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# CDER Launches Quantitative Medicine Center
- URL: https://www.fdaweb.com/cder-launches-quantitative-medicine-center/
- Published: 2024-05-06T12:00:00.000Z
- Updated: 2026-09-14T14:30:04.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156926

CDER is announcing a new [Quantitative Medicine (QM) Center of Excellence (CoE)](https://lnks.gd/l/eyJhbGciOiJIUzI1NiJ9.eyJidWxsZXRpbl9saW5rX2lkIjoxMDEsInVyaSI6ImJwMjpjbGljayIsInVybCI6Imh0dHBzOi8vd3d3LmZkYS5nb3YvYWJvdXQtZmRhL2NlbnRlci1kcnVnLWV2YWx1YXRpb24tYW5kLXJlc2VhcmNoLWNkZXIvY2Rlci1xdWFudGl0YXRpdmUtbWVkaWNpbmUtY2VudGVyLWV4Y2VsbGVuY2UtcW0tY29lP3V0bV9tZWRpdW09ZW1haWwmdXRtX3NvdXJjZT1nb3ZkZWxpdmVyeSM6fjp0ZXh0PVRoZSUyMENlbnRlciUyMGZvciUyMERydWclMjBFdmFsdWF0aW9uLHJlZ3VsYXRvcnklMjBkZWNpc2lvbiUyRG1ha2luZyUyMGFjcm9zcyUyMENERVIuIiwiYnVsbGV0aW5faWQiOiIyMDI0MDUwNi45NDM4MDYwMSJ9.Y%5FOA7sPzVHZI79IVQwQfvEg7BPez8oe2cdIQVjQklBc/s/1255931999/br/241964853804-l?ref=fdaweb.com). “QM involves 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,” an [agency notice](https://content.govdelivery.com/accounts/USFDA/bulletins/39ad48d?ref=fdaweb.com) says. “The goal of this CDER QM CoE is to facilitate and coordinate the continuous evolution and consistent application of QM across the Center.” Activities it will conduct include:

- Spearheading QM-related policy development and best practices to help with consistently applying use of QM approaches during drug development and regulatory assessments
- Facilitating outreach to scientific societies, patient advocacy groups, and other stakeholders
- Coordinating CDER’s efforts around QM education and training

“Innovative technologies, tools, and approaches are increasingly utilized to improve drug development efficiency throughout the lifecycle, address complex issues and enable optimized treatments reaching patients,” CDER says. “By fostering integration of QM approaches across CDER, the CoE can help advance therapeutic medical product development and inform regulatory decision-making.” Overall, the Center of Excellence is expected to help streamline and accelerate drug development and speed the approval and access to effective medicines.