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Wayne chats with Dr. Ritu Nalubola, Director of Life Sciences and Healthtech at Marwood Group and former FDA leader, spanning several roles over more than two decades. Together, they discuss how deregulation has been playing out at FDA; industry incentive programs, such as the Commissioner’s National Priority Voucher program and PreCheck program; how agency efforts to streamline regulation could affect product safety; how tariffs and MFN impact FDA and industry; the agency’s role in regulating AI and supporting AI applications; broader initiatives on health data and governance; Ritu’s thoughts on where things may be headed in 2026; and much more.

This episode and all bonus episodes do not include the usual Headlines and Resources Links segments.

About Our Guest

Dr. Ritu Nalubola

Dr. Ritu Nalubola spent 25 years at FDA serving in various senior leadership roles, most recently as the Associate Commissioner for Policy and the Acting Deputy Commissioner for Policy, Legislation, and International Affairs. She led the FDA’s Europe Office, as its Director, for nearly five years advancing priorities of both FDA and HHS in the region, including during COVID. Her FDA work spanned a wide range of areas as she spearheaded and advised on key policy priorities across biotechnology, digital health, nanotech, artificial intelligence, food safety and nutrition, and global regulatory cooperation. She led and contributed extensively to numerous FDA regulations and guidances throughout her tenure. Dr. Nalubola left the agency this summer to join the healthcare consulting firm, Marwood Group, and grow their life sciences and healthtech portfolio.