*Developments: FDA (Archive 2019-2020)

Parents

2019: FDA approves 5 new costly drugs well ahead of PDUFA dates – Endpoints News
2019: FDA delivers regulatory guidance on AI software and clinical decision-making aids
2019: FDA Issues Draft Guidance to Enhance Clinical Trial Diversity_healthitanalytics.com
2019: FDA targets De Novo path to shepherd medical software through Pre-Cert
2019: FDA Updates Draft Guidance on Clinical Decision Support Software_healthitanalytics.com
2019: IBM, Walmart Collaborate for FDA Blockchain Pilot Programhealthitanalytics.com
2020: Congress urges FDA to better police, evaluate COVID-19 antibody tests
2020: Digital Health Center of Excellence
2020: Emergency authorization granted to COVID-19 ICU prediction software_CLEW Medical
2020: FDA explains impact of COVID-19 on applications, formal meetings
2020: FDA Lays Out Plan for Coronavirus Medical Countermeasures
2020: FDA Participates in 5 New Communities
2020: FDA ranks the performance of 58 molecular coronavirus tests from major developers
2020: The FDA Response To COVID-19 At Six Months: Regulatory Innovation In The Face Of A Pandemic_www.healthaffairs.org
2020: To prep for a complicated flu season, FDA greenlights CDC’s combined influenza & COVID-19 test
2020: With 45 new drug approvals in 2019, ‘friendly’ FDA is here to stay