The FDA’s Center for Drug Evaluation and Research (CDER) is excited to introduce the new CDER Quantitative Medicine (QM) Center of Excellence (CoE).

QM involves leveraging exposure-based, biological, and quantitative modeling and simulation approaches from various sources, including nonclinical, clinical, and real-world data. These methods play a crucial role in shaping drug development, regulatory decisions, and patient care, enriching our understanding of a drug’s benefits and risks.

The primary objective of this CoE is to streamline and enhance the integration of QM practices throughout CDER.

Dr. Patrizia Cavazzoni, Director of CDER, expressed, “CDER has long championed QM approaches for premarket product reviews and post-market assessments. With the expanding scope of QM, we recognize ample opportunities to foster collaboration within CDER. By centralizing outreach, education, scientific and regulatory policies, we aim to promote the uniform adoption of QM methodologies in drug development and regulatory deliberations.”

You can read the full text here.

References

  1. Research, C. F. D. E. A. (2024, March 25). CDER establishes new Quantitative Medicine Center of Excellence. U.S. Food And Drug Administration. https://www.fda.gov/drugs/drug-safety-and-availability/cder-establishes-new-quantitative-medicine-center-excellence

Disclaimers

  • The material in these reviews is from various public open-access sources, meant for educational and informational purposes only
  • Any personal opinions expressed are those of only the author(s) and are not intended to represent the position of any organization(s)
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