CDRH Sends Warning Letter for Myriad of Alleged Trial Problems

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CDRH Sends Warning Letter for Myriad of Alleged Trial Problems

J.W. Schomisch

March 18, 2024 at 11:18 AM EST

The Center for Devices and Radiological Health (CDRH) sent a Warning Letter to Nobles Medical Technology II, Inc. alleging the company failed to ensure proper monitoring and Institutional Review Board (IRB) review and approval and to select qualified investigators and monitors. The Warning Letter, which was posted on the FDA website March 12, stemmed from an October 2023 Bior... Read More

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CDRH Sends Warning Letter for Myriad of Alleged Trial Problems

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