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FDA Approved Ortho BLA for Blood Grouping Reagents

[ Price : $8.95]

FDA approves an Ortho Clinical Diagnostics BLA for the Ortho Sera blood grouping reagents designed for extended phenotype testing ...

FDA Panel to Review Interstitial Cystitis Drug Development

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Federal Register notice: FDA announces a 12/7 Bone, Reproductive and Urologic Drugs Advisory Committee meeting.

FDA Warning Letters Drop on Potential Trump Effect

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FDA watchers worry that a significant recent drop in Warning Letters issued to medical product makers is a sign of President Donal...

Cook Medical Corrects Instructions on Endovascular Graft

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Federal Register notice: FDA makes available a draft guidance entitled Identifying Trading Partners Under the Drug Supply Chain Se...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