 15, 2022.
US NIH-NICHD. OSTEOGENESIS IMPERFECTA (OI). ACCESSED : APR 15, 2022.
US NIH-NICHD. PEDIATRIC INJURY. ACCESSED : APR 15, 2022.
US NIH-NICHD. PELVIC FLOOR DISORDERS (PFDS). ACCESSED : APR 15, 2022.
US NIH-NICHD. PELVIC PAIN. ACCESSED : APR 15, 2022.
US NIH-NICHD. PHENYLKETONURIA (PKU). ACCESSED : APR 15, 2022.
US NIH-NICHD. PITUITARY TUMORS. ACCESSED : APR 15, 2022.
US NIH-NICHD. POLYCYSTIC OVARY SYNDROME (PCOS). ACCESSED : APR 15, 2022.
US NIH-NICHD. PRADER-WILLI SYNDROME (PWS). ACCESSED : APR 15, 2022.
US NIH-NICHD. PRE-PREGNANCY CARE AND PRENATAL CARE. ACCESSED : APR 15, 2022.
US NIH-NICHD. PREECLAMPSIA AND ECLAMPSIA. ACCESSED : APR 15, 2022.
US NIH-NICHD. PREGNANCY LOSS (BEFORE 20 WEEKS OF PREGNANCY). ACCESSED : APR 15, 2022.
US NIH-NICHD. PREGNANCY. ACCESSED : APR 15, 2022.
US NIH-NICHD. PRETERM LABOR AND BIRTH. ACCESSED : APR 15, 2022.
US NIH-NICHD. PRIMARY OVARIAN INSUFFICIENCY (POI). ACCESSED : APR 15, 2022.
US NIH-NICHD. PUBERTY AND PRECOCIOUS PUBERTY. ACCESSED : APR 15, 2022.
US NIH-NICHD. READING AND READING DISORDERS. ACCESSED : APR 15, 2022.
US NIH-NICHD. REHABILITATION MEDICINE. ACCESSED : APR 15, 2022.
US NIH-NICHD. REHABILITATIVE AND ASSISTIVE TECHNOLOGY. ACCESSED : APR 15, 2022.
US NIH-NICHD. RETT SYNDROME. ACCESSED : APR 15, 2022.
US NIH-NICHD. SEXUALLY TRANSMITTED DISEASES (STDS). ACCESSED : APR 15, 2022.
US NIH-NICHD. SLEEP. ACCESSED : APR 15, 2022.
US NIH-NICHD. SPINA BIFIDA. ACCESSED : APR 15, 2022.
US NIH-NICHD. SPINAL CORD INJURY (SCI). ACCESSED : APR 15, 2022.
US NIH-NICHD. STROKE. ACCESSED : APR 15, 2022.
US NIH-NICHD. SUDDEN INFANT DEATH SYNDROME (SIDS). ACCESSED : APR 15, 2022.
US NIH-NICHD. TRAUMATIC BRAIN INJURY (TBI). ACCESSED : APR 15, 2022.
US NIH-NICHD. TURNER SYNDROME. ACCESSED : APR 15, 2022.
US NIH-NICHD. URINARY TRACT HEALTH. ACCESSED : APR 15, 2022.
US NIH-NICHD. UTERINE FIBROIDS. ACCESSED : APR 15, 2022.
US NIH-NICHD. VAGINITIS. ACCESSED : APR 15, 2022.
US NIH-NICHD. VASECTOMY. ACCESSED : APR 15, 2022.
US NIH-NICHD. VULVODYNIA. ACCESSED : APR 15, 2022.
US NIH-NICHD. ZIKA. ACCESSED : APR 15, 2022.|
US NIH-NIDA. INHALANTS RESEARCH REPORT. WHAT ARE THE OTHER MEDICAL CONSEQUENCES OF INHALANT ABUSE? ACCESSED : MAY 9, 2022.
US NIH-NIDCR. CHILDREN’S ORAL HEALTH. ACCESSED : APR 15, 2022.
US NIH-NIDCR. TRIGEMINAL NEURALGIA. ACCESSED : JUL 18, 2022.
US NIH-NIDOCD. EAR INFECTIONS IN CHILDREN. ACCESSED : APR 15, 2022.
US NIH-NIMH. ANXIETY DISORDERS. ACCESSED : MAY 10, 2022.
US NIH-NIMH. ATTENTION DEFICIT/HYPERACTIVITY DISORDER. ACCESSED : MAY 10, 2022.
US NIH-NIMH. AUTISM SPECTRUM DISORDER (ASD). ACCESSED : MAY 10, 2022.
US NIH-NIMH. BIPOLAR DISORDER. ACCESSED : MAY 10, 2022.
US NIH-NIMH. BORDERLINE PERSONALITY DISORDER. ACCESSED : MAY 10, 2022.
US NIH-NIMH. BRAIN STIMULATION THERAPIES. ACCESSED : MAY 10, 2022.
US NIH-NIMH. DEPRESSION. ACCESSED : MAY 10, 2022.
US NIH-NIMH. DISRUPTIVE MOOD DYSREGULATION DISORDER. ACCESSED : MAY 10, 2022.
US NIH-NIMH. EATING DISORDERS. (STATISTICS). ACCESSED : JUN 3, 2022.
US NIH-NIMH. EATING DISORDERS. ACCESSED : MAY 10, 2022.
US NIH-NIMH. HIV/AIDS AND MENTAL HEALTH. ACCESSED : MAY 10, 2022.
US NIH-NIMH. OBSESSIVE-COMPULSIVE DISORDER (OCD). ACCESSED : MAY 10, 2022.
