The FDA Center for Drug Evaluation and Research (CDER) Small Business and Industry Assistance (SBIA) invites attendees to a special upcoming event providing 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. Following the presentations, FDA staff will engage in a panel discussion in addition to a Q&A session.

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