FDA warns Chinas Hangzhou Karic Commodities about CGMP violations in its production of finished pharmaceuticals.
Four drug companies recommend changes to an FDA draft guidance on developing drugs to treat major depressive disorder.
Sen. Edward Markey says FDA may have ignored REMS signals of inappropriate prescribing of a specific class of fentanyl products.
FDA warns Japans Kyowa Hakko Bio Co. about repeat CGMP deviations in its manufacturing of active pharmaceutical ingredients.
Federal Register notice: FDA makes available a final guidance entitled Microdose Radiopharmaceutical Diagnostic Drugs: Nonclinical Study Recommendatio...
Federal Register notice: FDA makes available a final guidance entitled Quality Attribute Considerations for Chewable Tablets.
FDA extends expiration dates on some EpiPen lots to help ease product shortage.
JAMA deputy editor Gregory Curfman calls for congressional action to resolve the question of who a consumer can sue when injured by a generic drug tha...