Advancing Generic Drug Development: Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs - 08/27/2026

FDA’s CDER SBIA announced a virtual workshop on model-integrated evidence for generic drug development and approval on August 27, 2026. For researchers, applicants and modeling professionals, it will cover FDA submission expectations and how modeling combined with laboratory and human data supports bioequivalence.

Why it matters: FDA’s workshop links modeling and study evidence to submission structure, common assessment problems and bioequivalence evaluation.