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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 sends Vanda Pharmaceuticals a complete response letter on supplemental NDA for Hetlioz (tasimelteon) for treating jet lag diso...[ Price : $8.95]
Federal Register notice: FDA announces a 9/12 public workshop entitled FDA Science Forum 2019.[ Price : $8.95]
Federal Register notice: FDA makes available a guidance on studies to evaluate the metabolism and residue kinetics of veterinary d...[ Price : $8.95]
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.