US NIH-NIMH. POST-TRAUMATIC STRESS DISORDER (PTSD). ACCESSED : MAY 10, 2022.
US NIH-NIMH. PSYCHOTHERAPIES. ACCESSED : MAY 10, 2022.
US NIH-NIMH. SCHIZOPHRENIA. ACCESSED : MAY 10, 2022.
US NIH-NIMH. SUBSTANCE USE AND CO-OCCURRING MENTAL DISORDERS. ACCESSED : MAY 10, 2022.
US NIH-NIMH. SUICIDE PREVENTION. ACCESSED : MAY 10, 2022.
US NIH-NIMH. TRAUMATIC EVENTS. ACCESSED : MAY 10, 2022.|
US NIH-NINDS. SHAKEN BABY SYNDROME. ACCESSED : APR 15, 2022.
US NIH-NINDS. SPINAL MUSCULAR ATROPHY. ACCESSED : APR 15, 2022.
US NIH-NLM. AMAUROSIS FUGAX. MEDLINEPLUS. ACCESSED : JUL 18, 2022.
US NIH-NLM. ATRIAL MYXOMA. MEDLINEPLUS. ACCESSED : JUL 18, 2022.
US NIH-NLM. MEDLINE PLUS. CARNEY COMPLEX. ACCESSED : APR 15, 2022.
US NIH-NLM. MEDLINEPLUS. 22Q13.3 DELETION SYNDROME. ACCESSED : NOV 13, 2021.
US NIH-NLM. MEDLINEPLUS. NIEMANN-PICK DISEASE. ACCESSED : APR 15, 2022.
US NIH-NLM. MEDLINEPLUS. TK2-RELATED MITOCHONDRIAL DNA DEPLETION SYNDROME, MYOPATHIC FORM. ACCESSED : NOV 10, 2021.
US NIH-NLM. SEXUALLY TRANSMITTED DISEASES. MEDLINEPLUS. ACCESSED : MAY 24, 2022.
US NIH. HEREDITARY LEIOMYOMATOSIS AND RENAL CELL CANCER (PDQ®) - HEALTH PROFESSIONAL VERSION. ACCESSED : JUN 2, 2022.
US NIH. LIST OF REGISTRIES. ACCESSED : OCT 7, 2022.
US. FDA. GUIDANCE. NECESSITY OF THE USE OF FOOD PRODUCT CATEGORIES IN FOOD FACILITY REGISTRATIONS AND UPDATES TO FOOD PRODUCT CATEGORIES (2016 EDITION). SEP 2016.
US. PUBLIC LAW 117-79. ACCELERATING ACCESS TO CRITICAL THERAPIES FOR ALS ACT. DEC 23, 2021.
WHO-UMC. DRUG INDUCED LIVER INJURY (DILI). ACCESSED : JUN 14, 2022.
WHO. ABORTION. ACCESSED : JUN 14, 2022.
WHO. ADDICTIVE BEHAVIOUR. ACCESSED : JUN 14, 2022.
WHO. ADOLESCENT HEALTH. ACCESSED : JUN 14, 2022.
WHO. AGEING. ACCESSED : JUN 14, 2022.
WHO. AGEISM. ACCESSED : JUN 14, 2022.
WHO. AIR POLLUTION. ACCESSED : JUN 14, 2022.
WHO. ALCOHOL. ACCESSED : JUN 14, 2022.
WHO. ANAEMIA. ACCESSED : JUN 14, 2022.
WHO. ANTIMICROBIAL RESISTANCE. ACCESSED : JUN 14, 2022.
WHO. ASSISTIVE DEVICES. ACCESSED : JUN 14, 2022.
WHO. BIOLOGICAL WEAPONS. ACCESSED : JUN 14, 2022.
WHO. BIOLOGICALS. ACCESSED : JUN 14, 2022.
WHO. BLOOD PRODUCTS. ACCESSED : JUN 14, 2022.
WHO. BLOOD TRANSFUSION SAFETY. ACCESSED : JUN 14, 2022.
WHO. BRAIN HEALTH. ACCESSED : JUN 15, 2022.
WHO. BREASTFEEDING. ACCESSED : JUN 15, 2022.
WHO. BURULI ULCER (MYCOBACTERIUM ULCERANS INFECTION). ACCESSED : JUN 15, 2022.
WHO. CANCER. ACCESSED : JUN 15, 2022.
WHO. CARDIOVASCULAR DISEASES. ACCESSED : JUN 15, 2022.
WHO. CERVICAL CANCER. ACCESSED : JUN 15, 2022.
WHO. CHAGAS DISEASE (AMERICAN TRYPANOSOMIASIS). ACCESSED : JUN 15, 2022.
WHO. CHEMICAL INCIDENTS. ACCESSED : JUN 15, 2022.
WHO. CHIKUNGUNYA. ACCESSED : JUN 15, 2022.
WHO. CHILD GROWTH. ACCESSED : JUN 15, 2022.
WHO. CHILD HEALTH. ACCESSED : JUN 15, 2022.
WHO. CHILDREN’S ENVIRONMENTAL HEALTH. ACCESSED : JUN 15, 2022.
WHO. CHOLERA. ACCESSED : JUN 15, 2022.
WHO. CHRONIC RESPIRATORY DISEASES. ACCESSED : JUN 15, 2022.
WHO. CLIMATE CHANGE. ACCESSED : JUN 15, 2022.
WHO. COMMERCIAL DETERMINANTS OF HEALTH. ACCESSED : JUN 15, 2022.
WHO. COMMON GOODS FOR HEALTH. ACCESSED : JUN 15, 2022.
