[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]
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