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# MIDD Pilot Lessons Learned
- URL: https://www.fdaweb.com/midd-pilot-lessons-learned/
- Published: 2024-03-06T12:00:00.000Z
- Updated: 2026-09-14T14:24:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156496

Four CDER Office of Translational Services researchers say a successful Model-Informed Drug Development (MIDD) pilot program started under PDUFA 6 is leading to an integration of MIDD as part of PDUFA 7\. Writing in *Clinical Pharmacology & Therapeutics*, the researchers [say](https://ascpt.onlinelibrary.wiley.com/doi/epdf/10.1002/cpt.3228?ref=fdaweb.com) the pilot enabled discussions on the use of MIDD approaches in the development of specific therapeutic products.

The pilot ran from 2018 to 2022 and committed to selecting one or two meeting requests per quarter each for CDER and CBER. Some 52 FDA/sponsor meetings were conducted for 42 meeting requests during the pilot. “The pilot program provided a unique forum for FDA and industry scientists to gain a shared understanding around model development, performance expectations, and the use of the model to address a specific issue in drug development,” the article says. “This mechanism allowed for conceptual, strategic, and technical alignment between quantitative clinical pharmacologists and other experts from FDA and industry and enabled the successful use of MIDD approaches to address important drug development issues, including dose selection optimization, therapeutic individualization, risk assessment and mitigation, preclinical to clinical translation, clinical trial design, endpoint selection, product labeling, and marketing registration.”

The authors present lessons learned from the pilot in these areas:

- leadership engagement and generating buy-in;
- staff education and fostering positive organizational culture; and
- process flexibility and ensuring transparent communication.

“With continued success and the lessons learned from the initiatives under PSUFA 6 and 7,” the researchers conclude, “we envision a future state where MIDD meeting requests are considered continually on a rolling basis to enable more timely engagement on the application of MIDD approaches in drug development programs and realize the intended potential of this novel regulatory pathway.”