Health and Human Services Department, Food and Drug Administration
The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or Agency), through its Quantitative Medicine Center of Excellence (QM CoE), is announcing a request for information to inform the development of a Quantitative Medicine Innovation Network (QMIN). The vision for the QMIN is to create a cross-sector collaborative platform that accelerates the translation of quantitative medicine approaches to transform drug development, regulatory science, and clinical decision-making for patient benefit. The purpose of this request is to obtain feedback from industry, academia, healthcare providers, patient groups, and other interested parties on identifying critical community needs and establishing mechanisms for continuous engagement, supporting collaborative demonstration projects or research on innovative approaches aimed at addressing high priority areas through the application of QM approaches, and exploring mechanisms to leverage community expertise and capacity to promote QM innovation and adoption. Information submitted in response to this request will be considered in shaping the structure, priorities, and activities of the QMIN.
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-2026-N-7605] AGENCY: Food and Drug Administration, HHS. ACTION: Notice; request for information. SUMMARY: The Center for Drug Evaluation and Research (CDER) within the Food and Drug Administration (FDA or Agency), through its Quantitative Medicine Center of Excellence (QM CoE), is announcing a request for information to inform the development of a Quantitative Medicine Innovation Network (QMIN). The vision for the QMIN is to create a cross-sector collaborative platform that accelerates the translation of quantitative medicine approaches to transform drug development, regulatory science, and clinical decision-making for patient benefit. The purpose of this request is to obtain feedback from industry, academia, healthcare providers, patient groups, and other interested parties on identifying critical community needs and establishing mechanisms for continuous engagement, supporting collaborative demonstration projects or research on innovative approaches aimed at addressing high priority areas through the application of QM approaches, and exploring mechanisms to leverage community expertise and capacity to promote QM innovation and adoption. Information submitted in response to this request will be considered in shaping the structure, priorities, and activities of the QMIN. DATES: Either electronic or written comments on the notice must be submitted by November 3, 2026. ADDRESSES: You may submit…
Citation: 91 FR 50553
