Clinical Investigators Receive Warning Letters Over Lack of IND and Not Following Protocol

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Clinical Investigators Receive Warning Letters Over Lack of IND and Not Following Protocol

J.W. Schomisch

March 31, 2023 at 04:06 PM EST

The FDA Center for Drug Evaluation and Research issued Warning Letters to a clinical trial site and a sponsor-investigator in mid-March. In a March 21 Warning Letter, the agency alleged Tyrone McCall, M.D., a clinical investigator and sponsor representative of Tyrone L. McCall, M.D./Cornea Associates of Texas in Dallas, failed to submit an Investigational New Drug application... Read More

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Clinical Investigators Receive Warning Letters Over Lack of IND and Not Following Protocol

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