FDA and Health Canada issue a notice alerting healthcare providers and facilities about the safe use of Megadyne Medical Products Mega 2000 and Mega S...
Researchers from FDA and other entities recommend ways to improve the collection and analysis of overall survival (OS) data in cancer drug trials.
Federal Register notice: FDA sets the medical device user fee rates for fiscal year 2025.
Federal Register notice: FDA announces the rates for prescription drug user fees for fiscal year 2025.
FDA warns Brooklyn, NY-based Amco International Manufacturing & Design about illegally manufacturing and distributing adulterated automated external d...
The CDER Office of Surveillance and Epidemiology annual report says it contributed to 55 novel drug and therapeutic biologic approvals in 2023.
FDA accepts for review a Vertex Pharmaceuticals NDA for suzetrigine, a selective NaV1.8 pain signal inhibitor for treating moderate-to-severe acute pa...
Federal Register notice: FDA releases fiscal year 2025 rates for generic drug user fees.
