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CGMP Deviations in DuPont Avicel Manufacturing

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FDA warns DuPont Nutrition USA about CGMP deviations in its manufacturing of the widely-used drug excipient Avicel.

FDA Discusses 2 New Trilogy Ventilator Issues

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FDA describes two new issues that have occurred in some reworked Philips Respironics Trilogy 100 and 200 ventilators.

FDA Needs More Global Help Against Crime: Hermsen

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Retired FDA top cop Catherine Hermsen says there is a need to expand collaboration with regulators in other countries to combat in...

Reactions to Aduhelm Report Blast FDA Closeness to Industry

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Reactions to a Congressional report on FDAs 2021 controversial review and approval of Biogens Alzheimers drug Aduhelm sharply crit...

FDA Gets $226 Million Spending Boost in Budget Bill

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President Biden signs into law FDAs fiscal year 2023 spending bill as part of the end-year omnibus legislation (HR 2617, Consolida...

FDA Grants Ardelyx Xphozah Appeal

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FDA grants Ardelyx appeal of a complete response letter for its Xphozah to treat adult patients with chronic kidney disease on dia...

Latest Federal Register Notices

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FDA Webview posts the Federal Register notices that published during our annual holiday break.

Cytalux Approved for Lung Cancer Lesion Detection

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FDA approves an On Target Laboratories supplemental NDA for Cytalux (pafolacianine) to help surgeons in identifying lung cancer le...

FDA OKs Ferrings Bladder Cancer Gene Therapy

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FDA approves a Ferring Pharmaceuticals BLA for Adstiladrin (nadofaragene firadenovec-vncg), a non-replicating adenoviral vector...

Panel to Examine Ongoing Covid Vaccine Modifications

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FDA says it is holding a 1/26/2023 meeting of its Vaccines and Related Biological Products Advisory Committee to consider whether ...