AI in generic Drug Development and Regulatory Assessment
Tuesday, October 28, 2025
1:30 p.m. - 2:45 p.m.
AI is here and is rapidly becoming a part of both industry drug development and the FDA’s regulatory assessment process. FDA recently announced the completion of its first AI-assisted scientific review pilot and an Agency-wide AI rollout timeline. This session will discuss how AI is being used in generic drug development and how FDA is using AI during application review, including benefits and challenges.
Participants:
Tao Bai, PhD
Senior Advisor, Office of Bioequivalence, OGD, FDA
Aaron Josephson, MS
Senior Director, Global Regulatory Policy, Teva Pharmaceuticals
Moderator: Robert Lionberg, PhD
Director, Office of Research and Standards (ORS), OGD, CDER, FDA
