Member
Barr Consulting LLC
John "Barr" Weiner recently retired early from FDA, stepping down from his final role as Director of FDA's Office of Global Operations. There, he was responsible for the Agency's foreign offices in China, Europe, India, and Latin America, fostering and managing bilateral and regional G2G relationships, and engaging other interested parties worldwide, across commodities to address strategic issues for FDA (e g., clinical trial modernization, data access and integrity, AI use and oversight, inspectional policies and capacity, supply chain/shortage, regulatory collaboration and reliance).
Prior to leading OGO, Mr. Weiner served as Associate Director for Policy in FDA's Office of Combination Products. There he played a leading role in the development and implementation of FDA's combination products regulatory program, working with counterparts and industry from around the world to foster consistent, efficient, risk-based regulation and best practices for these products.
Mr. Weiner is a lawyer, who began his career at FDA as an Associate Chief Counsel in FDA's Office of Chief Counsel, focused on drugs and cross-cutting topics such as IP and market access for drugs and FDA's regulatory approach to nanotechnology. He began his legal career in private practice, focusing on food and drug, environmental, and related areas of trade and public international law.
Currently, Mr. Weiner is providing strategic advice and support to regulated entities through his recently formed consultancy, Barr Consulting LLC.
Global Harmonization in the Diverging Combination Products Space
Thursday, November 13, 2025
10:20 AM - 11:20 AM East Coast USA Time