FDA 483 - Evan Alley, M.D., Ph.D. - September 05, 2019

An FDA inspection of Evan Alley, M.D., Ph.D. in Philadelphia revealed a significant deviation from the investigational plan and protocol. The principal investigator failed to obtain confirmation from the blinded independent committee review (BICR) for disease progression before discontinuing subjects from study treatment. This lapse occurred in multiple instances, indicating a failure to adhere to critical study procedures.