Dr. Laurie Muldowney serves as the Deputy Director of the Office of Scientific Investigations (OSI) in the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration. In this role, she manages the development and implementation of patient focused, risk-based inspection, compliance, and enforcement activities under the Agency Bioresearch Monitoring Program. This includes overseeing the enforcement of clinical and non-clinical drug product studies, bioequivalence studies, human subject protections, post-market adverse drug experience reporting requirements, risk evaluation and mitigation strategies, and post marketing requirements. Before joining OSI in 2019, Dr. Muldowney served in multiple positions across CDER, including clinical team leader with the Office of New Drugs and associate director for medical policy in the Office of Translational Science. Dr. Muldowney received a B.S. in chemistry from the College of William and Mary and earned her medical doctorate from Jefferson Medical College in Philadelphia, PA. Following additional postgraduate training, Dr. Muldowney served as a primary care physician with the United States Navy.
