Investigator Receives Warning Letter Over Exclusion Criteria

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Investigator Receives Warning Letter for Allegedly Not Following Exclusion Criteria

J.W. Schomisch

May 7, 2025 at 10:49 AM EST

The FDA sent a Warning Letter to a clinical investigator alleging a failure to follow inclusion/exclusion criteria. The FDA Center for Drug Evaluation and Research sent the April 28 letter to Nana Barseghian, M.D., a clinical investigator with the Amicis Research Center in Northridge, Calif., following a routine February 2024 Bioresearch Monitoring Program clinical site inspe... Read More

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Investigator Receives Warning Letter for Allegedly Not Following Exclusion Criteria

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