CBER Issues First 2025 Warning Letter for Clinical Trial Concerns

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CBER Issues First 2025 Warning Letter Addressing Clinical Trial Concerns

J.W. Schomisch

June 6, 2025 at 12:15 PM EST

The FDA’s Center for Biologics Evaluation and Research (CBER) sent its first 2025 Warning Letter regarding human research protections to a clinical investigator. CBER sent three human research protections Warning Letters in 2024, including two to clinical investigators. The March 25 Warning Letter, which was posted by the FDA on June 3, alleged clinical investigator Amy Ligh... Read More

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CBER Issues First 2025 Warning Letter Addressing Clinical Trial Concerns

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