WHO. COMPLEMENTARY FEEDING. ACCESSED : JUN 16, 2022.
WHO. CONGENITAL ANOMALIES. ACCESSED : JUN 16, 2022.
WHO. CONTRACEPTION. ACCESSED : JUN 16, 2022.
WHO. CORONAVIRUS DISEASE (COVID-19). ACCESSED : JUN 16, 2022.
WHO. CRIMEAN-CONGO HAEMORRHAGIC FEVER. ACCESSED : JUN 16, 2022.
WHO. DEAFNESS AND HEARING LOSS. ACCESSED : JUN 16, 2022.
WHO. DELIBERATE EVENTS. ACCESSED : JUN 16, 2022.
WHO. DEMENTIA. ACCESSED : JUN 16, 2022.
WHO. DENGUE AND SEVERE DENGUE. ACCESSED : JUN 16, 2022.
WHO. DEPRESSION. ACCESSED : JUN 16, 2022.
WHO. DIABETES. ACCESSED : JUN 16, 2022.
WHO. DIARRHOEA. ACCESSED : JUN 16, 2022.
WHO. DIGITAL HEALTH. ACCESSED : JUN 16, 2022.
WHO. DISABILITY. ACCESSED : JUN 16, 2022.
WHO. DRACUNCULIASIS (GUINEA-WORM DISEASE). ACCESSED : JUN 16, 2022.
WHO. DROUGHT. ACCESSED : JUN 16, 2022.
WHO. DROWNING. ACCESSED : JUN 16, 2022.
WHO. DRUGS (PSYCHOACTIVE). ACCESSED : JUN 16, 2022.
WHO. EARTHQUAKES. ACCESSED : JUN 16, 2022.
WHO. EBOLA VIRUS DISEASE. ACCESSED : JUN 16, 2022.
WHO. ECHINOCOCCOSIS. ACCESSED : JUN 16, 2022.
WHO. ELECTROMAGNETIC FIELDS. ACCESSED : JUN 16, 2022.
WHO. EMERGENCY CARE. ACCESSED : JUN 16, 2022.
WHO. ENERGY AND HEALTH. ACCESSED : JUN 16, 2022.
WHO. ENVIRONMENTAL HEALTH. ACCESSED : JUN 16, 2022.
WHO. EPILEPSY. ACCESSED : JUN 16, 2022.
WHO. EYE CARE VISION IMPAIRMENT AND BLINDNESS. ACCESSED : JUN 16, 2022.
WHO. FEMALE GENITAL MUTILATION. ACCESSED : JUN 16, 2022.
WHO. FINANCIAL PROTECTION. ACCESSED : JUN 16, 2022.
WHO. FLOODS. ACCESSED : JUN 16, 2022.
WHO. FOOD FORTIFICATION. ACCESSED : JUN 16, 2022.
WHO. FOOD SAFETY. ACCESSED : JUN 16, 2022.
WHO. FOODBORNE DISEASES. ACCESSED : JUN 16, 2022.
WHO. FOODBORNE TREMATODE INFECTIONS. ACCESSED : JUN 16, 2022.
WHO. GENETICALLY MODIFIED FOODS. ACCESSED : JUN 16, 2022.
WHO. GLOBAL HEALTH ETHICS. ACCESSED : JUN 17, 2022.
WHO. HEALTH ACCOUNTS. ACCESSED : JUN 17, 2022.
WHO. HEALTH BUDGET. ACCESSED : JUN 17, 2022.
WHO. HEALTH ECONOMICS. ACCESSED : JUN 17, 2022.
WHO. HEALTH EQUITY. ACCESSED : JUN 17, 2022.
WHO. HEALTH FINANCING. ACCESSED : JUN 17, 2022.
WHO. HEALTH IMPACT ASSESSMENT. ACCESSED : JUN 17, 2022.
WHO. HEALTH PROMOTION. ACCESSED : JUN 17, 2022.
WHO. HEALTH TAXES. ACCESSED : JUN 17, 2022.
WHO. HEALTH TECHNOLOGY ASSESSMENT. ACCESSED : JUN 17, 2022.
WHO. HEALTH WORKFORCE. ACCESSED : JUN 17, 2022.
WHO. HEALTHY DIET. ACCESSED : JUN 17, 2022.
WHO. HEATWAVE. ACCESSED : JUN 17, 2022.
WHO. HEPATITIS. ACCESSED : JUN 17, 2022.
WHO. HIV/AIDS. ACCESSED : JUN 17, 2022.
WHO. HOSPITAL. ACCESSED : JUN 17, 2022.
WHO. HOW TO SET UP A DRUG UTILIZATION STUDY. ACCESSED : MAY 26, 2022.
WHO. HUMAN AFRICAN TRYPANOSOMIASIS (SLEEPING SICKNESS). ACCESSED : JUN 17, 2022.
WHO. HUMAN GENOME EDITING. ACCESSED : JUN 17, 2022.
WHO. HUMAN RIGHTS. ACCESSED : JUN 17, 2022.
WHO. HYPERTENSION. ACCESSED : JUN 17, 2022.
WHO. IN VITRO DIAGNOSTICS. ACCESSED : JUN 17, 2022.
WHO. INFANT NUTRITION. ACCESSED : JUN 17, 2022.
WHO. INFECTION PREVENTION AND CONTROL. ACCESSED : JUN 17, 2022.
WHO. INFERTILITY. ACCESSED : JUN 17, 2022.
WHO. INFLUENZA (AVIAN AND OTHER ZOONOTIC). ACCESSED : JUN 17, 2022.
