FDA requires a new warning and updates on clozapine products and related constipation risks, which can progress to serious bowel complications.
Federal Register notice: FDA sends to OMB a proposed Study of Oncology Indications in Direct-to-Consumer Television Advertising.
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.