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# Quantitative Medicine Center of Excellence Created
- URL: https://www.fdaweb.com/quantitative-medicine-center-of-excellence-created/
- Published: 2024-03-25T12:00:00.000Z
- Updated: 2026-09-14T14:26:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156625

CDER has created a new Center of Excellence (CoE) for Quantitative Medicine (QM), which it says involves the “development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care.” The CoE is intended to coordinate the “consistent application of QM across CDER,” according to an [agency release](https://www.fda.gov/drugs/drug-safety-and-availability/cder-establishes-new-quantitative-medicine-center-excellence?utm%5Fmedium=email&utm%5Fsource=govdelivery), adding that it will:

- Spearhead QM-related policy development and best practices to ensure consistent use of QM approaches during drug development and regulatory assessment
- Coordinated outreach to scientific societies, patient advocacy groups, and other key stakeholders
- Focus on CDER’s QM education and training efforts

Additionally, CDER says that by integrating QM approaches across CDER it will help “advance therapeutic medical product development and inform regulatory decision-making. As a result, the QM CoE is expected to help streamline and accelerate drug development and speed the delivery of safe, effective, therapeutically optimized medicines to the public.”

It notes that through a 4/25 public workshop on QM it will share more information about the new CoE. To register, visit [*Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence*](https://www.fda.gov/drugs/news-events-human-drugs/streamlining-drug-development-and-improving-public-health-through-quantitative-medicine-introduction?ref=fdaweb.com).