WHO. INFLUENZA SEASONAL. ACCESSED : JUN 17, 2022.
WHO. INFODEMIC. ACCESSED : JUN 17, 2022.
WHO. INTELLECTUAL PROPERTY. ACCESSED : JUN 17, 2022.
WHO. INTERNATIONAL HEALTH REGULATIONS. ACCESSED : JUN 17, 2022.
WHO. LANDSLIDES. ACCESSED : JUN 13, 2022.
WHO. LASSA FEVER. ACCESSED : JUN 13, 2022.
WHO. LEISHMANIASIS. ACCESSED : JUN 18, 2022.
WHO. LEPROSY (HANSEN’S DISEASE). ACCESSED : JUN 18, 2022.
WHO. LYMPHATIC FILARIASIS (ELEPHANTIASIS). ACCESSED : JUN 18, 2022.
WHO. MALARIA. ACCESSED : JUN 18, 2022.
WHO. MALNUTRITION. ACCESSED : JUN 18, 2022.
WHO. MARBURG VIRUS DISEASE. ACCESSED : JUN 18, 2022.
WHO. MATERNAL HEALTH. ACCESSED : JUN 18, 2022.
WHO. MEASLES. ACCESSED : JUN 18, 2022.
WHO. MEDICAL DEVICES. ACCESSED : JUN 18, 2022.
WHO. MEDICINES. ACCESSED : JUN 18, 2022.
WHO. MENINGITIS. ACCESSED : JUN 18, 2022.
WHO. MENTAL HEALTH. ACCESSED : JUN 18, 2022.
WHO. MICRONUTRIENTS. ACCESSED : JUN 18, 2022.
WHO. MIDDLE EAST RESPIRATORY SYNDROME CORONAVIRUS (MERS-COV). ACCESSED : JUN 18, 2022.
WHO. MONKEYPOX. ACCESSED : JUN 18, 2022.
WHO. MYCETOMA, CHROMOBLASTOMYCOSIS AND OTHER DEEP MYCOSES. ACCESSED : JUN 18, 2022.
WHO. MYCOTOXINS. MAY 9, 2018.
WHO. NEGLECTED TROPICAL DISEASES. ACCESSED : JUN 18, 2022.
WHO. NEWBORN HEALTH. ACCESSED : JUN 18, 2022.
WHO. NIPAH VIRUS INFECTION. ACCESSED : JUN 18, 2022.
WHO. NURSING AND MIDWIFERY. ACCESSED : JUN 18, 2022.
WHO. OBESITY. ACCESSED : JUN 18, 2022.
WHO. OCCUPATIONAL HEALTH. ACCESSED : JUN 18, 2022.
WHO. ONCHOCERCIASIS (RIVER BLINDNESS). ACCESSED : JUN 18, 2022.
WHO. ORAL HEALTH. ACCESSED : JUN 18, 2022.
WHO. OXYGEN. ACCESSED : JUN 18, 2022.
WHO. PALLIATIVE CARE. ACCESSED : JUN 18, 2022.
WHO. PATIENT SAFETY. ACCESSED : JUN 18, 2022.
WHO. PERTUSSIS. ACCESSED : JUN 18, 2022.
WHO. PHYSICAL ACTIVITY. ACCESSED : JUN 18, 2022.
WHO. PLAGUE. ACCESSED : JUN 18, 2022.
WHO. PNEUMONIA. ACCESSED : JUN 18, 2022.
WHO. POLIOMYELITIS (POLIO). ACCESSED : JUN 18, 2022.
WHO. PRIMARY HEALTH CARE. ACCESSED : JUN 20, 2022.
WHO. QUALITY OF CARE. ACCESSED : JUN 20, 2022.
WHO. RABIES. ACCESSED : JUN 20, 2022.
WHO. RADIATION EMERGENCIES. ACCESSED : JUN 20, 2022.
WHO. RADIATION. ACCESSED : JUN 20, 2022.
WHO. RADON. ACCESSED : JUN 20, 2022.
WHO. REFUGEE AND MIGRANT HEALTH. ACCESSED : JUN 20, 2022.
WHO. REHABILITATION. ACCESSED : JUN 20, 2022.
WHO. RHEUMATIC HEART DISEASE. ACCESSED : JUN 20, 2022.
WHO. RIFT VALLEY FEVER. ACCESSED : JUN 20, 2022.
WHO. ROAD TRAFFIC INJURIES. ACCESSED : JUN 20, 2022.
WHO. SCHISTOSOMIASIS (BILHARZIA). ACCESSED : JUN 20, 2022.
WHO. SELF-CARE INTERVENTIONS FOR HEALTH. ACCESSED : JUN 20, 2022.
WHO. SEPSIS. ACCESSED : JUN 20, 2022.
WHO. SEVERE ACUTE RESPIRATORY SYNDROME (SARS). ACCESSED : JUN 20, 2022.
WHO. SEXUAL HEALTH. ACCESSED : JUN 20, 2022.
WHO. SEXUALLY TRANSMITTED INFECTIONS (STIS). ACCESSED : JUN 20, 2022.
WHO. SMALLPOX. ACCESSED : JUN 20, 2022.
WHO. SNAKEBITE ENVENOMING. ACCESSED : JUN 20, 2022.
WHO. SOCIAL DETERMINANTS OF HEALTH. ACCESSED : JUN 20, 2022.
WHO. SOIL-TRANSMITTED HELMINTHIASES. ACCESSED : JUN 20, 2022.
WHO. STILLBIRTH. ACCESSED : JUN 20, 2022.
