FDA Creates New Center Of Excellence To Boost Use Of Modeling, Simulation

FDA’s Center for Drug Evaluation and Research (CDER) is creating a new “Quantitative Medicine Center of Excellence” (QM CoE) to bolster its use of modeling and simulation in the drug development and regulatory process. The new center will leverage data from nonclinical, clinical and real-world sources, translated into mathematical models, to provide a more comprehensive understanding of a drug’s benefits and risks to improve FDA’s regulatory decision-making. It was announced in an FDA statement Monday (March 25). CDER will host...