FDA 483 - Moshe Talpaz, MD - June 17, 2021

Moshe Talpaz, MD, a clinical investigator in Ann Arbor, MI, was cited for failing to conduct an investigation in accordance with the signed investigational plan. Clinical research participants were not provided with updated consent forms detailing significant study changes, including new life-threatening risks associated with the investigational product. This failure led to a clinical hold on the study due to unreasonable risks to human subjects, and the study was subsequently terminated.