Author: [AUTHOR] Published on 1/27/2023 5:00:00 AM
FDA Issues Federal Register Notice – Continuation of the MIDD Paired Meeting Program Under PDUFA VII
On January 11, 2023, the US Food and Drug Administration (FDA) announced the availability of a
Federal Register notice (FRN) detailing the continuation of the Model-Informed Drug Development (MIDD) Paired Meeting Program. This program is being conducted to fulfill FDA's performance commitment under the seventh iteration of the Prescription Drug User Fee Act (PDUFA VII) as part of the FDA User Fee Reauthorization Act of 2022. The FDA will build on the success of the MIDD Paired Meeting Pilot Program by continuing to facilitate and integrate the development and application of exposure-based, biological, and statistical models derived from preclinical and clinical data sources in drug development and regulatory review.
The FRN notes that 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 goal of the meeting discussions granted under this program is to provide advice about how specific, proposed MIDD approaches can be used in a particular drug development program. For each meeting request granted as part of the paired meeting program, FDA will conduct an initial and follow-up meeting on the same drug development issues. The MIDD program will be jointly administered by the Office of Clinical Pharmacology (in the Office of Translational Sciences) within the Center for Drug Evaluation and Research (CDER) and the Office of Biostatistics and Pharmacovigilance within the Center for Biologics Evaluation and Research (CBER) in partnership with clinical staff at the relevant center to ensure alignment with decision makers.
Please see the FRN at:
https://www.federalregister.gov/documents/2023/01/11/2023-00389/prescription-drug-user-fee-act-of-2023-vii-meetings-program-for-model-informed-drug-development for more details such as listed eligibility criteria and procedures for participation, including how to submit a meeting request and meeting package. Learn more about the FDA’s MIDD Paired Meeting Program on the FDA MIDD Program Website:
https://www.fda.gov/drugs/development-resources/model-informed-drug-development-paired-meeting-program.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.