comments last updated: September 3, 2024
In the WeedsDocument ID FDA-2024-N-3904-0001
Federal Register ID 2024-19712
Docket ID FDA-2024-N-3904
Want to get even more in the weeds?
Explore supplementary materials on regulations.govThe 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