In the past week, the FDA authorized Pfizer’s and Merck’s oral antivirals for the treatment of COVID-19. The Biden-Harris Administration released the Trucking Action Plan. The CDC endorsed ACIP recommendation of preference...more
12/24/2021
/ 510(k) RTA ,
Abbreviated New Drug Application (ANDA) ,
CDRH ,
Coronavirus/COVID-19 ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Healthcare ,
Infectious Diseases ,
Life Sciences ,
Medical Devices ,
Moderna Inc. ,
Pfizer ,
Pharmaceutical Industry ,
Prescription Drugs ,
R&D ,
Supply Chain ,
Vaccinations
The Food and Drug Administration released guidance for the use of convalescent plasma to treat COVID-19 to supplement its recently issued emergency use authorization. Our Food, Drug & Device/FDA Team analyzes the specifics of...more
Our FDA Compliance & Enforcement Team examines the Food and Drug Administration’s decision to temporarily postpone routine surveillance domestic inspections in the wake of the continuing coronavirus (COVID-19) outbreak....more
Our Food, Drug & Device/FDA Team discusses why the Food & Drug Administration is engaging with personal protective equipment (PPE) manufacturers and how it’s providing information to health care providers to mitigate...more
Our FDA Compliance & Enforcement Team examines the Food & Drug Administration’s decision to stop overseas inspections in the wake of the continuing coronavirus (COVID-19) outbreak....more