Elizabeth Miller

Elizabeth Miller, Pharm.D.

Asst Commissioner Medicals Products & Tobacco Ops


Dr. Elizabeth Miller rejoined the US FDA in March 2020. In her role as the assistant commissioner for medical products and tobacco operations, 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. Dr. Miller returned from the U.S. Pharmacopeia (USP) where she helped guide USP’s working relationship with the FDA. At USP, Dr. Miller was vice president, US public policy & regulatory affairs, with responsibility to deliver executive leadership for developing and achieving USP’s US regulatory science and intelligence, government affairs and public policy programs’ goals. She also created strategic change focused on impacts and results resulting from engagement with federal, state, and international regulators, as well as senior leadership in industry, academia and patient-focused alliances.



Keynote Address — The FDA Perspective on Inspections: What’s Happening Now and What to Expect in 2023