*FDA: Key Terms & Designations

Parents

FDA _ CGMP’s (Current Good Manufacturing Practices) requirements for devices in part 820 (21 CFR part 820)
FDA _ CRL (Complete Response Letter)
FDA _ 510(k) Clearance/Approval
FDA _ Accelerated Approval
FDA _ BLA (Biologics License Application)
FDA _ Breakthrough Devices Program
FDA _ Breakthrough Therapy Designation
FDA _ Commissioner's National Priority Voucher (CNPV) Pilot Program
FDA _ CTA (Clinical Trial Application)
FDA _ EUA (Emergency Use Authorization)
FDA _ Fast Track Designation
FDA _ GMP (Good Manufacturing Production)
FDA _ HDE (Humanitarian Device Exemptions)
FDA _ IDE (Investigational Device Exemptions)
FDA _ IND (Investigational New Drug) Application Process
FDA _ MDUFA (Medical Device User Fee Amendment)
FDA _ NDA (New Drug Applications) include new molecular entities as well as new formulations or new manufacturers of existing drugs
FDA _ Orphan Drug Designation
FDA _ PDUFA (Prescription Drug User Fee Act)
FDA _ PMA (Pre Market Approval): Class III
FDA _ Priority Review
FDA _ Priority Review Voucher
FDA _ QIDP (Qualified Infectious Disease Product)
FDA _ Rare Pediatric Disease Designation
FDA _ Regenerative Medicine Advanced Therapy (RMAT)
FDA _ sNDA (supplemental New Drug Application)
FDA _ SPA (Special Protocol Assessment)
FDA Advisory Committee
FDA PCCPs (Predetermined Change Control Plans)