Considerations for the Use of Artificial Intelligence To Support Regulatory Decision-Making for Drug and Biological Products; Draft Guidance for Industry; Availability; Comment Request, 1157-1159 [2024-31542]
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
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criticized FDA regulation of IGAs in
animals for neglecting animal welfare.
The remaining comments came from
industry (companies that produce IGAs
and trade associations), individual
developers of IGAs in animals,
academics, non-governmental
organizations (consumer,
environmental), and individual
consumers.
FDA has made changes in the final
GFI #187B that include additional
explanation or clarification about: (1)
how FDA’s animal safety review
includes animal health and well-being;
(2) how compositional analysis relates
to the food safety evaluation; (3) what
FDA means by a ‘‘significant change’’
with respect to durability; (4) what can
be included in a single IGA-related
application; (5) what methods,
including methods other than whole
genome sequencing, may be most
appropriate for molecular
characterization of the lineage of
animals with the IGA; (6) further
clarification regarding data
expectations, including what data
constitutes a ‘‘full characterization’’ of
the site of alteration and potential
unintended alterations; and (7) more
detailed information on review
timelines. In addition, editorial changes
were made to improve clarity. The
guidance announced in this notice
finalizes the draft guidance dated May
2024.
This level 1 guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Heritable
Intentional Genomic Alterations in
Animals: The Approval Process.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 25 have been
approved under OMB control number
0910–0322; the collections of
information in 21 CFR part 58 have been
approved under OMB control number
0910–0119; the collections of
information in 21 CFR part 207 have
been approved under OMB control
VerDate Sep<11>2014
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number 0910–0045; the collections of
information in 21 CFR part 211 have
been approved under OMB control
number 0910–0139; the collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117; the collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0284; and the collections
of information in 21 CFR 558.6(a)(4)
have been approved under OMB control
number 0910–0363.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–31532 Filed 1–6–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–4689]
Considerations for the Use of Artificial
Intelligence To Support Regulatory
Decision-Making for Drug and
Biological Products; Draft Guidance
for Industry; Availability; Comment
Request
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Considerations for the Use of Artificial
Intelligence To Support Regulatory
Decision-Making for Drug and
Biological Products.’’ In accordance
with its mission of protecting,
promoting, and advancing public
health, FDA’s Center for Drug
Evaluation and Research (CDER), in
collaboration with the Center for
Biologics Evaluation and Research
(CBER), the Center for Devices and
Radiological Health (CDRH), the Center
for Veterinary Medicine (CVM), the
Oncology Center of Excellence (OCE),
the Office of Combination Products
(OCP), and the Office of Inspections and
Investigations (OII), is issuing this draft
SUMMARY:
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guidance to provide recommendations
to industry on the use of artificial
intelligence (AI) to produce information
or data intended to support regulatory
decision-making regarding the safety,
effectiveness, or quality for drug and
biological products.
DATES: Submit either electronic or
written comments on the draft guidance
by April 7, 2025 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
Submit electronic or written comments
on the proposed collection of
information in the draft guidance by
April 7, 2025.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No.
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1158
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
FDA–2024–D–4689 for ‘‘Considerations
for the Use of Artificial Intelligence To
Support Regulatory Decision-Making for
Drug and Biological Products; Guidance
for Industry.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852, 240–402–7500.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of this draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
VerDate Sep<11>2014
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Jkt 265001
0002. Send one self-addressed adhesive
label to assist that office in processing
your request or include a Fax number to
which the draft guidance may be sent.
See the SUPPLEMENTARY INFORMATION
section for information on electronic
access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Tala
Fakhouri, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 6330, Silver Spring,
MD 20993–0002, 301–837–7407,
Tala.Fakhouri@fda.hhs.gov; James
Myers, Center for Biologics Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 71, Rm. 7301, Silver Spring,
MD 20993–0002, 240–402–7911,
James.Myers@fda.hhs.gov; or Sonja
Fulmer, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5530, Silver Spring,
MD 20993–0002, 240–402–5979,
Sonja.Fulmer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance entitled
‘‘Considerations for the Use of Artificial
Intelligence To Support Regulatory
Decision-Making for Drug and
Biological Products.’’ This draft
guidance, when finalized, will provide
recommendations to industry on the use
of AI to produce information or data
intended to support regulatory decisionmaking regarding safety, effectiveness,
or quality for drugs. Specifically, this
guidance proposes a risk-based
credibility assessment framework that
may be used for establishing and
evaluating the credibility of an AI model
for a particular context of use (COU).
