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Talk to a SpecialistTalk to a SpecialistDr. Jeffrey W. Taub at Children's Hospital of Michigan failed to conduct clinical drug investigations in accordance with FDA regulations governing the protection of human subjects in research. FDA inspectors found that Dr. Taub did not ensure his clinical studies were conducted according to their investigational plans, violating 21 CFR 312.60 and other applicable requirements under the Federal Food, Drug, and Cosmetic Act. The violations were identified during an FDA Bioresearch Monitoring Program inspection conducted between September and October 2022 at the clinical site.