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Boston Scientific PMA OKd for Stent

[ Price : $8.95]

FDA approves a Boston Scientific PMA for the AGENT Drug-Coated Balloon (DCB), indicated for treating coronary in-stent restenosis ...

Fresh Allograft Heart Valves Regulated by FDA

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FDA affirms its regulation of fresh allograft heart valves in a just-posted letter to healthcare professionals.

Endo Hit with $2 Billion Fine Over Opioid Sales

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Endo Health Solutions agrees to plead guilty in federal court and pay over $2 billion in penalties to resolve criminal and civil i...

FDA Denies Approval/Hearing on Vanda Stalled sNDA

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FDA declines to grant a hearing request by Vanda Pharmaceuticals on a stalled supplemental NDA for Hetlioz (tasimelteon) for treat...

Datex-Ohmeda Air Compressor Recall is Class 1

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FDA classifies as Class 1 a Datex-Ohmeda recall of its EVair 03 (Jun-air) air compressor (model numbers: 1609000 and 1609002) afte...

Allecra NDA Approval for Antibiotic

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FDA approves an Allecra Therapeutics NDA for Exblifep (cefepime/enmetazobactam) for treating complicated urinary tract infections.

Class 1 Correction Recall on Electrodes Updated

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FDA updates a Class 1 recall (correction) of Megadyne Medical Products Mega Soft patient return electrode models to reiterate the ...

FDA Guide on Informed Consent Key Info

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FDA posts a draft guidance on Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigat...

Antibody-Drug Conjugate Pharmacology Guide

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Federal Register notice: FDA makes available a final guidance entitled Clinical Pharmacology Considerations for Antibody-Drug Conj...

Device Recognized Consensus Standards Updated

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Federal Register: FDA announces a publication containing modifications the agency is making to the list of standards it recognizes...