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OrthoPediatrics Gains Clearance for PediFoot

[ Price : $8.95]

FDA clears an OrthoPediatrics 510(k) for its new PediFoot Deformity Correction System for pediatric foot fractures and deformities...

Nabriva Antibiotic Approved for Pneumonia

[ Price : $8.95]

FDA approves a Nabriva Therapeutics NDA for Xenleta (lefamulin) for treating adults with community-acquired bacterial pneumonia.

FDA Rejects sNDA for Vandas Jet Lag Drug

[ Price : $8.95]

FDA sends Vanda Pharmaceuticals a complete response letter on supplemental NDA for Hetlioz (tasimelteon) for treating jet lag diso...

FDA Science Forum Set for 9/12

[ Price : $8.95]

Federal Register notice: FDA announces a 9/12 public workshop entitled FDA Science Forum 2019.

Guide Evaluating Vet Drug Metabolism/Residue Kinetics

[ Price : $8.95]

Federal Register notice: FDA makes available a guidance on studies to evaluate the metabolism and residue kinetics of veterinary d...

Info Collection Extension for Review Transparency

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension for evaluating the agencys review transparency and c...

Sun Gets FDA NAI Inspection at Troubled Plant

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Sun Pharmaceutical Industries moves past previous GMP issues at its once-troubled Halol, India plant after FDA classifies a recent...

Genus Petition Against Lannett Cocaine NDA

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Genus Lifesciences petitions FDA seeking an acceptance rescission of a Lannett 505(b)(2) NDA for a cocaine hydrochloride product.

Latest Federal Register Notices

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FDA Review posts the Federal Register notice for the week ending 8/16/2019.

Zimmers Spinal Tether OKd for Idiopathic Scoliosis

[ Price : $8.95]

FDA approves Zimmer Biomet Spines The Tether Vertebral Body Tethering System for treating idiopathic scoliosis.