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Attorneys Discuss New FDA Draft NCI Guidance

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Two Axinn attorneys explain a new FDA draft guidance on new clinical investigation exclusivity and ways that some NDA and sNDA app...

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FDA Draft Guidance for Medical Devices Intended for Weight Loss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FDA posts a draft guidance entitled Medical Devices with Indications Associated with Weight Loss - Premarket Considerations.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

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 ...

FDA OKs Bristol Myers Squibbs Sotyktu for Psoriatic Arthritis

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FDA approves Bristol Myers Squibs Sotyktu (deucravacitinib), an oral therapy for treating adults with active psoriatic arthritis.

4 Major Issues Plaguing FDA: Newsweek

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A Newsweek report details four major issues it says have plagued FDA in its first year under commissioner Marty Makary.

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 ...