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Shionogi Urinary Tract Infection Drug Approved

[ Price : $8.95]

FDA approves a Shionogi & Co. NDA for Fetroja (cefiderocol), an antibacterial drug for treating patients 18 years of age or older ...

Guidance on Smallpox Drug Development

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FDA issues a final guidance entitled Smallpox (Variola Virus) Infection: Developing Drugs for Treatment or Prevention.

FDA Funds Quality Management Research Project

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FDA funds a $1.7 million two-year project in which five universities will study quality management in FDA drug manufacturing opera...

Final Guide on Export Certificate Denials

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Federal Register notice: FDA makes available a final guidance entitled Process to Request a Review of FDAs Decision Not to Issue C...

Info Collection on Cardiovascular Outcome Claims Guide

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Federal Register notice: FDA sends to OMB an information collection extension for Hypertension Indication: Drug Labeling For Cardi...

Ultromics EchoGo Core Heart Scan Checker Cleared

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FDA clears an Ultromics 510(k) for its image analysis system EchoGo Core, which uses artificial intelligence to automate the analy...

Info Collection Extension on Device Quality System

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Federal Register notice: FDA submits to OMB an information collection extension for Medical Devices: Current Good Manufacturing Pr...

FDA Warns Dollar Tree on Unsafe OTC Drugs

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FDA warns Dollar Tree about its receipt of over-the-counter drugs manufactured by foreign contract firms that have received FDA Wa...

AstraZeneca/Merck NDA for Neurofibromatosis Drug

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FDA accepts for priority review an AstraZeneca and Merck NDA for MEK 1/2 inhibitor selumetinib for pediatric patients with neurofi...

ICH Q12 Guidance Extends Quality by Design: Analysis

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CGMP consultant Dave Elder analyzes a draft International Conference on Harmonization guidance on technical and regulatory conside...