AdvaMed and other industry groups comment on FDAs recent draft guidance on The Special 510(k) Program, suggesting that the documents proposed text may...
FDA approves a Medifocus PMA supplement for new labeling for its Prolieve Transurethral ThermoDilatation Therapy based on the results from the company...
Federal Register notice: FDA seeks comments on an information collection extension entitled: Oversight of Clinical Investigations: A Risk-Based Approa...
FDA Webview posts the Federal Register notices for the week ending 11/30/2018.
Federal Register notice: FDA makes available a draft guidance entitled Blood Glucose Monitoring Test Systems for Prescription Point-of-Care Use.
Federal Register notice: FDA makes available a draft guidance entitled Self-Monitoring Blood Glucose Test Systems for Over-the-Counter Use.
Federal Register notice: FDA announces a 1/16 Bone, Reproductive and Urologic Drugs Advisory Committee meeting to discuss an Amgen BLA for osteoporosi...
FDA approves a Catalyst Pharmaceuticals NDA for Firdapse (amifampridine) 10 mg tablets for treating adults with Lambert-Eaton Myasthenic Syndrome.