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FDA Warning on Abbott Trifecta Heart Valves

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

FDA Raises Guillain-Barre Monitoring on RSV Vaccine

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

Neovascular Age-Related Macular Degeneration Guide

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Federal Register notice: FDA posts a draft guidance entitled Neovascular Age-Related Macular Degeneration: Developing Drugs for Tr...

Verrica Pharma NDA Resubmitted for Skin Infection

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

FDA Debars Ex-Indivior CEO for 5 Years

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

SpringWorks NDA for Desmoid Tumor Drug

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

CDER Taps Deputy Furman as Compliance Director

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CDER promotes Office of Compliance deputy director Jill Furman as permanent director after serving as acting director since previo...

FDA Grants EUA for First OTC Flu/Covid Test

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

Congress Urges FDA to Do More on Ibuprofen Shortage

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

Chantix Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Pfizers smoking cessation drug Chantix (varenicline tartrate) tablets, 0.5 mg and 1 m...