FDA Remote Regulatory Assessment Results in Warning Letter for MIT IRB

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FDA Remote Regulatory Assessment Results in Warning Letter for MIT IRB

J.W. Schomisch

July 19, 2024 at 12:27 PM EST

The FDA sent a Warning Letter to the Massachusetts Institute of Technology (MIT) as the result of a Remote Regulatory Assessment (RRA). The June 21 Warning Letter from the FDA Center for Biologics Evaluation and Research alleged the MIT Committee on the Use of Humans as Experimental Subjects Institutional Review Board (IRB) failed to ensure information given to subjects as pa... Read More

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FDA Remote Regulatory Assessment Results in Warning Letter for MIT IRB

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