FDA 483 - Alison R. Sehgal, MD - December 29, 2020

An FDA inspection of Alison R. Sehgal, MD, a clinical investigator in Pittsburgh, revealed a significant deviation from an investigational plan. The firm failed to conduct a required repeat bone marrow assessment for a subject with known bone marrow involvement, despite reporting a complete response. This indicates a failure to adhere to established protocol for confirming treatment efficacy.