The Center for Drug Evaluation and Research (CDER) Quantitative Medicine (QM) Center of Excellence (CoE) is established to facilitate and coordinate the continuous evolution and consistent application of QM for drug development and regulatory decision-making across CDER.

For decades, CDER offices have been at the forefront of advancing QM approaches to inform premarket product review and post-market product assessment. Given the tremendous growth in QM, we see many opportunities to maximize synergies across CDER by centrally coordinating efforts through strategic planning and execution. The QM CoE seeks to strengthen collaborations in outreach, education, scientific and regulatory initiatives, as well as policy development and implementation. The QM CoE will be a CDER-wide enterprise that will function as a cooperative, coordinating body that spurs innovation and fosters integration of QM approaches to advance therapeutic medical product development, inform regulatory decision-making, and promote public health.

To learn more about the establishment of the QM CoE, view the CDER statement. 

Activities of the CoE

The CoE will introduce new activities and coordinate existing activities in three main areas: Strategic Planning & Coordination, Multidisciplinary Education and Exchange, and Applied Science Policy.