WHO. SUBSTANDARD AND FALSIFIED MEDICAL PRODUCTS. ACCESSED : JUN 20, 2022.
WHO. SUICIDE. ACCESSED : JUN 20, 2022.
WHO. SUSTAINABLE DEVELOPMENT. ACCESSED : JUN 20, 2022.
WHO. SYPHILIS. ACCESSED : JUN 20, 2022.
WHO. TAENIASIS AND CYSTICERCOSIS. ACCESSED : JUN 20, 2022.
WHO. TETANUS. ACCESSED : JUN 20, 2022.
WHO. TICK-BORNE ENCEPHALITIS. ACCESSED : JUN 20, 2022.
WHO. TOBACCO. ACCESSED : JUN 20, 2022.
WHO. TRACHOMA. ACCESSED : JUN 20, 2022.
WHO. TRADITIONAL, COMPLEMENTARY, AND INTEGRATIVE MEDICINE. ACCESSED : JUN 20, 2022.
WHO. TRANSPLANTATION. ACCESSED : JUN 20, 2022.
WHO. TRAVEL AND HEALTH. ACCESSED : JUN 20, 2022.
WHO. TROPICAL CYCLONES. ACCESSED : JUN 20, 2022.
WHO. TSUNAMIS. ACCESSED : JUN 20, 2022.
WHO. TUBERCULOSIS. ACCESSED : JUN 20, 2022.
WHO. TYPHOID. ACCESSED : JUN 20, 2022.
WHO. ULTRAVIOLET RADIATION. ACCESSED : JUN 20, 2022.
WHO. UNIVERSAL HEALTH COVERAGE. ACCESSED : JUN 20, 2022.
WHO. URBAN HEALTH. ACCESSED : JUN 20, 2022.
WHO. VACCINES AND IMMUNIZATION. ACCESSED : JUN 20, 2022.
WHO. VIOLENCE AGAINST CHILDREN. ACCESSED : JUN 20, 2022.
WHO. VIOLENCE AGAINST WOMEN. ACCESSED : JUN 20, 2022.
WHO. VITAMIN A DEFICIENCY. ACCESSED : JUN 14, 2022.
WHO. VOLCANIC ERUPTIONS. ACCESSED : JUN 20, 2022.
WHO. WATER, SANITATION AND HYGIENE (WASH). ACCESSED : JUN 20, 2022.
WHO. WHO PROGRAMME FOR INTERNATIONAL DRUG MONITORING. ACCESSED : JUN 13, 2022.
WHO. WILDFIRES. ACCESSED : JUN 20, 2022.
WHO. YAWS (ENDEMIC TREPONEMATOSES). ACCESSED : JUN 20, 2022.
WHO. YELLOW FEVER. ACCESSED : JUN 20, 2022.
WHO. ZIKA VIRUS DISEASE. ACCESSED : JUN 20, 2022.
WIKIIPEDIA. LANGERHANS CELL HISTIOCYTOSIS.
WIKIPEDIA. 22Q13 DELETION SYNDROME.
WIKIPEDIA. 714-X.
WIKIPEDIA. ABACAVIR.
WIKIPEDIA. ABSENCE SEIZURE.
WIKIPEDIA. ACTAEA RACEMOSA.
WIKIPEDIA. ACUPUNCTURE.
WIKIPEDIA. ACUTE CORONARY SYNDROME.
WIKIPEDIA. ACUTE LYMPHOBLASTIC LEUKEMIA.
WIKIPEDIA. ADRENOCORTICAL CARCINOMA.
WIKIPEDIA. ADRENOLEUKODYSTROPHY.
WIKIPEDIA. ADVANCED SLEEP PHASE DISORDER.
WIKIPEDIA. AGAINST MEDICAL ADVICE.
WIKIPEDIA. AGRANULOCYTOSIS.
WIKIPEDIA. ALTITUDE SICKNESS.
WIKIPEDIA. AMELIA (BIRTH DEFECT).
WIKIPEDIA. AMYLOIDOSIS.
WIKIPEDIA. ANAPLASTIC ASTROCYTOMA.
WIKIPEDIA. ANXIETY DISORDER.
WIKIPEDIA. APHONIA.
WIKIPEDIA. APROTININ.
WIKIPEDIA. AROMATHERAPY.
WIKIPEDIA. ARTIFICIAL HEART.
WIKIPEDIA. ASTEMIZOLE.
WIKIPEDIA. ATRIOVENTRICULAR BLOCK. ACCESSED : OCT 13, 2021.
WIKIPEDIA. ATYPICAL TERATOID RHABDOID TUMOR.
WIKIPEDIA. AUTOIMMUNE DISEASE.
WIKIPEDIA. BAKER’S CYST.
WIKIPEDIA. BENOXAPROFEN.
WIKIPEDIA. BIRT-HOGG-DUBE SYNDROME.
WIKIPEDIA. BLADDER CANCER.
WIKIPEDIA. BLEPHARITIS.
WIKIPEDIA. BOWEL OBSTRUCTION.
WIKIPEDIA. BRADFORD HILL CRITERIA.
WIKIPEDIA. BRAIN ABSCESS.
WIKIPEDIA. BRAIN TUMOR.
WIKIPEDIA. BRANDY.
WIKIPEDIA. BREAST CANCER.
WIKIPEDIA. CANCER PREVENTION.
WIKIPEDIA. CANNABINOID HYPEREMESIS SYNDROME.
WIKIPEDIA. CARBONYL SULFIDE.
WIKIPEDIA. CARCINOID.
WIKIPEDIA. CARDIAC MYXOMA.
WIKIPEDIA. CAREGIVER.
