Karen Midthun, MD FDA

Dr. Midthun is the Director of the Center for Biologics Evaluation and Research (CBER), Food and Drug Administration. CBER regulates vaccines, allergenics, blood and blood products, and cellular, tissue, and gene therapies. Its responsibilities include oversight of the investigational phases of product development, decisions regarding licensure, and post-licensure surveillance activities. Dr. Midthun previously served as the Deputy Director of CBER and the Director of the Office of Vaccines Research and Review within CBER. Before joining the FDA in 1993, Dr. Midthun was on the faculty of the Department of International Health at the Johns Hopkins Bloomberg School of Public Health, where she was involved in the clinical development of investigational vaccines and was an attending physician at the Johns Hopkins Hospital. Dr Midthun received her bachelor’s degree from the Massachusetts Institute of Technology and her medical degree from the George Washington University School of Medicine. She trained as a resident in internal medicine at Johns Hopkins Hospital and as a fellow in infectious diseases at Johns Hopkins Hospital and the National Institute of Allergy and Infectious Diseases. She is a fellow of the Infectious Diseases Society of American and a member of the American College of Physicians.