Clinical Investigator Receives Warning Letter Over Alleged Failure To Follow Protocol

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Clinical Investigator Receives Warning Letter Over Alleged Failure To Follow Protocol

J.W. Schomisch

September 6, 2023 at 12:25 PM EST

The FDA sent a Warning Letter to a clinical investigator for allegedly failing to conduct a clinical investigation according to the investigational plan (21 C.F.R. §312.60). Specifically, a routine Bioresearch Monitoring inspection conducted between Sept. 1 and 22, 2022, of two studies conducted by Dr. Angela M. Stupi, Cranberry Township, Pennsylvania, allegedly revealed two ... Read More

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Clinical Investigator Receives Warning Letter Over Alleged Failure To Follow Protocol

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