CBER director Peter Marks tells an online health summit that a Covid vaccine EUA could be approved within weeks after a vaccine meets efficacy require...
Federal Register notice: FDA makes available a final guidance entitled Expiration Dating of Unit-Dose Repackaged Solid Oral Dosage Form Drug Products....
FDA accepts from Merck two supplemental BLAs for Keytruda (pembrolizumab) and its use in triple-negative breast cancer.
Federal Register notice: FDA announces a 9/8-9 virtual Orthopedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee meeting t...
Two law professors say FDAs guidances on emergency use authorization for laboratory-developed Covid tests was a major regulatory overreach that led to...
FDA posts a new template for commercial developers to help them develop and submit emergency use authorization requests for Covid-19 diagnostic tests ...
Federal Register notice: FDA makes available a draft guidance entitled Setting Endotoxin Limits During Development of Investigational Oncology Drugs a...
Federal Register notice: FDA issues a final rule to require electronic submission of certain postmarketing safety reports for approved new animal drug...