Investigator Is Issued Warning Letter Over Randomization Concerns

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Investigator Is Issued Warning Letter Over Randomization Concerns

J.W. Schomisch

November 21, 2023 at 12:59 PM EST

A clinical investigator in Tennessee was issued an FDA Warning Letter after a routine bioresearch monitoring (BIMO) inspection allegedly revealed that six subjects were randomized into trials without satisfying laboratory test requirements. Dr. Melanie Hoppers, the founder and chief medical officer of Physicians Quality Care in Jackson, Tennessee, was issued the Nov. 8 Warnin... Read More

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Investigator Is Issued Warning Letter Over Randomization Concerns

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