Notice2026-10703
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application; Guidance for Industry; Availability
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Published
May 29, 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 entitled "Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA." This guidance provides recommendations to applicants planning to include bioequivalence (BE) information in abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA supplements. In addition, this guidance describes how to meet the BE requirements set forth in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations. This guidance finalizes the draft guidance for industry of the same title issued on August 23, 2021.
Full Text
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<title>Federal Register, Volume 91 Issue 103 (Friday, May 29, 2026)</title>
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[Federal Register Volume 91, Number 103 (Friday, May 29, 2026)]
[Notices]
[Pages 32057-32059]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10703]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-D-1464]
Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs
Submitted Under an Abbreviated New Drug Application; 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 final guidance for industry entitled
``Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs
Submitted Under an ANDA.'' This guidance provides recommendations to
applicants planning to include bioequivalence (BE) information in
abbreviated new drug applications (ANDAs), ANDA amendments, and ANDA
supplements. In addition, this guidance describes how to meet the BE
requirements set forth in the Federal Food, Drug, and Cosmetic Act
(FD&C Act) and FDA regulations. This guidance finalizes the draft
guidance for industry of the same title issued on August 23, 2021.
DATES: The announcement of the guidance is published in the Federal
Register on May 29, 2026.
ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:
[[Page 32058]]
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-2013-D-1464 for ``Bioequivalence Studies With Pharmacokinetic
Endpoints for Drugs Submitted Under an ANDA.'' 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 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: David Coppersmith, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1666, Silver Spring, MD 20903, 301-796-
9193, <a href="/cdn-cgi/l/email-protection#95d1f4e3fcf1bbd6fae5e5f0e7e6f8fce1fdd5f3f1f4bbfdfde6bbf2fae3"><span class="__cf_email__" data-cfemail="541035223d307a173b2424312627393d203c143230357a3c3c277a333b22">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a guidance for industry
entitled ``Bioequivalence Studies With Pharmacokinetic Endpoints for
Drugs Submitted Under an ANDA.'' This guidance provides recommendations
to applicants planning to include BE information in ANDAs, ANDA
amendments, and ANDA supplements. In addition, this guidance describes
how to meet the BE requirements set forth in the FD&C Act and FDA
regulations. This guidance is applicable to immediate-release and
modified-release oral dosage forms. It is also applicable to non-orally
administered drug products in which reliance on systemic exposure
measures is suitable for establishing BE (e.g., transdermal delivery
systems and certain rectal and nasal drug products). This guidance will
also be useful to applicants planning BE studies intended to be
conducted during the postapproval period for changes to a drug product
approved under an ANDA.
This guidance finalizes the draft guidance for industry of the same
title issued on August 23, 2021 (86 FR 47117). FDA considered comments
received on the draft guidance as the guidance was finalized. Changes
from the draft to the final guidance include: (1) updates to align the
recommendations in the guidance with the recommendations in the
guidance for industry entitled ``M13A Bioequivalence for Immediate-
Release Solid Oral Dosage Forms'' issued on October 31, 2024, (2)
clarifications about study population and study design, (3) updates to
in vitro dissolution testing information, and (4) removal of the
appendices on the statistical analysis for the reference scaled average
BE for narrow therapeutic index drugs and highly variable drugs, which
were incorporated into the guidance for industry entitled ``Statistical
Approaches to Establishing Bioequivalence'' issued concurrently with
this guidance. 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 ``Bioequivalence Studies With
Pharmacokinetic Endpoints for Drugs Submitted Under an ANDA.'' 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 neither regulatory nor
deregulatory.
[[Page 32059]]
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 parts 50 and 56 relating to the protection of human subjects
and investigational review boards have been approved under OMB control
number 0910-0130. The collections of information in 21 CFR 201.56 and
201.57 for the Requirements on Content and Format of Labeling for Human
Prescription Drug and Biological Products have been approved under OMB
control number 0910-0572. The collections of information in 21 CFR part
312 relating to the submission of investigational new drug applications
and bioavailability/BE (BA/BE) studies or pharmacogenomic data and the
collections of information in part 320 for drug safety reporting have
been approved under OMB control numbers 0910-0014 and 0910-0291. The
collections of information under 21 CFR part 312.145 pertaining to good
clinical practice have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 relating to the
submission of new drug applications, ANDAs, and supplemental
applications and applicable BA/BE requirements have been approved under
OMB control number 0910-0001. The collections of information under the
administrative practices and procedures for petitions, hearings, and
other administrative proceedings and activities conducted by the FDA
under 21 CFR part 10 and 12 are approved under OMB control number 0910-
0191. The collections of information for the submission of controlled
correspondence, and for meetings pertaining to ANDA approval are
approved under OMB control number 0910-0727. The collections of
information pertaining to Good Laboratory Practice Regulations have
been approved under OMB control number 0910-0119.
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>.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10703 Filed 5-28-26; 8:45 am]
BILLING CODE 4164-01-P
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