WIKIPEDIA. CASE-CONTROL STUDY.
WIKIPEDIA. CATASTROPHIC ANTIPHOSPHOLIPID SYNDROME. ACCESSED : OCT 13, 2021.
WIKIPEDIA. CAUDA EQUINA SYNDROME.
WIKIPEDIA. CENTRAL NERVOUS SYSTEM TUMOR.
WIKIPEDIA. CERIVASTATIN.
WIKIPEDIA. CERVICAL CANCER.
WIKIPEDIA. CERVICAL SPINAL STENOSIS.
WIKIPEDIA. CHELITIS.
WIKIPEDIA. CHILDHOOD CANCER.
WIKIPEDIA. CHOLANGIOCARCINOMA.
WIKIPEDIA. CHONDROSARCOMA.
WIKIPEDIA. CHORDOMA.
WIKIPEDIA. CHROMOBLASTOMYCOSIS.
WIKIPEDIA. CHRONIC LIVER DISEASE.
WIKIPEDIA. CHRONIC MYELOGENOUS LEUKEMIA.
WIKIPEDIA. CIGARETTE.
WIKIPEDIA. CIGUATERA FISH POISONING.
WIKIPEDIA. CIPROFLOXACIN.
WIKIPEDIA. CISAPRIDE.
WIKIPEDIA. CLIOQUINOL.
WIKIPEDIA. CLOBUTINOL.
WIKIPEDIA. CLUBFOOT.
WIKIPEDIA. COHORT STUDY.
WIKIPEDIA. CONSTIPATION.
WIKIPEDIA. CONSTRICTION RING SYNDROME.
WIKIPEDIA. CORONARY ARTERY ANEURYSM.
WIKIPEDIA. CRANIOPHARYNGIOMA.
WIKIPEDIA. CRONOBACTER.
WIKIPEDIA. CROSS-SECTIONAL STUDY.
WIKIPEDIA. CRYPTOCOCCOSIS.
WIKIPEDIA. CRYPTOCOCCUS NEOFORMANS.
WIKIPEDIA. CURCUMIN.
WIKIPEDIA. CUTANEOUS LARVA MIGRANS.
WIKIPEDIA. CYSTINOSIS.
WIKIPEDIA. CYTOMEGALOVIRUS RETINITIS.
WIKIPEDIA. DACLIZUMAB.
WIKIPEDIA. DECOMPRESSION SICKNESS.
WIKIPEDIA. DELAYED SLEEP PHASE DISORDER.
WIKIPEDIA. DIARRHEA.
WIKIPEDIA. DIFFUSE INTRINSIC PONTINE GLIOMA.
WIKIPEDIA. DILATION AND CURETTAGE.
WIKIPEDIA. DIPLOPIA.
WIKIPEDIA. DISORDERS OF SEX DEVELOPMENT.
WIKIPEDIA. DUCTAL CARCINOMA IN SITU.
WIKIPEDIA. DYSAUTONOMIA.
WIKIPEDIA. DYSLEXIA.
WIKIPEDIA. DYSMELIA.
WIKIPEDIA. ELEPHANTIASIS.
WIKIPEDIA. EMBRYONAL TUMOUR WITH MULTILAYERED ROSETTES
WIKIPEDIA. EMERGENCY CONTRACEPTION.
WIKIPEDIA. EMMONSIOSIS.
WIKIPEDIA. ENDOMETRIAL CANCER.
WIKIPEDIA. EPENDYMOMA
WIKIPEDIA. EPIDERMYOLYSIS BULLOSA.
WIKIPEDIA. ESTHESIONEUROBLASTOMA.
WIKIPEDIA. EWING’S SARCOMA.
WIKIPEDIA. EXCESSIVE DAYTIME SLEEPINESS.
WIKIPEDIA. EXTRACRANIAL GERM CELL TUMOR.
WIKIPEDIA. FAMILIAL ADENOMATOUS POLYPOSIS.
WIKIPEDIA. FECAL IMPACTION.
WIKIPEDIA. FENFLURAMINE.
WIKIPEDIA. FEVER OF UNKNOWN ORIGIN.
WIKIPEDIA. FONDAPARINUX.
WIKIPEDIA. FORM FDA 483.
WIKIPEDIA. FUMONISIN.
WIKIPEDIA. GASTROINTESTINAL STROMAL TUMOR.
WIKIPEDIA. GERM CELL TUMOR.
WIKIPEDIA. GERMINOMA.
WIKIPEDIA. GESTATIONAL DIABETES.
WIKIPEDIA. GESTATIONAL TROPHOBLASTIC DISEASE.
WIKIPEDIA. GLIOBLASTOMA.
WIKIPEDIA. GLIOMA.
WIKIPEDIA. HAEMOPHILUS DUCREYI.
WIKIPEDIA. HEAD AND NECK CANCER.
WIKIPEDIA. HEALTH EQUITY.
WIKIPEDIA. HEART FAILURE.
WIKIPEDIA. HEART TRANSPLANTATION.
WIKIPEDIA. HEREDITARY LEIOMYOMATOSIS AND RENAL CELL CANCER SYNDROME.
WIKIPEDIA. HEREDITARY NONPOLYPOSIS COLORECTAL CANCER.
WIKIPEDIA. HODGKIN LYMPHOMA.
WIKIPEDIA. HOOKWORM VACCINE.
WIKIPEDIA. HORIZONTAL GENE TRANSFER.
WIKIPEDIA. HYDRAZINE SULFATE.
WIKIPEDIA. HYPERFIBRINOLYSIS.
WIKIPEDIA. IDIOPATHIC HYPERSOMNIA.
