FDA warns Chinas Sunstar Guangzhou about CGMP violations in its production of finished drugs.
Discussions from a joint FDA-MHRA workshop on good clinical practice are published by the American Society for Clinical Pharmacology and Therapeutics.
FDA warns Draegar Medical about manufacturing medical devices without an approved PMA or IDE and with Quality System violations.
FDA says the Teleflex recall of the Glaemed Babi.Plus 12.5 cm pressure relief manifold is Class 1.
FDA approves Boehringer Ingelheim Pharmaceuticals and Eli Lillys Trijardy XR (empagliflozin/linagliptin/metformin HCl) to lower blood sugar in adults ...
FDA releases its latest batch of Warning Letters that includes Baja Fur, Dental-Kosmetik, Draegar Medical Systems and Sunstar Guangzhou.
FDA approves Mercks Dificid (fidaxomicin) oral suspension and tablets for expanded use treating Clostridium difficile infections in children aged six...
FDA posts a draft guidance on Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use - Premarket Notification (510(k)) Submissions.