Health and Human Services Department, Food and Drug Administration
The Food and Drug Administration (FDA or Agency) is publishing this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE). Quantitative medicine (QM) is used to inform premarket product review, post-market product assessment, policy development, and policy implementation within several CDER offices. The QM CoE will act as a coordinating body that drives innovation and facilitates integration of QM methodologies and principles across CDER. To realize this purpose, the QM CoE will introduce new activities and coordinate existing activities in key areas, including multidisciplinary education and exchange, development and implementation of applied science policy, knowledge management, and community engagement.
Document Headings Document headings vary by document type but may contain the following: the agency or agencies that issued and signed a document the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to the agency docket number / agency internal file number the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions See the Document Drafting Handbook for more details. Department of Health and Human Services Food and Drug Administration [Docket No. FDA-2024-N-4310] AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing this notice to announce the establishment of the Center for Drug Evaluation and Research (CDER) Quantitative Medicine Center of Excellence (QM CoE). Quantitative medicine (QM) is used to inform premarket product review, post-market product assessment, policy development, and policy implementation within several CDER offices. The QM CoE will act as a coordinating body that drives innovation and facilitates integration of QM methodologies and principles across CDER. To realize this purpose, the QM CoE will introduce new activities and coordinate existing activities in key areas, including multidisciplinary education and exchange, development and implementation of applied science policy, knowledge management, and community engagement. DATES: The formation of the QM CoE was announced on March 25, 2024. For more details, please visit https://www.fda.gov/​about-fda/​center-drug-evaluation-and-research-cder/​cder-quantitative-medicine-center-excellence-qm-coe . FOR FURTHER INFORMATION CONTACT: Daphne Guinn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-837-7122, Daphne.Guinn@fda.hhs.gov . SUPPLEMENTARY INFORMATION: I. Background QM involves the development and a…
Citation: 89 FR 80257