WIKIPEDIA. INBORN ERRORS OF METABOLISM.
WIKIPEDIA. INFANT RESPIRATORY DISTRESS SYNDROME.
WIKIPEDIA. INFANTILE APNEA.
WIKIPEDIA. INFANTILE FIBROSARCOMA.
WIKIPEDIA. INTERRUPTED AORTIC ARCH.
WIKIPEDIA. INTESTINE TRANSPLANTATION.
WIKIPEDIA. IRREGULAR SLEEP-WAKE RHYTHM.
WIKIPEDIA. JET LAG.
WIKIPEDIA. JUVENILE IDIOPATHIC ARTHRITIS. ACCESSED : APR 19, 2022.
WIKIPEDIA. KAPOSI’S SARCOMA.
WIKIPEDIA. KAVA.
WIKIPEDIA. KIDNEY CANCER.
WIKIPEDIA. KIDNEY TRANSPLANTATION.
WIKIPEDIA. KNOCKOUT.
WIKIPEDIA. LACTIC ACIDOSIS.
WIKIPEDIA. LANGYA HENIPAVIRUS.
WIKIPEDIA. LARYNGEAL CANCER.
WIKIPEDIA. LEIOMYOSARCOMA.
WIKIPEDIA. LENALIDOMIDE.
WIKIPEDIA. LETHAL INJECTION.
WIKIPEDIA. LEUKEMIA.
WIKIPEDIA. LIPOPOLYSACCHARIDE.
WIKIPEDIA. LIST OF HUMAN STAMPEDES AND CRUSHES.
WIKIPEDIA. LIST OF PEOPLE WITH MULTIPLE SCLEROSIS.
WIKIPEDIA. LIVER CANCER.
WIKIPEDIA. LIVER TRANSPLANTATION.
WIKIPEDIA. LONGITUDINAL STUDY.
WIKIPEDIA. LORENZO’S OIL.
WIKIPEDIA. LUMBAR SPINAL STENOSIS.
WIKIPEDIA. LUNG TRANSPLANTATION.
WIKIPEDIA. LYMPHATIC FILARIASIS.
WIKIPEDIA. MACITENTAN.
WIKIPEDIA. MACROCYTIC ANEMIA.
WIKIPEDIA. MALE BREAST CANCER.
WIKIPEDIA. MANGETIC SEIZURE THERAPY.
WIKIPEDIA. MEDICAL ABORTION.
WIKIPEDIA. MEDULLOBLASTOMA.
WIKIPEDIA. MEDULLOEPITHELIOMA.
WIKIPEDIA. MEGALOBLASTIC ANEMIA.
WIKIPEDIA. MELPHALAN FLUFENAMIDE.
WIKIPEDIA. MENINGIOMA.
WIKIPEDIA. METASTASIS.
WIKIPEDIA. METHANOL.
WIKIPEDIA. MIDNIGHT SUN (2018).
WIKIPEDIA. MITOMYCIN C.
WIKIPEDIA. MITOXANTRONE.
WIKIPEDIA. MORPHEA.
WIKIPEDIA. MULTIPLE ENDOCRINE NEOPLASIA.
WIKIPEDIA. MULTIPLE MYELOMA.
WIKIPEDIA. MYCETOMA.
WIKIPEDIA. MYCOSIS FUNGOIDES.
WIKIPEDIA. MYELOPROLIFERATIVE NEOPLASM.
WIKIPEDIA. NATIONAL COALITION FOR CANCER SURVIVORSHIP.
WIKIPEDIA. NATURAL HISTORY STUDY.
WIKIPEDIA. NEPHROSIS.
WIKIPEDIA. NESTED CASE-CONTROL STUDY.
WIKIPEDIA. NEVOID BASAL-CELL CARCINOMA SYNDROME.
WIKIPEDIA. NON-24-HOUR SLEEP-WAKE DISORDER
WIKIPEDIA. NON-GONOCOCCAL URETHRITIS.
WIKIPEDIA. NON-HODGKIN LYMPHOMA.
WIKIPEDIA. NON-SMALL-CELL LUNG CARCINOMA.
WIKIPEDIA. NONTUBERCULOUS MYCOBACTERIA.
WIKIPEDIA. NUT CARCINOMA.
WIKIPEDIA. OBESITY.
WIKIPEDIA. OCULAR LARVA MIGRANS.
WIKIPEDIA. OLARATUMAB.
WIKIPEDIA. OLIGODENDROGLIOMA.
WIKIPEDIA. ONCOGENOMICS.
WIKIPEDIA. ORAL CANCER.
WIKIPEDIA. OROPHARYNGEAL CANCER.
WIKIPEDIA. OSTEOSARCOMA.
WIKIPEDIA. OVARIAN GERM CELL TUMORS.
WIKIPEDIA. OVARIAN TUMOR.
WIKIPEDIA. PAMIDRONIC ACID.
WIKIPEDIA. PANCREAS TRANSPLANTATION.
WIKIPEDIA. PANCREATIC CANCER.
WIKIPEDIA. PANCREATIC NEUROENDOCRINE TUMOR.
WIKIPEDIA. PARAGANGLIOMA.
WIKIPEDIA. PARANASAL SINUS AND NASAL CAVITY CANCER.
WIKIPEDIA. PARATHYROID CARCINOMA.
WIKIPEDIA. PAROXYSMAL HAND HEMATOMA.
WIKIPEDIA. PEGCETACOPLAN.
WIKIPEDIA. PENILE CANCER.
WIKIPEDIA. PERNICIOUS ANEMIA.
