Elizabeth Miller, Pharm.D., is the Assistant Commissioner for Medical Products and Tobacco Operations. She leads the Office of Regulatory Affairs’ (ORA) 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, which are all part of ORA’s Office of Medical Products and Tobacco Operations (OMPTO).
Most recently, Dr. Miller served as vice president for U.S. Public Policy & Regulatory Affairs at U.S. Pharmacopeia (USP), where she helped guide USP’s relationship with the FDA. She provided executive leadership to develop and achieve USP’s regulatory science and intelligence, government affairs, and public policy programs’ goals. Dr. Miller also strategized USP’s impacts and results, which stemmed from engaging with federal, state, and international regulators, industry leaders, academia, and patient-focused alliances.
Before rejoining USP, Dr. Miller began her federal career with the FDA’s Center for Drug Evaluation and Research (CDER) in the Office of Unapproved Drugs and Labeling Compliance (OUDLC). At CDER, she worked on online pharmacy and health fraud issues and became the director for OUDLC’s Division of Nonprescription Drugs and Health Fraud.
Prior to federal service, 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 started her pharmacy career working as a clinical pharmacist at MedStar Washington Hospital Center in Washington, D.C.
Dr. Miller received a bachelor’s degree in biology from Johns Hopkins University in Maryland and earned a Doctor of Pharmacy degree from the University of Maryland.