FDA Sends Warning Letters to Investigator, IRB

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FDA Sends Warning Letters to Investigator, IRB

J.W. Schomisch

November 5, 2024 at 09:08 AM EST

The FDA sent an Oct. 10 Warning Letter to a California clinical investigator alleging she failed to follow trial protocol, obtain legally effective informed consent (IC), or prepare and maintain adequate and accurate case histories. The letter also alleged Namita Goyal, M.D., of Orange, Calif., failed to assure institutional review board (IRB) review and approval of a study me... Read More

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FDA Sends Warning Letters to Investigator, IRB

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