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Human Drugs

Makary Defends FDA Drug Decisions

FDA commissioner Marty Makary forcefully defends the agency against mounting criticism of recent drug rejections, arguing the agency is following the ...

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Human Drugs

CareFusion Hit With Warning at Texas Drug Facility

FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulations at a Texas facili...

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Human Drugs

FDA Hits Respilon Production for 5 CGMP Violations

FDA warns Czechias Respilon Production about CGMP violations in its manufacturing of over-the-counter drugs.

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Human Drugs

Recent Accelerated Approval Path Changes Explained

A Bioprocess Online guest column outlines recent changes to FDAs accelerated approval pathway that were made to address systemic failures in the pathw...

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Human Drugs

FDA, TransCelerate Collaborate on Streamlined Safety Data Collection

TransCelerate reports on a 2025 tabletop exercise it convened with the CDER Center for Clinical Trial Innovation that focused on streamlined safety da...

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Human Drugs

FDA Blocks Publication of Vaccine Safety Studies

New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covid-19 and shingles va...

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Human Drugs

3 CGMP Issues At Active Cosmetics Manufacturing

FDA warns Orlando, FL-based Active Cosmetics Manufacturing about CGMP violations in its production of finished drugs.

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Human Drugs

High Court Pauses Limits on Mifepristone

The U.S. Supreme Court issues a temporary pause on a 5/1 lower court ruling that would have curtailed access to the abortion pill mifepristone.

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Biologics

Scrutiny of Gene Therapy Evidence Intensifies After Recent Setbacks

An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpinning cell and gene t...

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Federal Register

Alnylam Pharmas Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a consumer-facing Web site for its drug Amvuttra.