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Federal Register notice: FDA makes available a draft guidance entitled Recommendations for Dual 510(k) and Clinical Laboratory Improvement Amendments ...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Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory Improvement Amendmen...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...
Federal Register notice: FDA makes available a draft guidance entitled Select Updates for Recommendations for Clinical Laboratory Improvement Amendmen...
FDA warns that signs and symptoms of a life-threatening side effect called differentiation syndrome are not being identified in patients receiving Cel...
The European Medicines Agency says FDA has confirmed the capability of five more member states to conduct drug inspections.