Phillip Kronstein, M.D. is a Team Leader for the Good Clinical Practice (GCP) Assessment Branch in the Division of Clinical Compliance Evaluation (DCCE)/Office of Scientific Investigations (OSI) at the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). In this position, Dr. Kronstein provides regulatory scientific oversight for CDER-assigned bioresearch monitoring (BIMO) activities as well as provides scientific and clinical oversight to GCP reviewers and FDA field investigators. Dr. Kronstein was previously a Senior Medical Officer in the Division of Psychiatry Products (DPP), where he managed clinical reviews of Investigational New Drugs (INDs) and New Drug Applications (NDAs).