For the purposes of this guidance,
credibility refers to trust, established
through the collection of credibility
evidence, in the performance of an AI
model for a particular COU. Credibility
evidence is any evidence that could
support the credibility of an AI model
output for a specific COU. The COU
defines the specific role and scope of
the AI model used to address a question
of interest. This guidance does not
endorse the use of any specific AI
approach or technique.
This draft guidance discusses the use
of AI models in the nonclinical, clinical,
postmarketing, and manufacturing
phases of the drug product life cycle,
where the specific use of the AI model
is to produce information or data to
support regulatory decision-making
regarding safety, effectiveness, or
quality for drugs. This draft guidance
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does not address the use of AI models:
(1) in drug discovery or (2) when used
for operational efficiencies (e.g., internal
workflows, resource allocation, drafting/
writing a regulatory submission) that do
not impact patient safety, drug quality,
or the reliability of results from a
nonclinical or clinical study. We
encourage sponsors to engage with FDA
early if they are uncertain about
whether or not their use of AI is within
the scope of this guidance.
The Agency recognizes that the use of
AI in drug development is broad and
rapidly evolving. This draft guidance,
when finalized, is expected to help
ensure that AI models used to support
regulatory decision-making are
sufficiently credible for the COU. The
risk-based credibility assessment
framework proposed in this draft
guidance is intended to help sponsors
and other interested parties plan, gather,
organize, and document information to
establish the credibility of AI model
outputs. As described in this guidance,
the proposed recommendations,
considerations, and assessment
activities (e.g., the level of oversight, the
stringency of the credibility assessments
and the performance acceptance criteria,
the risk mitigation strategy, and the
amount of documentation and detail
associated with AI use) that can be used
to establish model credibility will
generally be tailored to the specific COU
and will depend on model risk.
This draft guidance also describes
different options by which industry may
engage with the Agency on issues
related to AI model development. The
draft guidance emphasizes the
importance of early engagement with
the Agency to help: (1) set expectations
regarding the appropriate credibility
assessment activities for the proposed
model based on model risk and COU
and (2) identify potential challenges and
how such challenges may be addressed.
The Agency recognizes, however, that
certain uses of AI occur outside of the
product development and marketing
application processes with established
meeting options. Specifically, in the
context of postmarketing
pharmacovigilance, certain
documentation (e.g., processes and
procedures) is not generally submitted
to the Agency but is maintained
according to the sponsor’s standard
operating procedures and made
available to the Agency upon request
(e.g., during an inspection). In such
cases, sponsors may choose to complete
all the steps outlined in the draft
guidance without seeking early
engagement with the Agency. Sponsors
remain responsible for compliance with
statutory and regulatory requirements,
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
including postmarketing safety
surveillance and reporting
requirements, regardless of the
technology utilized.
The Agency also recognizes that
sponsors may have questions about
credibility assessment plans in
connection with the postmarketing
phase. Therefore, the Agency seeks
feedback about whether development of
additional guidance specific to the use
of AI models in postmarketing
pharmacovigilance would be helpful
and, if so, the topics that would be most
useful for the Agency to address. For
general discussion about the use of AI
models or other emerging technologies
in pharmacovigilance, FDA has
established the Emerging Drug Safety
Technology Meeting (EDSTM) Program.
The risk-based credibility assessment
framework proposed within the draft
guidance is informed by: (1) over 800
comments received on the 2023
discussion papers published by CDER
entitled ‘‘Using Artificial Intelligence &
Machine Learning in the Development
of Drug & Biological Products’’ (https://
www.fda.gov/media/167973/download)
and ‘‘Artificial Intelligence in Drug
Manufacturing’’ (https://www.fda.gov/
media/165743/download); (2) FDA’s
experience with reviewing over 300
submissions with AI and machine
learning components across all phases
of the drug development process; and
(3) current regulatory science research.
