Patrizia Cavazzoni, M.D., is the director of the Center for Drug Evaluation and Research (CDER) at the U.S. Food and Drug Administration. The Center’s mission is to ensure that safe, effective and high-quality drugs are available to the public. To achieve this, CDER regulates the medical products under its jurisdiction throughout their lifecycle, oversees the development of new and generic drugs, evaluates applications to determine whether drugs should be approved, monitors the safety of drugs after they are marketed, conducts research to advance regulatory science and takes enforcement actions to protect the public from harmful products. Dr. Cavazzoni joined the FDA in January 2018 as CDER’s Deputy Director for Operations where she has led several key initiatives on behalf of the organization. She also served as Acting Principal Deputy Commissioner of Food and Drugs from January 2019 to February 2019. Dr. Cavazzoni received her medical degree at McGill University and completed a residency in psychiatry and a fellowship in mood disorders at the University of Ottawa. During her training, she was an investigator in clinical trials of novel antipsychotic and antidepressant medications and became a research collaborator within the International Group for The Study of Lithium Treated Patients. She subsequently received a full-time appointment to the Faculty of Medicine at the University of Ottawa, and joined the Mood Disorders Program at the Royal Ottawa Hospital, where she treated patients suffering from severe mood disorders, taught students and conducted research on genetic predictors of bipolar disorder as part of a multidisciplinary international collaborative effort, authoring numerous peer-reviewed scientific publications. After her tenure in academic medicine, Dr. Cavazzoni worked in the pharmaceutical industry for several years and held senior executive positions in clinical development, regulatory affairs, and safety risk management in large companies across multiple therapeutic areas, until she joined the FDA. Dr. Cavazzoni obtained certification by the American Board of Neurology and Psychiatry in 1997 and 2008 and is a fellow of the Canadian Royal College of Physician and Surgeons. She is a fellow of the Canadian College of Neuropsychopharmacology and a recipient of the American College of Psychiatrists’ Laughlin Fellowship.