BRIEF—CDER establishes new Quantitative Medicine Center of Excellence

25 March 2024

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) today announced the new  Quantitative Medicine (QM) Center of Excellence (CoE).

QM involves the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from non-clinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care.

The goal of this CDER-wide CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across the center.

On April 25, the CDER will host a public workshop on QM and will share more about the new CoE.

To register, please visit  Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence.