A Tufts Center for the Study of Drug Development analysis shows that central nervous system drugs take longer to develop and approve than drugs in oth...
FDA warns two Medtronic manufacturing facilities about Quality System violations in their production of cardiac medical devices.
The HHS Inspector General outlines steps FDA could take to better integrate cybersecurity concerns into its medical device reviews before granting mar...
Federal Register notice: FDA announces a 10/11 Anesthetic and Analgesic Drug Products Advisory Committee meeting.
Federal Register notice: FDA announces a 10/17 joint advisory committee meeting to review an irritable bowel syndrome drug.
FDA warns Canadas Lernapharm about CGMP violations in its production of finished drugs.
Four pharmaceutical stakeholders submit comments on an FDA draft guidance on writing the Indications and Usage section in product labeling.
Indias Lupin says an FDA inspection at its Tarapur drug manufacturing facility closed with one observation the company considers to be a procedural de...