Notice2025-21798
QTc Information in Human Prescription Drug and Biological Product Labeling; Guidance for Industry; Availability
Primary source
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Published
December 3, 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 guidance for industry entitled "QTc Information in Human Prescription Drug and Biological Product Labeling." This guidance is intended to assist applicants with incorporating heart rate-corrected QT (QTc) interval prolongation-related information into the labeling of non-antiarrhythmic human prescription drug and biological products. The guidance provides recommendations on how and where to appropriately include the clinically relevant information on QTc interval prolongation in the labeling, in accordance with regulatory requirements for the content and format of human prescription drug labeling. This guidance finalizes the draft guidance of the same title issued on August 8, 2023.
Full Text
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<title>Federal Register, Volume 90 Issue 230 (Wednesday, December 3, 2025)</title>
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[Federal Register Volume 90, Number 230 (Wednesday, December 3, 2025)]
[Notices]
[Pages 55741-55742]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-21798]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-2439]
QTc Information in Human Prescription Drug and Biological Product
Labeling; 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 guidance for industry entitled ``QTc Information
in Human Prescription Drug and Biological Product Labeling.'' This
guidance is intended to assist applicants with incorporating heart
rate-corrected QT (QTc) interval prolongation-related information into
the labeling of non-antiarrhythmic human prescription drug and
biological products. The guidance provides recommendations on how and
where to appropriately include the clinically relevant information on
QTc interval prolongation in the labeling, in accordance with
regulatory requirements for the content and format of human
prescription drug labeling. This guidance finalizes the draft guidance
of the same title issued on August 8, 2023.
DATES: The announcement of the guidance is published in the Federal
Register on December 3, 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:
<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-2023-D-2439 for ``QTc Information in Human Prescription Drug and
Biological Product Labeling.'' 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.
[[Page 55742]]
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: Laleh Amiri-Kordestani, Oncology
Center of Excellence and Center for Drug Evaluation and Research, Food
and Drug Administration, <a href="/cdn-cgi/l/email-protection#4e010d0b63093b272a2f202d2b3d0e282a2f6026263d60292138"><span class="__cf_email__" data-cfemail="1c535f59315b6975787d727f796f5c7a787d3274746f327b736a">[email protected]</span></a>; 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 guidance for industry
entitled ``QTc Information in Human Prescription Drug and Biological
Product Labeling.'' This guidance is intended to assist applicants with
incorporating heart rate-corrected QT (QTc) interval prolongation-
related information into the labeling of non-antiarrhythmic human
prescription drug and biological products. An undesirable property of
some non-antiarrhythmic drugs is their ability to delay cardiac
repolarization. A delay in cardiac repolarization creates an
electrophysiological environment that favors the development of torsade
de pointes (TdP), which can progress to ventricular fibrillation,
leading to sudden death. While the degree of QTc interval prolongation
is recognized as an imperfect biomarker for proarrhythmic risk, in
general, there is a qualitative relationship between QTc interval
prolongation and the risk of TdP, especially for drugs that cause
prolongation of the QTc interval due to inhibition of the delayed
rectifier potassium channel.
FDA and the International Council for Harmonisation recommend that
applicants for most non-antiarrhythmic drugs with systemic
bioavailability assess effect on cardiac repolarization early in
clinical development including a clinical electrocardiographic
evaluation. The QTc assessment in early clinical development may inform
the frequency and continuation of electrocardiogram monitoring in late
phase clinical trials. The guidance provides recommendations and
examples on how and where to appropriately include the clinically
relevant information on QTc interval prolongation in labeling, in
accordance with regulatory requirements for the content and format of
human prescription drug labeling.
This guidance finalizes the draft guidance entitled, ``QTc
Information in Human Prescription Drug and Biological Product
Labeling,'' issued on August 8, 2023 (88 FR 53501). FDA considered
comments received on the draft guidance as the guidance was finalized.
Changes from the draft guidance to the final guidance include adding a
section providing recommendations for including QTc interval
prolongation information in FDA-approved patient labeling and a section
for updating QTc interval prolongation information in currently-
approved labeling. In addition, minor revisions and 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 ``QTc Information in Human Prescription Drug
and Biological Product Labeling.'' 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 201.56 and 201.57 have been approved under OMB control number
0910-0572; the collections of information in 21 CFR 208 have been
approved under OMB control number 0910-0393; 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; and 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 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/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>.
Lowell M. Zeta,
Acting Deputy Commissioner for Policy, Legislation, and International
Affairs.
[FR Doc. 2025-21798 Filed 12-2-25; 8:45 am]
BILLING CODE 4164-01-P
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