FDA 483 - Barrett E. Cowan, MD - February 05, 2019

Dr. Barrett E. Cowan, MD, a clinical investigator in Englewood, CO, was cited for significant deficiencies in conducting a Phase 3 clinical trial for Vicinium. The inspection revealed failures in adhering to the investigational plan, including enrolling ineligible subjects and not performing required safety assessments and biopsies. Additionally, the firm failed to maintain adequate case histories and properly document informed consent, including re-consenting subjects with updated IRB-approved forms.