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Federal Register notice: FDA sends to OMB an information collection extension for evaluating the agencys review transparency and c...[ Price : $8.95]
Sun Pharmaceutical Industries moves past previous GMP issues at its once-troubled Halol, India plant after FDA classifies a recent...[ Price : $8.95]
Genus Lifesciences petitions FDA seeking an acceptance rescission of a Lannett 505(b)(2) NDA for a cocaine hydrochloride product.[ Price : $8.95]
FDA clears an OrthoPediatrics 510(k) for its new PediFoot Deformity Correction System for pediatric foot fractures and deformities...[ Price : $8.95]
FDA approves a Nabriva Therapeutics NDA for Xenleta (lefamulin) for treating adults with community-acquired bacterial pneumonia.[ Price : $8.95]
FDA Review posts the Federal Register notice for the week ending 8/16/2019.[ Price : $8.95]
Federal Register notice: FDA announces a 9/18 panel meeting on a GlaxoSmithKline NDA for the over-the-counter marketing of nicotin...[ Price : $8.95]
Federal Register: FDA makes available a final guidance on osteoporosis drug nonclinical studies.