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. To learn more about the QM CoE’s recent accomplishments, read the 2025 Progress and Priorities Report.

Activities of the CoE

The CoE will introduce new activities and coordinate existing activities in three main areas: Applied Regulatory Science, Enterprise Planning and Coordination, and Education and Ecosystem Development.

Applied Regulatory Science activities include:

Knowledge Management: Warehouse and promote best practices and standards related to QM; document and disseminate outcomes of QM applications
Policy Development: Facilitate scientific exchange and lead the development and implementation of evidence-based scientific guidances, policies and best practices

Enterprise Planning and Coordination activities include:

Strategic Planning: Identify and prioritize gaps in knowledge and determine areas of further research and development in CDER
Coordination: Coordinate and elevate existing QM-related scientific and regulatory initiatives and outreach and educational activities within CDER

Education and Ecosystem Development activities include:

Educational Enrichment: Provide applied regulatory science educational opportunities and resources internally and externally to promote the implementation and uptake of QM techniques
Community Engagement: Convene and engage key external stakeholders through outreach activities and collaborations with experts