Notice2025-13680
E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials; International Council for Harmonisation; Draft Guidance for Industry; Availability
Primary source
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Published
July 21, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "E21 Inclusion of Pregnant and Breastfeeding Women in Clinical Trials." The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance is intended to provide general principles on the conduct of clinical trials that include pregnant and breastfeeding women to inform evidence-based decisions on safe and effective use of medicinal products by these populations. The draft guidance includes approaches to generating data that support informed decision-making on the safety, dosing, and efficacy of medicinal products during pregnancy and breastfeeding. Additionally, the draft guidance includes recommendations for recruiting and retaining pregnant and breastfeeding women in clinical trials, while reducing burden and harm on these participants.
Full Text
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<title>Federal Register, Volume 90 Issue 137 (Monday, July 21, 2025)</title>
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[Federal Register Volume 90, Number 137 (Monday, July 21, 2025)]
[Notices]
[Pages 34279-34281]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-13680]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-D-1797]
E21 Inclusion of Pregnant and Breastfeeding Women in Clinical
Trials; International Council for Harmonisation; Draft Guidance for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``E21
Inclusion of Pregnant and Breastfeeding Women in Clinical Trials.'' The
draft guidance was prepared under the auspices of the International
Council for Harmonisation of Technical Requirements for Pharmaceuticals
for Human Use (ICH). The draft guidance is intended to provide general
principles on the conduct of clinical trials that include pregnant and
breastfeeding women to inform evidence-based decisions on safe and
effective use of medicinal products by these populations. The draft
guidance includes approaches to generating data that support informed
decision-making on the safety, dosing, and efficacy of medicinal
products during pregnancy and breastfeeding. Additionally, the draft
guidance includes recommendations for recruiting and retaining pregnant
and breastfeeding women in clinical trials, while reducing burden and
harm on these participants.
DATES: Submit either electronic or written comments on the draft
guidance by September 19, 2025 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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
[[Page 34280]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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-2025-D-1797 for ``E21 Inclusion of Pregnant and Breastfeeding Women
in Clinical Trials.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 the 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, or the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. The guidance may also be obtained by mail by calling
Center for Biologics Evaluation and Research at 1-800-835-4709 or 240-
402-8010. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Regarding the guidance: Leyla Sahin, Center for Drug Evaluation and
Research, Food and Drug Administration, <a href="/cdn-cgi/l/email-protection#cf83aab6a3aee19caea7a6a18fa9abaee1a7a7bce1a8a0b9"><span class="__cf_email__" data-cfemail="2e624b57424f007d4f4647406e484a4f0046465d00494158">[email protected]</span></a>; or
Phillip Kurs, Center for Biologics Evaluation and Research, Food and
Drug Administration, 240-402-7911; or Office of Women's Health, 10903
New Hampshire Ave., Bldg. 32, Rm. 2333, Silver Spring, MD 20993-0002,
301-796-9440.
Regarding the ICH: Brooke Dal Santo, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6304, Silver Spring, MD 20993-0002, 301-348-1967,
<a href="/cdn-cgi/l/email-protection#3d7f4f5252565813795c516e5c5349527d5b595c1355554e135a524b"><span class="__cf_email__" data-cfemail="b5f7c7dadaded09bf1d4d9e6d4dbc1daf5d3d1d49bddddc69bd2dac3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``E21 Inclusion of Pregnant and Breastfeeding Women in
Clinical Trials.'' The draft guidance was prepared under the auspices
of ICH. ICH seeks to achieve greater regulatory harmonization worldwide
to ensure that safe, effective, high-quality medicines are developed,
registered, and maintained in the most resource-efficient manner.
By harmonizing the regulatory requirements in regions around the
world, ICH guidelines enhance global drug development, improve
manufacturing standards, and increase the availability of medications.
For example, ICH guidelines have substantially reduced duplicative
clinical studies, prevented unnecessary animal studies, standardized
the reporting of important safety information, and standardized
marketing application submissions.
The six Founding Members of the ICH are the FDA; the Pharmaceutical
Research and Manufacturers of America; the European Commission; the
European Federation of Pharmaceutical Industries Associations; the
Japanese Ministry of Health, Labour, and Welfare; and the Japanese
Pharmaceutical Manufacturers Association. The Standing Members of the
ICH Association include Health Canada and Swissmedic. ICH membership
continues to expand to include other regulatory authorities and
industry associations from around the world (refer to <a href="https://www.ich.org/">https://www.ich.org/</a>).
ICH works by engaging global regulatory and industry experts in a
detailed, science-based, and consensus-driven process that results in
the development of ICH guidelines. The regulators around the world are
committed to consistently adopting these consensus-based guidelines,
realizing the benefits for patients and for industry.
As a Founding Regulatory Member of ICH, FDA plays a major role in
the development of each of the ICH guidelines, which FDA then adopts
and issues as guidance for industry. FDA's guidance documents do not
establish legally enforceable responsibilities. Instead, they describe
the Agency's current thinking on a topic and should be viewed only as
recommendations, unless specific regulatory or statutory requirements
are cited.
The recommendations found in this draft guidance are the product of
the Efficacy Working Group of the ICH. Comments about this draft will
be
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considered by FDA and the Efficacy Expert Working Group.
The draft guidance outlines strategies and considerations for
developing and implementing clinical studies that include pregnant or
breastfeeding women. This draft guidance includes approaches to plan,
collect data, evaluate outcomes, and monitor safety of pregnant and
breastfeeding women participating in clinical trials safely and
ethically. Additionally, the draft guidance includes recommendations
for recruiting and retaining pregnant and breastfeeding women in
clinical trials. The draft guidance also emphasizes reduction of burden
on pregnant and breastfeeding women participating in these trials.
This draft guidance has been left in the original ICH format. The
final guidance will be reformatted and edited to conform with FDA's
good guidance practices regulation (21 CFR 10.115) and style before
publication. The draft guidance, when finalized, will represent the
current thinking of FDA on ``E21 Inclusion of Pregnant and
Breastfeeding Women in Clinical Trials.'' 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.
As we develop final guidance on this topic, FDA will consider
comments on costs or cost savings the guidance may generate, relevant
for Executive Order 14192.
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 11 relating to electronic records and signatures have
been approved under OMB control number 0910-0303. The collections of
information in 21 CFR parts 50 and 56 relating to the protection of
human subjects, informed consent, and institutional review boards have
been approved under OMB control number 0910-0130. The collections of
information in 21 CFR part 58 relating to good laboratory practice for
nonclinical laboratory studies have been approved under OMB control
number 0910-0119. The collections of information in 21 CFR 201.56 and
201.57 relating to the content and format requirements of labeling for
prescription drug products have been approved under OMB control number
0910-0572. The collections of information in 21 CFR 310.305 and 314.80
relating to submission of adverse drug experience reports have been
approved under OMB control number 0910-0230. The collections of
information in 21 CFR part 312 relating to the investigational new drug
application pathway, which includes clinical trials, clinical trial
design, benefit-risk planning, and submission of IND safety reports and
reports of serious and unexpected adverse events have been approved
under OMB control number 0910-0014. The collections of information in
21 CFR part 314 relating to the content and format of investigational
new drugs applications, regulatory requirements relating to
postmarketing study commitments, and risk evaluation and mitigation
strategies relating to benefit-risk assessments, have been approved
under OMB control number 0910-0001.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.regulations.gov">https://www.regulations.gov</a>, <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances</a>, or <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>.
Dated: July 15, 2025
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-13680 Filed 7-18-25; 8:45 am]
BILLING CODE 4164-01-P
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