Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions

March 13, 2025

This event provides an update on FDA’s efforts related to model master files (MMFs). The agenda includes presentations by FDA staff that will focus on an introduction and overview of MMFs, considerations for developing and submitting MMFs to support ANDAs using a Type V DMF, and a cross-comparison to other types of DMFs, including lessons learned.

Intended Audience

This webinar is designed for members of the generic drug industry, including:

• Current and potential holders and applicants of abbreviated new drug applications (ANDAs) who are interested in using modeling and simulation to support their applications
• Prospective drug master file (DMF) holders
• Regulatory reviewers for generic drug development and assessments
• Industry consultants focused on bioequivalence approaches
• Clinical research coordinators and foreign regulators

Topics Covered

• Describe the purpose, benefits, and challenges of MMFs
• Understand how to navigate the process for using the Type V DMF for MMF submissions to support ANDAs
• Recognize the value MMFs provide to the development, assessment, and approval of high-quality generic drugs
• Implement best practices for MMF submissions in your work

Resources

• Federal Register Notice: Establishment of a Public Docket: Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications
• Model-Integrated Evidence (MIE) Industry Meeting Pilot Between FDA and Generic Drug Applicants

visit the FDA.gov webpage