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Clinical Pharmacology Corner

THE RIGHT TREATMENT | FOR THE RIGHT PATIENT | AT THE RIGHT TIME | EVERY TIME

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)

Join via Adobe Connect: Click Here to Register.
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.

Topics

• An overview of MIE submissions received by FDA and key takeaways for the field.
• Up-to-date regulatory expectations and lessons learned for population pharmacokinetics (popPK) modeling, locally-acting physiologically based pharmacokinetic (PBPK) modeling, and oral PBPK modeling in generic drug submissions.
• The role of MIE in shaping FDA product-specific and general guidance development across a range of drug products, including orally inhaled drug products, long-acting injectables, ophthalmic drug products, and oral drug products.
• An update on the ICH M15 guidance on “General Principles for Model-Informed Drug Development”.

Audience

Scientists, researchers, current and prospective generic drug applicants, regulatory affairs professionals, and modelers who work on or have an interest in the development of generic drugs products.

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We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov.