Michael
Davis,
M.D., Ph.D.
Leadership Role
Acting
Center Director - Center for Drug Evaluation and Research (CDER) - Food and Drug Administration
Michael Davis, M.D., Ph.D., is the Acting Center Director of the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (CDER). CDER’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 – overseeing the development of new and generic drugs, evaluating applications to determine whether drugs should be approved, monitoring the safety of drugs after they are marketed, conducting research to advance regulatory science, and taking enforcement actions to protect the public from harmful products.
Dr. Davis was previously the Deputy Center Director of CDER, serving on the senior leadership team supporting the Center Director by providing executive leadership on strategic initiatives that advanced CDER's mission.
Dr. Davis completed a Medical Scientist Training Program (M.D., Ph.D. in pharmacology) at Case Western Reserve University, psychiatric residency training at the Semel Institute for Neuroscience and Human Behavior at UCLA, and a clinical research fellowship at the West Los Angeles VA Mental Illness Research, Education, and Clinical Center. His research interests focused on the development of novel therapeutics for schizophrenia. Following completion of his fellowship in 2014, he was a Staff Psychiatrist at the Michael E. DeBakey VA Medical Center in Houston, TX, and an Assistant Professor in the Baylor College of Medicine Department of Psychiatry and Behavioral Sciences. Dr. Davis is licensed to practice medicine and is board certified in psychiatry.
From 2016–2022, Dr. Davis served in CDER’s Office of New Drugs (OND) as a Clinical Team Leader in the Division of Psychiatry, where he led multidisciplinary teams in the review of drugs for the treatment of psychiatric disorders, as well as contributed to regulatory science and policy development. In this role, he received numerous honors and awards, including the Division of Psychiatry Annual Awards for Individual Supervisor and for Collaboration, and the FDA Outstanding Service Award for leadership in advancing science in psychiatric drug development. Dr. Davis also presented nationally and internationally on regulatory topics such as estimands, digital health technologies, and issues related to development of psychedelic-based therapies. After leaving the agency in 2022, Dr. Davis served from 2022-2025 as Chief Medical Officer for a nonprofit medical research organization developing psychedelic drugs for the treatment of major depressive disorder and post-traumatic stress disorder. In 2025, Dr. Davis returned to the agency.