FDA Sends Investigator Warning Letter Over Informed Consent

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FDA Sends Investigator Warning Letter Over Informed Consent

J.W. Schomisch

January 31, 2025 at 10:20 AM EST

The FDA’s Center for Drug Evaluation and Research (CDER) sent a clinical investigator a Jan. 17 Warning Letter alleging a failure to obtain informed consent. According to the letter, Americo Padilla, M.D., with the Miami Dade Medical Research Institute in Miami, failed to obtain legally effective written consent from two subjects before their enrollment in a protocol because ... Read More

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FDA Sends Investigator Warning Letter Over Informed Consent

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