FDAs Anesthetic and Analgesic Drug Products Advisory Committee votes 6 to 4 to not recommend approval of a Pacira Pharmaceuticals supplemental NDA for...
Federal Register notice: FDA announces an 8/13-14 public meeting entitled Pediatric Medical Device Development.
Federal Register notice: FDA makes available a guidance entitled How to Prepare a Pre-Request for Designation (Pre-RFD).
FDA approves AstraZenecas Imfinzi (durvalumab) for treating patients with Stage III non-small cell lung cancer whose tumors are not able to be surgica...
As a means to help bring down rising drug costs, FDA commissioner Scott Gottlieb says the agency is exploring how to allow generic drug firm to acquir...
Two medical device researchers outline benefits and pitfalls of FDA relying on real world evidence in their regulatory decision making.
Federal Register notice: FDA determines that U.S. Pharmaceutical Holdings Lotensin HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5...
Federal Register notice: FDA makes available a draft guidance entitled Standardized Format for Electronic Submission of NDA and BLA Content for the Pl...