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# Opportunities for Drug Development Dynamic Tools
- URL: https://www.fdaweb.com/opportunities-for-drug-development-dynamic-tools/
- Published: 2025-03-06T12:00:00.000Z
- Updated: 2026-09-14T14:54:41.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158776

Participants at a 5/2-5/3/2024 public discussion hosted by FDA and the Center for Research on Complex Generics on “Pathways for Regulatory Acceptance of Dynamic Tools in the New Drug Space” found that model-based approaches like physiologically-based pharmacokinetics and population pharmacokinetics, when validated for their context of use, can serve as regulatory assets by facilitating efficient drug development. An FDA report on the workshop was [published](https://link.springer.com/article/10.1007/s11095-025-03831-5?ref=fdaweb.com) in *Pharmaceutical Research*.

“The broader potential for reusing validated models across multiple programs including Fit-For-Purpose and Model Master File present significant opportunities and complementary benefits for improving regulatory efficiency and decision-making,” the report says. It says the workshop underscored the importance of clear regulatory pathways and structured frameworks for the consistent application of reusable models.