Notice2026-09268
Postapproval Pregnancy Safety Studies; Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
May 11, 2026
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 final guidance for industry titled "Postapproval Pregnancy Safety Studies." The purpose of this guidance will be to provide sponsors and investigators with recommendations on how to design investigations to assess the outcomes in pregnant women exposed to drug and biological products regulated by FDA (i.e., pregnancy safety studies) in the postapproval setting. This guidance finalizes the draft guidance of the same name issued on May 9, 2019.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 90 (Monday, May 11, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 90 (Monday, May 11, 2026)]
[Notices]
[Pages 25579-25580]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-09268]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2018-D-4693]
Postapproval Pregnancy Safety Studies; Guidance for Industry;
Availability
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 final guidance for industry titled ``Postapproval
Pregnancy Safety Studies.'' The purpose of this guidance will be to
provide sponsors and investigators with recommendations on how to
design investigations to assess the outcomes in pregnant women exposed
to drug and biological products regulated by FDA (i.e., pregnancy
safety studies) in the postapproval setting. This guidance finalizes
the draft guidance of the same name issued on May 9, 2019.
DATES: The announcement of the guidance is published in the Federal
Register on May 11, 2026.
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:
<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 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-2018-D-4693 for ``Postapproval Pregnancy Safety Studies.'' 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
[[Page 25580]]
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 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
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
FOR FURTHER INFORMATION CONTACT: Denise Johnson-Lyles, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6469, Silver Spring, MD 20993, 301-796-
6169; or Phillip Kurs, Center for Biologics Evaluation and Research,
Food and Drug Administration, 240-402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a final guidance for industry
titled ``Postapproval Pregnancy Safety Studies.'' The purpose of this
guidance is to provide sponsors and investigators with recommendations
on how to design investigations to assess the safety outcomes in
pregnant women exposed to drug and biological products regulated by
FDA, in the postapproval setting. Currently, collection of safety data
in drug and biological products used during pregnancy usually occurs
after approval. Pregnancy registries have been used to collect these
data. However, in the years since FDA first issued guidance on this
topic, scientific methodologies for assessing the safety of drug and
biological products used during pregnancy in the postmarketing setting
have evolved.
This guidance finalizes the draft guidance titled ``Postapproval
Pregnancy Safety Studies'' issued on May 9, 2019 (84 FR 20371). FDA
considered comments received on the draft guidance as the guidance was
finalized. Changes from the draft to the final guidance include the
following: (1) clarifying the section on pregnancy registries,
including the addition of a subsection on statistical methods; (2)
broadening the scope of the complementary study methods sections; (3)
expanding the discussion on data collection in situations when rare
exposure to a drug during pregnancy is anticipated; and (4) updating
terminology to include descriptive pregnancy safety studies. In
addition, editorial changes were made to improve clarity.
This 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 ``Postapproval Pregnancy Safety Studies.''
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. FDA
considered the applicability of Executive Order 14192, per OMB guidance
in M-25-20, and finds this action to be an E.O. 14192 deregulatory
action.
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 314.50(d), 314.80(c)(2)(iii), and 314.81(b)(2)(vii)
pertaining to submissions of new drug applications for submitting
postmarketing safety reports, postmarketing study updates in annual
reports, and formal meetings between sponsors or applicants and FDA
have been approved under OMB control number 0910-0001. The collections
of information in 21 CFR 312.23(a)(6) pertaining to submitting
pregnancy registry design considerations in a protocol for
investigational new drug applications have been approved under OMB
control number 0910-0014. The collections of information in 21 CFR
parts 210 and 211 pertaining to current good manufacturing practices
have been approved under OMB control number 0910-0139. The collections
of information in 21 CFR parts 310.305(c) and 314.80(c)(2)(iii) and (e)
for submitting postmarketing safety reports have been approved under
OMB control number 0910-0230. The collections of information in 21 CFR
parts 310, 314, 600, and 803 for submitting postmarketing safety
reports under MedWatch have been approved under OMB control number
0910-0291. The collections of information in 21 CFR 601 pertaining to
biologics license applications have been approved under OMB control
number 0910-0338. The collections of information in 21 CFR 201.56 and
201.57 pertaining to human prescription drug labeling have been
approved under OMB control number 0910-0572.
III. Electronic Access
Persons with access to the internet may obtain the guidance at
<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>,
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-09268 Filed 5-8-26; 8:45 am]
BILLING CODE 4164-01-P
</pre></body>
</html>Indexed from Federal Register on May 11, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.