However, FDA understands that this is
a rapidly evolving field, involving
multidisciplinary expertise. FDA
requests public comment from industry
and all other interested parties on the
guidance, with emphasis on the
following items:
• How well the proposed risk-based
credibility assessment framework aligns
with industry’s experience; and
• Whether the options available for
sponsors and other interested parties to
engage with FDA on AI are sufficient.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on the use of AI to support regulatory
decision-making for drug and biological
products. It does not establish any rights
for any person and is not binding on
FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. The previously approved
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (PRA) (44 U.S.C.
3501–3521). The collections of
information in 21 CFR part 312 have
been approved under OMB control
number 0910–0014; the collections of
information in 21 CFR part 314 have
been approved under OMB control
number 0910–0001; the collections of
information in 21 CFR part 601 have
been approved under OMB control
number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
draft guidance at https://www.fda.gov/
drugs/guidance-compliance-regulatoryinformation/guidances-drugs, https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
medical-devices/device-advicecomprehensive-regulatory-assistance/
guidance-documents-medical-devicesand-radiation-emitting-products,
https://www.fda.gov/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–31542 Filed 1–6–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–D–0756]
Validation and Verification of
Analytical Testing Methods Used for
Tobacco Products; Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a final
guidance for industry entitled
‘‘Validation and Verification of
Analytical Testing Methods Used for
Tobacco Products.’’ The guidance
provides information and
recommendations related to the
validation and verification of analytical
test methods, including analytical
testing of tobacco product constituents,
ingredients, and additives, as well as
SUMMARY:
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1159
stability testing of tobacco products.
This guidance is intended to help
industry produce more consistent and
reliable analytical data used to support
regulatory submissions for finished
tobacco products. This guidance
finalizes the draft guidance of the same
title issued in December 2021.
DATES: The announcement of the
guidance is published in the Federal
Register on January 7, 2025.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked, and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2021–D–0756 for ‘‘Validation and
Verification of Analytical Testing
Methods Used for Tobacco Products.’’
E:\FR\FM\07JAN1.SGM
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]]>Agencies
[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1157-1159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31542]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-4689]
Considerations for the Use of Artificial Intelligence To Support
Regulatory Decision-Making for Drug and Biological Products; Draft
Guidance for Industry; Availability; Comment Request
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Considerations for the Use of Artificial Intelligence To Support
Regulatory Decision-Making for Drug and Biological Products.'' In
accordance with its mission of protecting, promoting, and advancing
public health, FDA's Center for Drug Evaluation and Research (CDER), in
collaboration with the Center for Biologics Evaluation and Research
(CBER), the Center for Devices and Radiological Health (CDRH), the
Center for Veterinary Medicine (CVM), the Oncology Center of Excellence
(OCE), the Office of Combination Products (OCP), and the Office of
Inspections and Investigations (OII), is issuing this draft guidance to
provide recommendations to industry on the use of artificial
intelligence (AI) to produce information or data intended to support
regulatory decision-making regarding the safety, effectiveness, or
quality for drug and biological products.
DATES: Submit either electronic or written comments on the draft
guidance by April 7, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance. Submit electronic or written comments on the
proposed collection of information in the draft guidance by April 7,
2025.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
[[Page 1158]]
FDA-2024-D-4689 for ``Considerations for the Use of Artificial
Intelligence To Support Regulatory Decision-Making for Drug and
Biological Products; Guidance for Industry.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of this draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
request or include a Fax number to which the draft guidance may be
sent. See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance.
FOR FURTHER INFORMATION CONTACT: Tala Fakhouri, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6330, Silver Spring, MD 20993-0002, 301-
837-7407, [email protected]; James Myers, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911, [email protected]; or Sonja Fulmer, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 240-
402-5979, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance entitled
``Considerations for the Use of Artificial Intelligence To Support
Regulatory Decision-Making for Drug and Biological Products.'' This
draft guidance, when finalized, will provide recommendations to
industry on the use of AI to produce information or data intended to
support regulatory decision-making regarding safety, effectiveness, or
quality for drugs. Specifically, this guidance proposes a risk-based
credibility assessment framework that may be used for establishing and
evaluating the credibility of an AI model for a particular context of
use (COU). For the purposes of this guidance, credibility refers to
trust, established through the collection of credibility evidence, in
the performance of an AI model for a particular COU. Credibility
evidence is any evidence that could support the credibility of an AI
model output for a specific COU. The COU defines the specific role and
scope of the AI model used to address a question of interest. This
guidance does not endorse the use of any specific AI approach or
technique.
