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FDA releases a final guidance entitled Recommended Acceptable Intake Limits for Nitrosamine Drug Substance-Related Impurities (NDS...[ Price : $8.95]
FDA sends Mesoblast a second complete response letter on its BLA for remestemcel-L for treating pediatric steroid-refractory acute...[ Price : $8.95]
FDA approves new labeling to permit several Biosense Webster cardiac ablation devices to be used without relying on a fluoroscopy ...[ Price : $8.95]
Federal Register notice: FDA announces a 10/18-19 public meeting entitled Mitigating Clinical Study Disruptions During Disasters a...[ Price : $8.95]
Federal Register notice: FDA posts a draft guidance entitled PDUFA Waivers, Reductions, and Refunds for Fixed-Combinations and Sin...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Fixed-Combinations and Single-Entity Versions of Previously...[ Price : $8.95]
A bipartisan group of 28 House members asks FDA about the potential for drug shortages if supply chain members cant meet the 11/27...[ Price : $8.95]
FDA publishes a guidance explaining the process for requesting a waiver, exception, or exemption from provisions of the Drug Suppl...