[Federal Register Volume 89, Number 191 (Wednesday, October 2, 2024)]
[Notices]
[Pages 80257-80258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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 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, 
<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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