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# FDA Enhancements Sought for Model-Informed Drug Development
- URL: https://www.fdaweb.com/fda-enhancements-sought-for-model-informed-drug-development/
- Published: 2020-10-29T12:00:00.000Z
- Updated: 2026-09-14T16:34:29.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147985

FDA is pitching a plan to enhance its Model-Informed Drug Development (MIDD) activities under the next iteration of its Prescription Drug User Fee Act (PDUFA) program, which is up for renewal 9/2022\. During a recent FDA/Industry PDUFA subgroup negotiation meeting on regulatory decision tools, the agency discussed its “interest in building upon lessons learned from PDUFA VI to create enhancements to integrate MIDD in drug development,” according to an FDA-posted meeting summary.

FDA held a workshop in 2018 on [MIDD for oncology product](https://www.fda.gov/drugs/news-events-human-drugs/fda-isop-public-workshop-model-informed-drug-development-midd-oncology-products?ref=fdaweb.com)s where it said further progress in model-informed strategies was needed to continue advancements in oncology drug development. “Innovations in clinical trial design utilizing more informative endpoints could help bring more effective treatment options to cancer patients faster by accelerating development of effective new drugs and reducing failure rates in expensive late-phase development,” the agency said. “Additionally, model-informed approaches can help satisfy a need to optimize dosing regimens for patients. Investigations to refine dosing regimens often occur after new drug approval and/or are driven by pharmacometric modeling approaches. There is growing interest in using model-informed approaches to help balance the risks and benefits of oncology products by identifying optimal dosing regimens and broad stakeholder engagement and discussion around this topic can be beneficial.”

At the recent PDUFA negotiation meeting, FDA said that based on work under the current user fee program, there is interest to ensure the “sustainability of the MIDD program, to continue public engagement, to advance regulatory acceptance of MIDD, and to keep up with the growing demand and pace of innovation.” The agency is proposing to enhance early regulatory engagement for MIDD-focused meetings, to hold more public workshops and dedicated programs to increase stakeholder engagement and education, and to “invest in a comprehensive end-to-end guidance development and implementation to ensure timely publication of contemporary MIDD guidance documents,” the meeting summary said.

FDA also told industry representatives that sustaining the MIDD program would require increased staffing. Industry asked questions about MIDD’s current operation, CBER’s participation in the program, current resource allocations, and for more information regarding the potential need for additional staffing.

The parties agreed to have a follow up discussion on potential MIDD enhancements and to discuss them in relation to complex innovative trial designs, according to the summary.