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.
Federal Register notice: FDA seeks comments on a proposed study entitled Endorser Status and Explicitness of Payment in Direct-to-Consumer Promotion....
Federal Register notice: FDA makes available a draft guidance entitled Arthroscopy Pump Tubing Sets Intended for Multiple Patient Use Premarket Notif...
FDA releases six final and one draft guidance to further gene therapy product development.
FDA releases the FDA-483 with four observations from an inspection at the Athenex Pharma Solutions outsourcing facility.