Identifying Priority Focus Areas for Future Guidance Development and Engagement With Interested Parties in Model-Informed Drug Development; Request for Information
Summary

The Center for Drug Evaluation and Research CDER and Center for Biologics Evaluation and Research CBER within the Food and Drug Administration FDA or Agency are announcing a request for information RFI for advancing model-informed drug development MIDD. The purpose of this request is to obtain feedback on how to increase application of established MIDD approaches in regulatory decision making to identify how emerging MIDD approaches are being incorporated within drug product development and to identify opportunities to enhance interactions with FDA when discussing MIDD approaches. We intend to use the information submitted in response to this request to identify and prioritize potential focus areas for future policy or guidance development and enhance engagement with interested parties including interactions as part of the