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Dr. Peter Michael was cited for violations of clinical investigation requirements under 21 CFR 312 during an FDA inspection of his clinical site conducted in June 2024. The primary violation involved failure to ensure that investigational drug studies were conducted according to their approved protocols, specifically regarding the administration of an investigational drug to pediatric autism spectrum disorder subjects according to the protocol's prescribed 8-week treatment regimen. The inspection, part of FDA's Bioresearch Monitoring Program, identified objectionable conditions related to the protection of human subjects' rights, safety, and welfare in the conduct of these clinical investigations.