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# Pilot on ANDA Model-Integrated Evidence
- URL: https://www.fdaweb.com/pilot-on-anda-model-integrated-evidence/
- Published: 2023-10-02T12:00:00.000Z
- Updated: 2026-09-14T18:59:45.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155458

CDER’s Office of Generic Drugs has launched a new pilot program to offer meeting opportunities to generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) determinations in their ANDAs. “The use of MIE approaches for BE establishment is increasingly prevalent, particularly in the development of challenging products, such as long-acting injectables, orally inhaled drugs, and topically applied dermatological products,” an [agency notice](https://www.fda.gov/drugs/abbreviated-new-drug-application-anda/model-integrated-evidence-mie-industry-meeting-pilot-between-fda-and-generic-drug-applicants?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. "Industry regularly seeks FDA guidance on best practices for implementing MIE, including common model approaches and addressing complex scientific and regulatory issues.”

FDA says the pilot’s primary goal is to foster early and focused interactions between industry and agency reviewers on science-driven topics related to MIE approaches for establishing BE in generic drug development. It will focus the scientific communication on employing quantitative methods and modeling techniques. It will also:

- address common issues across multiple products and complex issues for non-complex products that fall outside the scope or focus of current pre-ANDA and ANDA meetings, and
- provide a dedicated platform for in-depth discussions on scientific and technical matters related to MIE implementation

The agency says it will continue to receive meeting requests under the pilot until a sufficient number of MIE meetings are held. It will evaluate the pilot at the end of year one or after five meetings have been held, whichever comes first, to determine the program’s next phase.