Investigator Receives Warning Letter Over Failure To Follow Investigational Plan

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Investigator Receives Warning Letter Over Failure To Follow Investigational Plan

J.W. Schomisch

December 23, 2022 at 02:42 PM EST

The FDA sent a Dec. 14 Warning Letter to a clinical investigator for failing to ensure that a clinical investigation was conducted according to the investigational plan (21 C.F.R. §312.60). In an Oct. 18-29, 2021, Bioresearch Monitoring (BIMO) Program inspection, investigators with the FDA Center for Drug Evaluation and Research (CDER) found that clinical investigator Adarsh ... Read More

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Investigator Receives Warning Letter Over Failure To Follow Investigational Plan

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