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.
FDA issues two draft guidances with studies and information it recommends be included in 510(k) submissions for blood glucose monitors intended for he...
Federal Register notice: FDA issues 22 new and 41 revised ANDA product-specific guidances.
Federal Register notice: FDA makes available a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments ...
Federal Register notice: FDA announces a 1/17/2019 Endocrinologic and Metabolic Drugs Advisory Committee meeting to discuss a Sanofi-Aventis NDA for d...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory Improvement Amendmen...
FDA issues a drug safety alert to warn about rare but serious cases of stroke and tears in the lining of arteries in the head and neck that have occur...