WIKIPEDIA. PERSISTENT FETAL CIRCULATION.
WIKIPEDIA. PHALLOPLASTY.
WIKIPEDIA. PHENFORMIN.
WIKIPEDIA. PHENYLPROPANOLAMINE.
WIKIPEDIA. PHEOCHROMOCYTOMA.
WIKIPEDIA. PHOCOMELIA.
WIKIPEDIA. PILOCYTIC ASTROCYTOMA.
WIKIPEDIA. PLASMA CELL DYSCRASIAS.
WIKIPEDIA. PLEURAL EFFUSION.
WIKIPEDIA. PLEURISY.
WIKIPEDIA. PNEUMOBILIA.
WIKIPEDIA. PNEUMOTHORAX.
WIKIPEDIA. POST-CHEMOTHERAPY COGNITIVE IMPAIRMENT
WIKIPEDIA. PRIMARY CENTRAL NERVOUS SYSTEM LYMPHOMA.
WIKIPEDIA. PRIMARY CILIARY DYSKINESIA.
WIKIPEDIA. PRIMORDIAL DWARFISM.
WIKIPEDIA. PURPURA FULMINANS.
WIKIPEDIA. PYELONEPHRITIS.
WIKIPEDIA. RADIATION ENTEROPATHY.
WIKIPEDIA. RADIATION-INDUCED COGNITIVE DECLINE.
WIKIPEDIA. RAMSAY HUNT SYNDROME TYPE 2.
WIKIPEDIA. RARE DISEASES ACT OF 2002.
WIKIPEDIA. REFLEX ASYSTOLIC SYNCOPE.
WIKIPEDIA. REMINISCENCE THERAPY.
WIKIPEDIA. RETINOBLASTOMA.
WIKIPEDIA. RHABDOMYOLYSIS.
WIKIPEDIA. RHABDOMYOSARCOMA.
WIKIPEDIA. ROFECOXIB.
WIKIPEDIA. SALIVARY GLAND TUMOR (TUMOUR, MUCOUS GLAND ADENOMA)
WIKIPEDIA. SALVAGE THERAPY.
WIKIPEDIA. SARCOIDOSIS.
WIKIPEDIA. SEZARY DISEASE.
WIKIPEDIA. SHIFT WORK SLEEP DISORDER.
WIKIPEDIA. SHIGA TOXIN.
WIKIPEDIA. SICKLE CELL DISEASE.
WIKIPEDIA. SILYBUM MARIANUM.
WIKIPEDIA. SKIN CANCER.
WIKIPEDIA. SLEEP APNEA.
WIKIPEDIA. SLEEP DEPRIVATION.
WIKIPEDIA. SLEEP STUDY.
WIKIPEDIA. SMALL-CELL CARCINOMA.
WIKIPEDIA. SMOKING CESSATION.
WIKIPEDIA. SUBACUTE MYELO-OPTIC NEUROPATHY.
WIKIPEDIA. SUPERIOR VENA CAVA SYNDROME.
WIKIPEDIA. SYNOVIAL SARCOMA.
WIKIPEDIA. SYNTHETIC CONTROL METHOD.
WIKIPEDIA. TEGASEROD.
WIKIPEDIA. TESTICULAR CANCER.
WIKIPEDIA. THALASSEMIA.
WIKIPEDIA. THALIDOMIDE.
WIKIPEDIA. THYMUS TRANSPLANTATION.
WIKIPEDIA. THYROID CANCER.
WIKIPEDIA. TIRZEPATIDE.
WIKIPEDIA. TOXOCARIASIS.
WIKIPEDIA. TRANSIENT TACHYPNEA OF THE NEWBORN.
WIKIPEDIA. TRANSMYOCARDIAL REVASCULARIZATION.
WIKIPEDIA. UMBRRALISIB.
WIKIPEDIA. UNDIFFERENTIATED PLEOMORPHIC SARCOMA.
WIKIPEDIA. UTERINE SARCOMA.
WIKIPEDIA. UTERUS TRANSPLANTATION.
WIKIPEDIA. VACUUM ASPIRATION.
WIKIPEDIA. VAGINAL CANCER.
WIKIPEDIA. VAGINISMUS.
WIKIPEDIA. VALDECOXIB.
WIKIPEDIA. VALRUBICIN.
WIKIPEDIA. VARICOSE VEINS.
WIKIPEDIA. VASCULAR DEMENTIA.
WIKIPEDIA. VASCULITIS.
WIKIPEDIA. VENOM.
WIKIPEDIA. VENTILATOR.
WIKIPEDIA. VISCERAL LARVA MIGRANS.
WIKIPEDIA. VITAMIN A DEFICIENCY.
WIKIPEDIA. VITAMIN B12 DEFICIENCY.
WIKIPEDIA. VITAMIN C.
WIKIPEDIA. VON HIPPEL-LINDAU DISEASE.
WIKIPEDIA. VULVAR CANCER.
WIKIPEDIA. WELLENS’ SYNDROME.
WIKIPEDIA. WILMS’ TUMOR.
WIKIPEDIA. WOLFF-PARKINSON-WHITE SYNDROME.
WIKIPEDIA. XERODERMA PIGMENTOSUM.
WS GLOBAL PATIENT REGISTRY. ACCESSED : NOV 8, 2021.
X-WITHDRAWN-JUL 2022. US FDA. GUIDANCE. EFFECTS OF THE COVID-19 PUBLIC HEALTH EMERGENCY ON FORMAL MEETINGS AND USER FEE APPLICATIONS FOR MEDICAL DEVICES - QUESTIONS AND ANSWERS (REVISED). DEC 2020.