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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.

OrthoPediatrics Gains Clearance for PediFoot

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

Nabriva Antibiotic Approved for Pneumonia

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

Latest Federal Register Notices

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

Panel to Discuss GSK NDA for OTC Nicotine Spray

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Federal Register notice: FDA announces a 9/18 panel meeting on a GlaxoSmithKline NDA for the over-the-counter marketing of nicotin...

Nonclinical Osteoporosis Drug Study Guide

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Federal Register: FDA makes available a final guidance on osteoporosis drug nonclinical studies.

FDA/EMA Study Examines Drug Approval Concordance

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A new study shows that FDA and European Medicines Agency reviewers have a high concordance (9198%) in approving/rejecting new drug...

Zimmers Spinal Tether OKd for Idiopathic Scoliosis

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