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Foldax IDE Approved for New Heart Valve

[ Price : $8.95]

FDA approves a Foldax IDE to begin a clinical study of its Tria biopolymer mitral surgical heart valve.

Gannex Gets Fast Track for NASH Drug

[ Price : $8.95]

FDA grants Gannex a fast track designation for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42, which the company de...

Genentech Gains Shorter Infusion Time with MS Drug

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FDA approves a shorter two-hour infusion time for Genentechs Ocrevus (ocrelizumab) dosed twice-yearly for those living with relap...

Not All Scrubs are Medical Devices: Petition

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A just-filed citizen petition requests that FDA not treat daily-wear uniform scrubs as medical devices.

FDA Explains Surrogate Endpoint Table

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FDA discusses the agencys surrogate endpoint (SE) table that was mandated by the 21st Century Cures Act of 2016.

Device Safety/Performance Based Pathway Guidances

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Federal Register notice. FDA makes available three device-specific final guidance documents for the Safety and Performance Based P...

FDA OKs Genomic Alteration for Therapeutic/Food Pigs

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FDA approves Revivicors intentional genomic alteration in GalSafe pigs for use as food and human therapeutics.

Notice Corrected on Drug Development Tools Guide

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Federal Register notice: FDA corrects an 11/25 notice entitled Qualification Process for Drug Development Tools; Guidance for Indu...

FDA Withdraws 10 No-Longer-Marketed ANDAs

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Federal Register notice: FDA is withdrawing approval of 10 ANDAs from multiple applicants after they notified the agency that the ...

Comments Extended on Electromagnetic Compatibility Guide

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Federal Register notice: FDA extends the comment period on a draft guidance entitled Electromagnetic Compatibility of Medical Devi...