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Dr. Sabine S. Hazan, operating as President of Topelia Therapeutics, failed to comply with federal regulations governing the conduct of clinical drug investigations during FDA's inspection of her clinical site in September 2021. The primary violation involved her failure to ensure that an Institutional Review Board (IRB) compliant with 21 CFR part 56 conducted initial and continuing review and approval of proposed clinical studies, as required under 21 CFR 312.66. This deficiency in IRB oversight represented a fundamental breach of protections designed to safeguard the rights, safety, and welfare of human research subjects participating in multiple clinical protocols under her direction.