[Federal Register Volume 89, Number 113 (Tuesday, June 11, 2024)]
[Notices]
[Pages 49179-49180]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-12770]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-2332]


Emerging Drug Safety Technology Meetings; Program Announcement

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Center for Drug Evaluation and Research (CDER) within the 
Food and Drug Administration (FDA or we) is announcing a meeting 
program, the Emerging Drug Safety Technology Meeting (EDSTM) program. 
These meetings will be administered by staff in the newly established 
CDER Emerging Drug Safety Technology Program (EDSTP). EDSTMs provide 
applicants with an approved application and/or other relevant parties 
supporting industry's pharmacovigilance (PV) activities (e.g., 
academia, contract research organizations (CROs), pharmacovigilance 
vendors, software developers) who meet the eligibility and selection 
criteria for participation with an opportunity to meet with CDER staff 
to discuss their research, development, and use of Artificial 
Intelligence (AI) and other emerging technologies in PV. The goals of 
the meeting program in its initial phase are to facilitate mutual 
learning and discussion of the pharmaceutical industry's application of 
these technologies to PV, including efforts to validate and verify 
relevant models. While the EDSTP is specifically focused on the use of 
AI in PV for postmarket activities, it is part of CDER's multifaceted 
approach to enhance mutual learning of where and how specific 
innovations, such as AI, can best be used across the drug product life 
cycle.

DATES: Applicants and other relevant parties may submit meeting 
requests under the program beginning June 11, 2024.

ADDRESSES: For additional information about the EDSTM program, please 
refer to FDA's web page at https://www.fda.gov/drugs/science-and-research-drugs/cder-emerging-drug-safety-technology-program-edstp.

FOR FURTHER INFORMATION CONTACT: Ricardo Hernandez, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Silver Spring, MD 20993-0002, 240-402-9526, 
or email [email protected] with the subject line 
``EDSTM--General Inquiry''.

SUPPLEMENTARY INFORMATION:

I. Background

    The pharmaceutical industry is expanding its use of AI and other 
emerging technology across the drug product life cycle. FDA is 
interested in accelerating its understanding of the research, 
development, and use of AI and other emerging technology in the area of 
pharmacovigilance, including their performance characteristics. The 
EDSTM is a means by which applicants and other relevant parties who 
meet the eligibility and selection criteria for participation, can meet 
with CDER to share information about their use of AI and other emerging 
technology, and its potential application in PV, including efforts to 
validate and verify relevant models.
    The goal of the EDSTM is to facilitate mutual learning and 
discussion on the opportunities and challenges with using such 
technologies in PV. If selected for a meeting, application holders and/
or other relevant parties will meet with CDER staff to discuss their 
research, development, and/or use of AI and other emerging technologies 
in PV. FDA plans to leverage these learnings to help inform potential 
regulatory and policy approaches, within the use of emerging technology 
in PV. The EDSTM program is not an avenue to seek regulatory advice on 
compliance with pharmacovigilance regulations. Rather, we expect that 
the information gained during this program will help CDER consider 
providing regulatory advice on specific technologies to facilitate 
their adoption when appropriate. The discussions and background 
information submitted through the EDSTMs are nonbinding on both FDA and 
EDSTM requesters.
    EDSTMs may be requested by applicants with at least one approved 
application regulated by CDER, including new drug applications, 
abbreviated new drug applications, or biologics license applications, 
and/or by other relevant parties supporting industry's PV activities 
(e.g., academia, CROs/PV vendors, software developers) who develop, 
leverage, or intend to leverage AI or other emerging technology that 
can be used to satisfy the postmarketing reporting requirements in 21 
CFR 314.80, 314.98, and 600.80. Eligible parties, such as an applicant 
or an applicant's PV vendor, may request meetings separately or in 
partnership. Requests may be submitted on a rolling basis and will be 
reviewed quarterly each calendar year. Please refer to the EDSTM 
program web page for details on submission deadlines for quarterly 
review. CDER will select up to

[[Page 49180]]

nine participants whose submissions meet the eligibility and selection 
criteria in a 12-month period for the initial phase of the EDSTM.
    FDA has a longstanding commitment to ensure medicines marketed in 
the United States are safe through continued surveillance and research 
following approval. In the postmarket setting, regulated industry is 
obligated to review all adverse drug experience information received or 
otherwise obtained and submit timely reports to FDA. Both industry and 
regulatory authorities face challenges with timely and efficient 
collection, processing, and evaluation of single and aggregate patient 
safety data compounded by ever-increasing case volumes. Advances in 
emerging technology have the potential to address some of these 
challenges by creating more efficiencies within a PV system. For 
example, early adopters of AI are leveraging these emerging 
technologies to automate fundamental tasks (e.g., adverse event intake, 
data entry, and processing) with the intention to drive down associated 
administrative burden and costs. These technologies can also make 
safety surveillance more efficient and effective by capturing, 
aggregating, and analyzing larger and more diverse data sets.
    FDA recognizes industry's interest in dialogue around AI 
capabilities that advance PV. Knowledge and awareness of emerging 
technology tools, such as AI, and how they are used to advance PV will 
help inform CDER's regulatory approaches and policies. FDA expects that 
increased communication with industry and/or other relevant parties 
during EDSTMs will accelerate FDA's understanding of how AI enabled 
tools are being used for PV, their associated risks and benefits, and 
barriers to implementation.
    FDA has established an EDSTP website that includes EDSTM 
eligibility and selection criteria, instructions for submission of a 
meeting request, meeting request and package content descriptions, and 
submission timelines. The program's website address is https://www.fda.gov/drugs/science-and-research-drugs/cder-emerging-drug-safety-technology-program-edstp.

II. Paperwork Reduction Act of 1995

    Collections of information from fewer than 10 respondents within 
any 12-month period are not subject to the Paperwork Reduction Act of 
1995 (PRA) (5 CFR 1320.3(c)(4)). For the initial phase of this program, 
FDA will request information from no more than nine sponsors. Initial 
requests from sponsors interested in participation in the program are 
not ``information'' in accordance with 5 CFR 1320.3(h)(1). Therefore, 
clearance by the Office of Management and Budget under the PRA is not 
required.

    Dated: June 6, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-12770 Filed 6-10-24; 8:45 am]
BILLING CODE 4164-01-P