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FDA says it is looking for nine drug establishments to volunteer to test CDERs new QMM prototype assessment protocol.[ Price : $8.95]
Federal Register notice: FDA makes available a final guidance entitled Revising ANDA Labeling Following Revision of the RLD Labeli...[ Price : $8.95]
FDA releases the form FDA-483 with 11 observations from an inspection at the Deerfield, FL-based Hybrid Pharma outsourcing facilit...[ Price : $8.95]
The CDER Office of Clinical Pharmacology launches a Web site to give healthcare professionals examples of drug interactions involv...[ Price : $8.95]
FDA approves an expanded indication for Regeneron Pharmaceuticals and Sanofis Dupixent (dupilumab) for treating pediatric patients...[ Price : $8.95]
FDA clears an Envisionit Deep AI 510(k) for its artificial intelligence (AI)-assisted chest x-ray device, Radify Triage, for triag...[ Price : $8.95]
Federal Register notice: FDA announces the issuance of Emergency Use Authorizations for 22 medical Covid-related medical devices a...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Good Manufacturing Practice for Active Pharmaceutical Ingre...