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 FDA | CDER | Small Business and Industry Assistance
INDUSTRY NEWS
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Comments Requested: Use of a Type V Drug Master File for Model Master File Submissions to Support Abbreviated New Drug Applications
In a Federal Register Notice published today, FDA announced the establishment of a public docket and request for comments regarding the use of a Type V drug master file (DMF) for model master file (MMF) submissions to support abbreviated new drug applications (ANDAs).
FDA recognizes the evolving role model-integrated evidence (MIE) plays in generic drug development and other regulatory applications, as well as industry’s desire for an improved framework for in silico model-sharing, model acceptance, communications with the agency. Using the Type V DMF to efficiently leverage MMFs within the scope of successful MIE approaches (such as supporting alternative bioequivalence (BE) approaches or biowaivers) may help advance generic drug development and facilitate the ANDA assessment and approval processes. For example, use of the Type V DMF for MMF submissions to support ANDAs will allow DMF holders to authorize one or more ANDA applicants to incorporate by reference information and data comprising an MMF without having to disclose that information and data to the applicant(s).
FDA has opened the comment docket to solicit feedback from interested parties on the use of a Type V DMF for MMF submissions to support ANDAs. Questions about the Notice or MMFs may be directed to MMF@fda.hhs.gov.
Related Resources
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Upcoming SBIA Webinar: Model Master Files: Advancing Modeling and Simulation in Generic Drug Development and Regulatory Submissions On March 13, 2025, FDA will hold a session providing an update on FDA’s efforts related to MMFs. Following presentations, FDA staff will engage in a panel discussion followed by a Q&A session. Please visit the webinar web page for more information.
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Presentation Recordings In May 2024, FDA and the Center for Research on Complex Generics held a related workshop, Considerations and Potential Regulatory Applications for a Model Master File. This event convened model developers, industry, and FDA in a discussion on the concept, scope, and regulatory application of MMFs. Full presentation recordings are available on the workshop web page.
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The Small Business and Industry Assistance (SBIA) program in the Center for Drug Evaluation and Research provides guidance, education and updates for regulated industry.
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