FDA 483 - Timothy F. Burns, MD, PhD - September 07, 2023

An FDA inspection of Timothy F. Burns, MD, PhD, a clinical investigator in Pittsburgh, PA, revealed significant deviations from the investigational plan. The firm failed to follow the study protocol regarding investigational product dose adjustments, performance of required safety tests, and timely reporting of serious adverse events. These findings indicate a lack of adherence to clinical trial protocols.