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Dr. Mark J. Savant failed to conduct a clinical investigation in accordance with FDA regulations governing drug studies and human subject protection, as determined during an April 2024 inspection of his clinical site. Specifically, he did not adhere to the investigational plan for Protocol (b)(4), failing to properly calculate investigational product volumes based on subjects' body weight and neglecting to verify that subjects met eligibility requirements before enrollment. These violations contravened 21 CFR 312.60 and other applicable provisions of the Federal Food, Drug, and Cosmetic Act governing clinical investigations.