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Regulatory Intel
April 05 2024
CDER Launches New Quantitative Medicine Center of Excellence

FDA’s Center for Drug Evaluation and Research (CDER) has announced the establishment of a new Quantitative Medicine Center of Excellence to promote the use of modeling and simulation in drug development and review.

The agency defines Quantitative Medicine (QM) as “the 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.”

This center-wide effort will build on existing quantitative approaches to facilitate drug development and assessment, including model-informed drug development (MIDD), complex innovative trial design (CID), and CDER’s Fit-for-Purpose initiative.

“For decades, CDER has been at the forefront of advancing QM approaches to inform premarket product review and post-market product assessment,” said Patrizia Cavazzoni, M.D., director of CDER. “Given the tremendous growth in QM, we see many opportunities to strengthen collaboration across CDER by centrally coordinating outreach, education, scientific and regulatory policy, to facilitate the consistent use of QM approaches during drug development and to inform regulatory decision making.”

On April 25, CDER will host a public workshop on Quantitative Medicine and will share more about the new Center of Excellence and solicit feedback. To register: Streamlining Drug Development and Improving Public Health through Quantitative Medicine: An Introduction to the CDER Quantitative Medicine Center of Excellence.