Assistant Commissioner for Medical Products and Tobacco Operations - Office of Regulatory Affairs
Dr. Elizabeth Miller rejoined the Food and Drug Administration in March 2020 as the Assistant Commissioner for Medical Products and Tobacco Operations in the Office of Regulatory Affairs (ORA). In this role, Dr. Miller provides leadership and managerial direction to ORA’s Office of Biologics Products Operations, Office of Pharmaceutical Quality Operations, Office of Medical Device and Radiological Health Operations, Office of Bioresearch Monitoring Operations, and the Tobacco Operations Staff.
Prior to assuming her current position, Dr. Miller was the Vice President for U.S. Public Policy & Regulatory Affairs at U.S. Pharmacopeia (USP), where she worked closely on FDA regulatory issues and was responsible for helping develop and achieve USP’s regulatory science and intelligence, government affairs, and public policy programs’ goals. She also created strategic change initiatives focused on impacts and results based on engagement with federal, state, and international regulators, as well as senior leadership in industry, academia, and patient-focused alliances.
Before assuming that position with USP in in 2016, Dr. Miller worked in the FDA’s Center for Drug Evaluation and Research (CDER) in 2007 in the Office of Unapproved Drugs and Labeling Compliance (OUDLC). She began her work at CDER working on online pharmacy and health fraud issues and ultimately served as the director for OUDLC’s Division of Nonprescription Drugs & Health Fraud.
Prior to her initial time at the FDA, Dr. Miller worked at USP as a scientific liaison on medication safety standards for nomenclature, labelling, and packaging, and as the director of drug information for the USP Drug Information publication. She began her pharmacy career as a clinical pharmacist at MedStar Washington Hospital Center in Washington D.C.
Dr. Miller holds a bachelor’s degree in biology from The Johns Hopkins University and a Doctor of Pharmacy degree from the University of Maryland.