The Food and Drug Administration (FDA or Agency) is announcing a pilot program that affords sponsors or applicants who are selected for participation the opportunity to meet with Agency staff to discuss model-informed drug development (MIDD) approaches in medical product development. Meetings under the pilot 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 2018 to 2022.
This pilot program is being conducted to fulfill FDA’s performance commitment under PDUFA VI. For this pilot program, MIDD is defined as the application of exposure-based, biological, and/or statistical models derived from preclinical 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 pilot program consists of two meetings between sponsors or applicants and the relevant center and will 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.
To read the published document by the FDA and to register, click here .