Notice2024-22580
Center for Drug Evaluation and Research Quantitative Medicine Center of Excellence; Program Announcement
Primary source
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Published
October 2, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 191 (Wednesday, October 2, 2024)</title>
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[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80257-80258]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2024-22580]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-N-4310]
Center for Drug Evaluation and Research Quantitative Medicine
Center of Excellence; Program Announcement
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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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 <a href="https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-quantitative-medicine-center-excellence-qm-coe">https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/cder-quantitative-medicine-center-excellence-qm-coe</a>.
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,
<a href="/cdn-cgi/l/email-protection#a3e7c2d3cbcdc68de4d6cacdcde3c5c7c28dcbcbd08dc4ccd5"><span class="__cf_email__" data-cfemail="2d694c5d454348036a584443436d4b494c0345455e034a425b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
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: (1) drug
development, (2) regulatory decision-making, and (3) patient care. The
technical scope includes pharmaco-statistical modeling, mechanistic
modeling, biomarker-endpoint development, artificial intelligence and
machine learning, and clinical trial simulations and in silico
predictions. Within CDER, QM approaches have been used to inform
premarket product review, post-market product assessment, policy
development, and policy implementation.
While CDER has been at the forefront of advancing QM over the
decades, the efforts in outreach and education, scientific and
regulatory initiatives, and operations have largely been decentralized.
Recognizing the opportunity for synergy, CDER has begun a coordinated
QM effort that maximally leverages its subject matter
[[Page 80258]]
experts, functional areas, and collective regulatory experience across
different offices.
II. Objectives of QM CoE
The QM CoE will facilitate and coordinate the continuous evolution
and consistent application of QM for drug development and regulatory
decision-making to advance therapeutic medical product development,
inform regulatory decision-making, and promote public health, by:
<bullet> spearheading QM-related policy development and best
practices to facilitate the consistent use of QM approaches during the
drug development and regulatory assessment;
<bullet> providing strategic direction for CDER's QM activities;
and
<bullet> coordinating CDER's efforts around QM education, training,
and community engagement.
III. Anticipated Outcomes of QM CoE
The QM CoE will harmonize existing activities and identify and
initiate new activities in the areas of multidisciplinary education and
exchange, science policy development and implementation, knowledge
management, and community engagement. The centralization of QM efforts
across CDER within the CoE will allow for operational optimization and
consistent application of QM approaches to advance therapeutic medical
product development, inform regulatory decision-making, and promote
public health.
Dated: September 26, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-22580 Filed 10-1-24; 8:45 am]
BILLING CODE 4164-01-P
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