2023-00389: Prescription Drug User Fee Act of 2023 VII Meetings Program for Model-Informed Drug Development Approaches

Summary

The seventh iteration of the Prescription Drug User Fee Act (PDUFA VII), incorporated as part of the FDA User Fee Reauthorization Act of 2022, highlights the goal of advancing model-informed drug development (MIDD). The Food and Drug Administration (FDA or Agency) is announcing the continuation of the MIDD Paired Meeting Program that affords sponsors who are selected for participation the opportunity to meet with Agency staff to discuss MIDD approaches in medical product development. Meetings under the program will be conducted by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) during fiscal years 2023-2027. This program is being conducted to fulfill FDA's performance commitment under PDUFA VII. For this program, MIDD is defined as the application of exposure-based, biological, and/or statistical models derived from non-clinical and clinical data sources to address drug development and/ or regulatory issues (see Supplementary Information, I. Background, and II. Eligibility and Selection for Participation of this notice). For each approved proposal, the program consists of two meetings between sponsors or applicants and the relevant center that provide an opportunity for drug developers and FDA to discuss the application of MIDD approaches to the development and regulatory evaluation of medical products in development.

The agency’s own summary, as published.