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CDRH Strategic Group Org. Structure Correction

[ Price : $8.95]

Federal Register notice: FDA corrects an 8/14 notice that announced a modification to the organizational structure of CDRHs Office...

Drug Firms $300 Million Fine Over Price-Fixing

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The U.S. Justice Department fines Teva Pharmaceuticals USA and Glenmark Pharmaceuticals over $300 million in deferred prosecution ...

OPDP Cites Exeltis Promos on Social Media

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CDER Office of Prescription Drug Promotion cites Exeltis USA for making false or misleading claims in a social media post.

Device Cybersecurity Guide Coming by 9/30: FDA

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FDA plans to finalize by 9/30 its draft guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Cont...

Eylea OKd After Fixing Inspection Findings

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Regeneron Pharmaceuticals wins FDA approval for high-dose Eylea HD (aflibercept) injection 8 mg after resolving inspection concern...

Califf to Put Pressure on Indian Drug Makers

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HHS secretary Xavier Becerra announces that FDA commissioner Robert Califf will be heading soon to India to meet with Indian regul...

Bortezomib Not Removed Over Safety/Efficacy

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Federal Register notice: FDA determines that Accord Healthcares bortezomib solution was not withdrawn due to safety or effectivene...

FDA Debars Winne Over Testing Lab

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Federal Register notice: FDA denies a request for a hearing and permanently debars David Roy Winne from providing services related...

Anika Gains Rotator Cuff Implant Clearance

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FDA clears an Anika Therapeutics 510(k) for the Integrity Implant System, intended for use in augmenting an injured tendon to prom...

Veopoz OKd and Eylea Issues Fixed: Regeneron

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FDA approves a Regeneron Pharmaceuticals BLA for Veopoz (pozelimab-bbfg) for treating adult and pediatric patients one year of age...