In a Federal Register Notice published, 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 [FDA]