FDA 483 - Jeffrey W. Taub, M.D. - October 12, 2022

Jeffrey W. Taub, MD, Clinical Investigator, in Detroit, MI, was cited for significant issues during an FDA inspection. The investigation was not conducted according to the investigational plan, specifically regarding failures in the informed consent process and a participant receiving unauthorized additional study treatment. Additionally, there were failures to ensure IRB compliance, leading to lapses in study approval for multiple protocols.