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Continue Modernizing Foreign Inspections: Study

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Academic researchers call on FDA to continue to modernize its foreign drug inspection program and overcome differences in inspecti...

FDA Draft Guidance for Medical Devices Intended for Weight Loss

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FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.

AI Has Saved FDA 17,000 Hours: Makary

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FDA commissioner Marty Makary explains how the agency is using AI to modernize tedious tasks performed by humans to make drug revi...

FDA Panel Backs Trivalent Influenza Vaccine for 2027 Season

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FDAs Vaccines and Related Biological Products Advisory Committee votes to recommend that seasonal influenza vaccines for the 20262...

FDA Posts 483 Related to New Novo Nordisk Warning Letter

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FDA releases the Form 483 behind a 3/5 Warning Letter to Novo Nordisk that cited serious violations of postmarketing adverse drug ...

CGMP Violations in Tentamus India Inspection

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FDA warns Indias Tentamus India Private Limited contract laboratory about significant violations of CGMP regulations.

Advita Ortho Hit with 7 QS Violations

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FDA warns Exactech, doing business as Advita Ortho, about Quality System violations in its production of accessories for the Equin...

Rosemont Pharma Gets Complete Response on Valacyclovir

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FDA posts a 3/5 complete response letter to Rosemont Pharmaceuticals, rejecting the companys NDA for valacyclovir.

Sen. Johnson Probing FDA Rare Disease Denials

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Senator Ron Johnson (R-WI) launches a congressional investigation into FDAs recent decisions to reject or delay treatments for rar...

FDA Opens New, Searchable Adverse Event Platform

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FDA launches its new Adverse Event Monitoring System to ultimately house all adverse events reported on FDA-regulated products on ...