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Medical Devices

FDA Warning on Abbott Trifecta Heart Valves

FDA issues a letter to healthcare providers warning about the potential risk of early structural valve deterioration with Abbott Trifecta heart valves...

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Biologics

FDA Raises Guillain-Barre Monitoring on RSV Vaccine

FDA proposes that Pfizer include Guillain-Barr syndrome and other immune-mediated demyelinating conditions in a pharmacovigilance plan if the companys...

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Federal Register

Neovascular Age-Related Macular Degeneration Guide

Federal Register notice: FDA posts a draft guidance entitled Neovascular Age-Related Macular Degeneration: Developing Drugs for Treatment.

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Human Drugs

Verrica Pharma NDA Resubmitted for Skin Infection

FDA accepts for review a Verrica Pharmaceuticals NDA resubmission for VP-102 to treat molluscum contagiosum, described by the Centers for Disease Cont...

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Human Drugs

FDA Debars Ex-Indivior CEO for 5 Years

FDA issues a five-year debarment order against former Indivior CEO Shaun Thaxter based on an earlier misdemeanor conviction.

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Human Drugs

SpringWorks NDA for Desmoid Tumor Drug

FDA accepts for priority review a SpringWorks Therapeutics NDA for nirogacestat, an investigational gamma secretase inhibitor for treating adults with...

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Human Drugs

CDER Taps Deputy Furman as Compliance Director

CDER promotes Office of Compliance deputy director Jill Furman as permanent director after serving as acting director since previous head Don Ashley r...

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Medical Devices

FDA Grants EUA for First OTC Flu/Covid Test

FDA issues Lucira an emergency use authorization for the first over-the-counter at-home diagnostic test for detecting influenza A and B, and Covid-19.

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Human Drugs

Congress Urges FDA to Do More on Ibuprofen Shortage

Six House Democrats urge FDA to do more to help resolve the ongoing shortage of pediatric ibuprofen and acetaminophen.

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Federal Register

Chantix Not Withdrawn Due to Safety/Efficacy

Federal Register notice: FDA determines that Pfizers smoking cessation drug Chantix (varenicline tartrate) tablets, 0.5 mg and 1 mg, have not been wit...