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Cook Medical Corrects Instructions on Endovascular Graft

[ Price : $8.95]

FDA says Cook Medical has initiated a correction to its instructions for use for the Zenith Alpha Thoracic Endovascular Graft.

Draft Guide on Drug Supply Trading Partners

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Federal Register notice: FDA makes available a draft guidance entitled Identifying Trading Partners Under the Drug Supply Chain Se...

FDA Tells Medizone to Use De Novo Pathway for Disinfection Device

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FDA tells Medizone International that it should proceed to market through the de novo classification pathway for its novel Aseptic...

FDA Releases More Details on CDER/ORA Inspection Agreement

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FDA releases more details on a CDER and ORA concept of operations agreement to integrate facility evaluations and inspections for ...

FDA Approves Immune Globulin Rabies Prevention

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FDA approves Kedrion Biopharma and Kmada Ltd.s KedRab [rabies immune globulin (human)] for passive, transient post-exposure prophy...

Guidance on Oncology Drugs for Companion Animals

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Federal Register notice: FDA makes available a guidance for industry #237 entitled Oncology Drugs for Companion Animals.

FDA Approves Teligent ANDA for Clobetasol Propionate Cream

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FDA approves a Teligent ANDA for clobetasol propionate cream USP, 0.05%, emollient.

FDA Approves Adamas Gocovri for Parkinsons Dyskinesia

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FDA approves Adamas Pharmaceuticals Gocovri, the only approved drug indicated to treat dyskinesia in Parkinsons patients receiving...

US Bioservices Corp. Settles Fraud Suit for $13.4 Million

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US Bioservices agrees to pay $13.4 million to resolve claims against it for being part of a kickback scheme involving Novartis Exj...

Hard to Assess Opioid Deterrence: FDA

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FDA researchers discuss difficulties in using post-marketing studies to determine how successful an opioids abuse-deterrent formul...