Director, Office of Nonprescription Drugs, Office of New Drugs, CDER
US Food and Drug Administration
Dr. Theresa Michele is the Director of the Office of Nonprescription Drugs (ONPD) in the Office of New Drugs, Center of Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). Prior to joining FDA, she spent 10 years in industry, with clinical research experience across a variety of therapeutic areas in both commercial and development stage companies. Dr. Michele left industry in 2007 to join the FDA in the Division of Pulmonary and Allergy Drug Products, before becoming Director of the Division of Nonprescription Drug Products. She is board certified in internal medicine, pulmonary medicine, and critical care medicine, completing her training at Johns Hopkins University, where she currently serves on the faculty. She obtained her BS in Integrated Life Sciences from Kent State University and MD from Northeastern Ohio Universities College of Medicine (now Northeast Ohio Medical University) as part of a 6-year combined program.
Wednesday, September 16, 2020
12:05 PM – 1:00 PM EDT