Author: [AUTHOR] Published on 9/6/2024 12:00:00 AM
FDA Seeking Comments on Identifying Priority Focus Areas for Model-Informed Drug Development
On September 3, 2024, the US Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) issued a Federal Register notice, “Identifying Priority Focus Areas for Future Guidance Development and Engagement with Interested Parties in Model-Informed Drug Development; Request for Information.”
Model-Informed Drug Development (MIDD) approaches integrate exposure-based biological and statistical models derived from nonclinical and clinical data sources in drug development and decision making. Examples of MIDD approaches include quantitative methods such as population pharmacokinetic (popPK) modeling, exposure-response (E-R) modeling, physiologically based pharmacokinetic (PBPK) modeling, systems pharmacology/mechanistic modeling, disease progression modeling, drug-trial-disease modeling and simulation, and artificial intelligence/machine learning (AI/ML) approaches. These approaches can help assess the risks and benefits of drug products, contribute to the evidentiary framework for efficacy and/or safety, and optimize dosing regimens for patients, among other applications.
This notice establishes a public docket seeking substantive comments from interested parties on how to increase application of established MIDD approaches in regulatory decision making, identify how emerging MIDD approaches are being incorporated within drug product development, and identify opportunities to enhance interactions with FDA when discussing MIDD approaches. Information submitted in response to this notice will be used by CDER, including by its Quantitative Medicine Center of Excellence, and CBER to assist in identifying and prioritizing potential focus areas for future policy or guidance development and engagement with interested parties.
See the FRN for additional information about this open docket, including what information to include when submitting comments. FDA welcomes your comments to the public docket (Docket No. FDA-2024-N-3904) until November 4, 2024. Additional details on how to comment can be found at the Federal Register notice.
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This communication was prepared by Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.
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