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Bulk Drug Substance Listing Reopened for Comments

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Federal Register notice: FDA reopens the comment period for a notice that appeared in the 7/31/2020 Federal Register in which FDA ...

All Drugs Approved in 2020 Met User Fee Goals: FDA

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FDA says that all 53 new molecular entity approvals in 2020 were acted on by or before their user fee goal dates.

Info Collection on FDA Recall Regulations

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Federal Register notice: FDA seeks comments on an information collection extension entitled FDA Recall Regulations 21 CFR Part 7....

FDA Hits Neoleukin with Clinical Hold on Immunotherapy

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FDA issues a clinical hold on a Neoleukin Therapeutics Phase1 clinical trial of its immunotherapeutic candidate, NL-201, requestin...

Office of Generic Drugs New Reorganization

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CDER announces that a planned Office of Generic Drugs reorganization has been approved and will be implemented later this year.

FDA Seeks Advisory Committee Consumer Reps

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Federal Register notice: FDA seeks consumer organizations interested in participating in the selection of voting and nonvoting con...

Alert on Molecular Tests Used with Covid-19 Emerging Variant

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FDA alerts clinical laboratory staff and health care providers about the potential impact of viral mutations, including an emergin...

FDA Inspection Releases Review Hold on BMS Liso-cel

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FDA continues its review of a Bristol-Myers Squibb BLA for lisocabtagene maraleucel (liso-cel), indicated for treating adults with...

Gemini Therapeutics Fast Track for Macular Degeneration Drug

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FDA grants Gemini Therapeutics a fast track designation for GEM103, an investigational treatment for dry, age-related macular dege...

FDA Debars Insys Sales Manager

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Federal Register notice: FDA issues an order to permanently debar former Insys Therapeutics regional sales manager Joseph A. Rowan...