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FDA Grant to C-Path for Neonate Drug Study

[ Price : $8.95]

FDA awards a multi-year grant to C-Path to advance standards and methodologies designed to generate real-world evidence from real-...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include KVK-Tech and Shilpa Medicare Limited.

Abiomeds Cardiopulmonary Bypass Cleared by FDA

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FDA grants Abiomed 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 Syst...

Revised Template for Covid Antigen Tests

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FDA revises its template that provides current recommendations about data and information that should be submitted to support an E...

Santen NDA Accepted for Eye Condition

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FDA accepts for review a Santen NDA for cyclosporine topical ophthalmic emulsion, 0.1% for treating severe vernal keratoconjunctiv...

AstraZeneca Hold Lifted on Covid Vaccine Trial

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FDA lifts a clinical hold against AstraZeneca and the University of Oxford to resume clinical trials of their coronavirus vaccine,...

Covid Travel Ban Blocks Spectrum Cancer Drug Inspection

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FDA defers a review action on a Spectrum Pharmaceuticals BLA for Rolontis (eflapegrastim) because of a Covid-19-related travel res...

Medtronic PMA OKd for Abre Venous Stent

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FDA approves a Medtronic PMA for its Abre venous self-expanding stent system for use in the iliofemoral veins in patients with out...

Janssen Files sNDA for Xarelto Plus Aspirin in PAD

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Janssen files a supplemental NDA for a new indication to expand Xareltos (rivaroxaban) use in patients with peripheral artery dise...

FDA/Pharmacy Boards MOU for Compounded Drugs

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Federal Register notice: FDA makes available a final standard memorandum of understanding entitled Memorandum of Understanding Add...