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Vasisht Named Associate Commissioner for Womens Health

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FDA names Kaveeta Visisht to be associate commissioner for womens health.

CGMP Violations at Lohxa LLC

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FDA warns Lohxa LLC about CGMP violations in its production of finished pharmaceuticals.

Device-Related Infections Likely Antibiotic-Resistant: Study

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A Center for Disease Control and Prevention report says that healthcare-associated infections resulting from medical devices are m...

CymaBay Stops Seladelpar Studies Over Safety Concerns

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CymaBay Therapeutics terminates a Phase 2b study of seladelpar in subjects with non-alcoholic steatohepatitis and its recently ini...

FDA Reopens Tobacco Product Comment Period

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Federal Register notice: FDA reopens for 20 days the comment period on a 9/25 proposed rule on premarket tobacco product applicati...

Intercept NDA for NASH Drug Accepted

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FDA accepts for priority review an Intercept Pharmaceuticals NDA for obeticholic acid seeking accelerated approval for treating fi...

Draft Guide on Certificates of Confidentiality

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Federal Register notice: FDA has made available a draft guidance entitled Certificates of Confidentiality; Guidance for Sponsors, ...

New FDA Efforts on Device EtO Sterilization

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FDA announces its Ethylene Oxide Sterilization Master File Pilot Program that is intended to allow companies that sterilize single...

FDA Guidances for Generic Drug Developers

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Federal Register notice: FDA makes available additional draft and revised draft product-specific guidances for generic drug develo...

Info Collection for Fellowship/Trainee Programs

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Federal Register notice: FDA seeks comments on a proposed information collection for Collection of Information for Participation i...