CDER Establishes New Quantitative Medicine Center of Excellence

The FDA on Monday announced creation of the new Quantitative Medicine (QM) Center of Excellence to facilitate and coordinate the continuous evolution and consistent application of QM across CDER.

QM relates to the development and application of exposure-based, biological, and quantitative modeling and simulation approaches derived from nonclinical, clinical, and real-world sources to inform drug development, regulatory decision-making, and patient care. These approaches contribute to the totality of understanding of a drug’s benefits and risks, helping to advance the drug through the regulatory process.

CDER’s Quantitative Medicine Center of Excellence will, among other things, lead QM-related policy development and best practices to facilitate the use of QM during drug development and regulatory assessment and facilitate outreach to scientific societies, patient advocacy groups, and other key stakeholders. On April 25 CDER will host a public workshop on the QM Center of Excellence.

Register for the workshop here.

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