FDA 483 - Diwakar Davar, M.D. - October 19, 2023

Diwakar Davar, M.D., a Sponsor-Investigator in Pittsburgh, PA, was cited for significant deficiencies related to Institutional Review Board (IRB) oversight during clinical studies. The inspection revealed that research activities continued during a lapse in IRB approval and that changes to a study protocol were implemented without prior IRB approval. These findings indicate a failure to ensure proper ethical and regulatory review of clinical research.