FDA’s generic drug program has launched a new pilot program to offer meeting opportunities to prospective generic drug applicants and generic drug applicants who intend to use model-integrated evidence (MIE) approaches for bioequivalence (BE) establishment in their abbreviated new drug applications (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. Industry regularly seeks FDA feedback on best practices for implementing MIE, including common model approaches and addressing complex scientific and regulatory issues.
The primary goal of the MIE Pilot Program is to foster early and focused interactions between industry and FDA on science-driven topics related to MIE approaches for establishing BE in generic drug development. The pilot will facilitate enhanced scientific communication between generic drug developers and FDA, with a specific focus on employing quantitative methods and modeling techniques. The new MIE pilot program intends to:
- 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 in the product development cycle, preferably at the early stage of the program.
Under the MIE Pilot Program, a meeting may be granted if it pertains to:
- innovative MIE-focused approaches for BE establishment that cannot be effectively addressed under the existing GDUFA scientific meetings,
- non-complex products with complex approaches/modeling for Biopharmaceutics Classification System (BCS)--based biowaivers and/or other study waivers, and
- novel data analytics tools and approaches (e.g., machine learning and artificial intelligence) for BE establishment and assessment.
Overall, the pilot program serves as a specialized regulatory platform for industry to explore the proposed MIE approaches, obtain FDA’s advice on their feasibility and advancement, and address relevant scientific and technical questions.
FDA’s Office of Generic Drugs will begin receiving meeting requests for the pilot program on October 1, 2023. FDA will continue to receive meeting requests under the MIE pilot program until a sufficient number of MIE meetings are held. FDA will evaluate the pilot program at the end of year one or after five meetings have been held--whichever occurs first--to determine the next phase of the pilot program.
Refer to the General Principles document for details on the MIE pilot meeting process.
Questions about the program may be directed to MIE@fda.hhs.gov.
