CDRH Sends Warning Letter Over Significant Risk Study Concerns

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CDRH Sends Sponsor Warning Letter Over Significant Risk Study Concerns

J.W. Schomisch

May 25, 2025 at 11:15 AM EST

The FDA Center for Devices and Radiological Health (CDRH) issued a Warning Letter to the sponsor of a significant risk clinical study alleging the company failed to properly monitor the study. It is the first BIMO-related Warning Letter CDRH has issued in a year. The March 24 Warning Letter to United Health Products, Inc., in Mt. Laurel, N.J., was the result of a Bioresearch ... Read More

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CDRH Sends Sponsor Warning Letter Over Significant Risk Study Concerns

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