FDA 483 - Emily K. Curran, M.D. - June 03, 2022

An FDA inspection of Emily K. Curran, M.D. in Cincinnati, OH, revealed significant deviations from the investigational plan and signed statement of investigator. The firm failed to properly manage investigational product dosing for two subjects in sub-studies. One subject continued treatment despite protocol-mandated holds due to adverse lab results, and another received an incorrect dose level for multiple cycles.