Brian J. Hasselbalch

FDA/CDER/OPQ/OPPQ
Deputy Director (Acting), Office of Policy for Pharmaceutical Quality
Brian Hasselbalch is currently acting Deputy Director in FDA’s Office of Policy for Pharmaceutical Quality (OPPQ) in CDER’s Office of Pharmaceutical Quality. He helps direct the office responsible for the development and implementation of regulations, guidance, and programs governing the quality ‘lifecycle’--pre-market through commercialization. These policies and programs impact all pharmaceuticals for human use and are to ensure US patients have access to high quality pharmaceuticals. Mr. Hasselbalch has been with FDA since 1990, when he began his career in FDA’s San Francisco District Office inspecting drug operations in California and overseas. He transferred to CDER in 1995 to work on enforcement actions, international mutual reliance arrangements, and drug quality policies. Mr. Hasselbalch led the team that designed and implemented the first risk-based model to prioritize sites for inspection, revised several pharmaceutical inspection programs, proposed and coordinated FDA’s application to the Pharmaceutical Inspection Cooperation Scheme, led the group that developed the framework for the “concept of operations” between CDER and ORA, and contributed to the development and implementation of the US-EU MRA.