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Guidance on CMC Flexibility for Human CGTs

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FDA publishes a guidance explaining how the agency uses a flexible chemistry, manufacturing, and controls approach to help expedit...

FDA Meeting on AI pilot for Early-Stage Clinical Trials

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FDA hosts a virtual public meeting later this month to address industry questions tied to a planned pilot program exploring the us...

Unetixs Vascular Selling Illegal Devices: FDA

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FDA warns Unetixs Vascular about illegally marketing adulterated and misbranded vascular diagnostic ultrasound devices.

FDA Stresses Sponsor Responsibility in Decentralized Clinical Trials

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FDA reaffirms support for decentralized clinical trials (DCTs) while making clear that moving trial activities outside traditional...

Makary Defends FDA Drug Decisions

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

CareFusion Hit With Warning at Texas Drug Facility

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FDA sends a Warning Letter to CareFusion, citing widespread and repeat violations of current good manufacturing practice regulatio...

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New reporting reveals that FDA has withdrawn or blocked the publication of multiple internal studies supporting the safety of Covi...