Investigator Gets FDA Warning Letter Over Protocol Adherence

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Clinical Investigators Receive FDA Warning Letters Over Protocol Adherence

J.W. Schomisch

September 12, 2025 at 01:15 PM EST

Two clinical investigators received September Warning Letters from the FDA Center for Drug Evaluation and Research for allegedly failing to follow trial protocols. A Sept. 4 Warning Letter to Dr. Shirish Gadgeel alleged the investigator failed to follow the protocol and failed to obtain informed consent from trial subjects. The letter was the result of a Bioresearch Monitorin... Read More

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Clinical Investigators Receive FDA Warning Letters Over Protocol Adherence

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