FDA’s CDER establishes new center of excellence focused on quantitative medicine
27 Mar 2024
The FDA is strengthening its focus on using mathematical simulation and modeling to guide drug development with a new center of excellence housed in the Center for Drug Evaluation and Research, the agency
announced
Monday.
The Quantitative Medicine Center of Excellence will be tasked with facilitating the applications of quantitative medicine (QM) as it evolves. QM has been used across several different areas, including biomarker-endpoint development, clinical trial simulations, as well as machine learning and artificial intelligence. It’s happening as the FDA focuses more on using mathematical simulations in drug development. The agency in 2022 wrapped up a
successful
pilot program that gave sponsors additional access to the FDA to aid in model-informed drug development.
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