FDA Warning Letter Cites Investigator Over Subject Eligibility and Case Histories

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FDA Warning Letter Cites Investigator Over Subject Eligibility and Case Histories

J.W. Schomisch

November 6, 2023 at 09:18 AM EST

A clinical investigator received an Oct. 20 FDA Warning Letter for allegedly failing to properly follow protocol eligibility requirements and to maintain adequate and accurate case histories. The Warning Letter to Maria Greenwald, M.D., a clinical investigator in Palm Desert, Calif., resulted from an Oct. 17 and Oct. 27, 2022, Bioresearch Monitoring program inspection. The W... Read More

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FDA Warning Letter Cites Investigator Over Subject Eligibility and Case Histories

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