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FDA Hits Respilon Production for 5 CGMP Violations

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

Recent Accelerated Approval Path Changes Explained

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A Bioprocess Online guest column outlines recent changes to FDAs accelerated approval pathway that were made to address systemic f...

FDA, TransCelerate Collaborate on Streamlined Safety Data Collection

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

FDA Blocks Publication of Vaccine Safety Studies

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New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covi...

3 CGMP Issues At Active Cosmetics Manufacturing

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

High Court Pauses Limits on Mifepristone

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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 ...

Scrutiny of Gene Therapy Evidence Intensifies After Recent Setbacks

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An opinion article notes that recent FDA regulatory decisions are leading to a sharper focus on the evidentiary standards underpin...

Alnylam Pharmas Web Promo is Misleading: FDA

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

Bayer DTC Materials Run Afoul of FDA

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FDA issues an untitled letter to Bayer HealthCare Pharmaceuticals, citing misleading direct-to-consumer advertising for its prosta...

Makary Outlines Sweeping Reforms to Speed Drug Development

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FDA commissioner Marty Makary outlines his goals to overhaul how the agency reviews new drugs, aiming to reduce early-stage regula...