Dr. Theresa Michele is currently 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 the FDA in the Division of Pulmonary and Allergy Drug Products, she spent 10 years in the industry, with clinical research experience across a variety of therapeutic areas in both commercial and development-stage companies. 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.