Two Investigators Receive Warning Letters Over Trial Concerns

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Two Investigators Receive Warning Letters Over Trial Concerns

J.W. Schomisch

October 7, 2023 at 03:52 PM EST

The FDA sent Warning Letters to two Florida-based clinical investigators at the end of September alleging problems with how they conducted clinical trials. On Sept. 20, clinical investigator Luis Javier Pena-Hernandez, M.D., in Atlantis, Fla. received a Warning Letter for continuing a study after the institutional review board (IRB) approval had lapsed. He also was cited for ... Read More

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Two Investigators Receive Warning Letters Over Trial Concerns

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