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 FDA | CDER | Small Business and Industry Assistance
FDA Virtual Workshop: Leveraging MIE in Generic Drug Development
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Virtual Workshop
Advancing Generic Drug Development:
Leveraging Model-Integrated Evidence (MIE) in the Development & Approval of Generic Drugs
Time: Thursday, August 27, 2026
8:30 a.m. to 12:30 p.m. (EDT)
This virtual event is FREE!
Are you looking to deepen your understanding of FDA's regulatory expectations for Model-Integrated Evidence (MIE) and innovative quantitative modeling approaches for generic drug development and approval? This half-day virtual workshop brings together FDA experts to address regulatory challenges and explore the latest scientific advancements shaping the use of MIE to support the development and approval of generic drug products.
Attendees at this workshop will have an opportunity to pose questions to FDA experts, gain valuable insights into FDA's regulatory expectations for MIE submissions, learn practical strategies for avoiding common pitfalls, and hear real-world case studies demonstrating how MIE has successfully supported FDA guidance development and generic drug approvals.
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