This draft guidance discusses the use of AI models in the
nonclinical, clinical, postmarketing, and manufacturing phases of the
drug product life cycle, where the specific use of the AI model is to
produce information or data to support regulatory decision-making
regarding safety, effectiveness, or quality for drugs. This draft
guidance does not address the use of AI models: (1) in drug discovery
or (2) when used for operational efficiencies (e.g., internal
workflows, resource allocation, drafting/writing a regulatory
submission) that do not impact patient safety, drug quality, or the
reliability of results from a nonclinical or clinical study. We
encourage sponsors to engage with FDA early if they are uncertain about
whether or not their use of AI is within the scope of this guidance.
The Agency recognizes that the use of AI in drug development is
broad and rapidly evolving. This draft guidance, when finalized, is
expected to help ensure that AI models used to support regulatory
decision-making are sufficiently credible for the COU. The risk-based
credibility assessment framework proposed in this draft guidance is
intended to help sponsors and other interested parties plan, gather,
organize, and document information to establish the credibility of AI
model outputs. As described in this guidance, the proposed
recommendations, considerations, and assessment activities (e.g., the
level of oversight, the stringency of the credibility assessments and
the performance acceptance criteria, the risk mitigation strategy, and
the amount of documentation and detail associated with AI use) that can
be used to establish model credibility will generally be tailored to
the specific COU and will depend on model risk.
This draft guidance also describes different options by which
industry may engage with the Agency on issues related to AI model
development. The draft guidance emphasizes the importance of early
engagement with the Agency to help: (1) set expectations regarding the
appropriate credibility assessment activities for the proposed model
based on model risk and COU and (2) identify potential challenges and
how such challenges may be addressed. The Agency recognizes, however,
that certain uses of AI occur outside of the product development and
marketing application processes with established meeting options.
Specifically, in the context of postmarketing pharmacovigilance,
certain documentation (e.g., processes and procedures) is not generally
submitted to the Agency but is maintained according to the sponsor's
standard operating procedures and made available to the Agency upon
request (e.g., during an inspection). In such cases, sponsors may
choose to complete all the steps outlined in the draft guidance without
seeking early engagement with the Agency. Sponsors remain responsible
for compliance with statutory and regulatory requirements,
[[Page 1159]]
including postmarketing safety surveillance and reporting requirements,
regardless of the technology utilized.
The Agency also recognizes that sponsors may have questions about
credibility assessment plans in connection with the postmarketing
phase. Therefore, the Agency seeks feedback about whether development
of additional guidance specific to the use of AI models in
postmarketing pharmacovigilance would be helpful and, if so, the topics
that would be most useful for the Agency to address. For general
discussion about the use of AI models or other emerging technologies in
pharmacovigilance, FDA has established the Emerging Drug Safety
Technology Meeting (EDSTM) Program.
The risk-based credibility assessment framework proposed within the
draft guidance is informed by: (1) over 800 comments received on the
2023 discussion papers published by CDER entitled ``Using Artificial
Intelligence & Machine Learning in the Development of Drug & Biological
Products'' (https://www.fda.gov/media/167973/download) and ``Artificial
Intelligence in Drug Manufacturing'' (https://www.fda.gov/media/165743/download); (2) FDA's experience with reviewing over 300 submissions
with AI and machine learning components across all phases of the drug
development process; and (3) current regulatory science research.
However, FDA understands that this is a rapidly evolving field,
involving multidisciplinary expertise. FDA requests public comment from
industry and all other interested parties on the guidance, with
emphasis on the following items:
How well the proposed risk-based credibility assessment
framework aligns with industry's experience; and
Whether the options available for sponsors and other
interested parties to engage with FDA on AI are sufficient.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on the use of AI
to support regulatory decision-making for drug and biological products.
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 312 have been approved under OMB control number 0910-
0014; the collections of information in 21 CFR part 314 have been
approved under OMB control number 0910-0001; the collections of
information in 21 CFR part 601 have been approved under OMB control
number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain an electronic
version of the draft guidance at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31542 Filed 1-6-25; 8:45 am]
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