Notice2025-22131
Product-Specific Guidances; Draft and Revised Draft Guidances 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
December 5, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of additional draft and revised draft product-specific guidances. The draft guidances provide product- specific recommendations on, among other things, the design of bioequivalence (BE) studies to support abbreviated new drug applications (ANDAs). In the Federal Register of June 11, 2010, FDA announced the availability of a guidance for industry entitled "Bioequivalence Recommendations for Specific Products" that explained the process that would be used to make product-specific guidances available to the public on FDA's website. The draft guidances identified in this notice were developed using the process described in that guidance.
Full Text
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<title>Federal Register, Volume 90 Issue 232 (Friday, December 5, 2025)</title>
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[Federal Register Volume 90, Number 232 (Friday, December 5, 2025)]
[Notices]
[Pages 56161-56163]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-22131]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2007-D-0369]
Product-Specific Guidances; Draft and Revised Draft Guidances for
Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of additional draft and revised draft
product-specific guidances. The draft guidances provide product-
specific recommendations on, among other things, the design of
bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs). In the Federal Register of June 11, 2010, FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website. The draft guidances
identified in this notice were developed using the process described in
that guidance.
DATES: Submit either electronic or written comments on the draft
guidance by February 3, 2026 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 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-2007-D-0369 for ``Product-Specific Guidances; Draft and Revised
Draft Guidances for Industry.'' 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
[[Page 56162]]
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. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Joseph Kotsybar, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 3623A, Silver Spring, MD 20993-0002, 240-
402-1062, <a href="/cdn-cgi/l/email-protection#c7979480ea96b2a2b4b3aea8a9b487a1a3a6e9afafb4e9a0a8b1"><span class="__cf_email__" data-cfemail="8ddddecaa0dcf8e8fef9e4e2e3fecdebe9eca3e5e5fea3eae2fb">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of June 11, 2010 (75 FR 33311), FDA
announced the availability of a guidance for industry entitled
``Bioequivalence Recommendations for Specific Products'' that explained
the process that would be used to make product-specific guidances
available to the public on FDA's website 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>.
As described in that guidance, FDA adopted this process to develop
and disseminate product-specific guidances and provide a meaningful
opportunity for the public to consider and comment on those guidances.
Under that process, draft guidances are posted on FDA's website and
announced periodically in the Federal Register. The public is
encouraged to submit comments on those recommendations within 60 days
of their announcement in the Federal Register. FDA considers any
comments received and either publishes final guidances or publishes
revised draft guidances for comment. Guidances were last announced in
the Federal Register on November 21, 2025 (90 FR 223). This notice
announces draft product-specific guidances, either new or revised, that
are posted on FDA's website.
II. Drug Products for Which New Draft Product-Specific Guidances Are
Available
FDA is announcing the availability of new draft product-specific
guidances for industry for drug products containing the following
active ingredients:
Table 1--New Draft Product-Specific Guidances for Drug Products
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Active ingredient(s)
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Acoramidis hydrochloride
Apomorphine hydrochloride
Arimoclomol citrate
Birch triterpenes
Bupropion hydrochloride; Dextromethorphan hydrobromide
Cabergoline
Cefepime hydrochloride; Enmetazobactam
Crinecerfont (multiple reference listed drugs)
Desmopressin acetate
Deutivacaftor; Tezacaftor; Vanzacaftor calcium
Docetaxel
Elafibranor
Elexacaftor, Ivacaftor, Tezacaftor; Ivacaftor
Ensartinib hydrochloride
Escitalopram oxalate
Estradiol; Norethindrone Acetate; Relugolix
Estradiol; Progesterone
Fenfluramine hydrochloride
Flurpiridaz F-18
Gepotidacin mesylate
Hydrochlorothiazide
Hydroxychloroquine sulfate
Iomeprol (multiple reference listed drugs)
Isotretinoin
Ketorolac tromethamine; Phenylephrine hydrochloride
Levacetylleucine
Omeprazole; Sodium bicarbonate
Pegulicianine acetate
Pivmecillinam hydrochloride
Potassium chloride
Prednisolone acetate
Primidone
Pyridostigmine bromide (multiple reference listed drugs)
Revumenib citrate
Roflumilast
Selpercatinib
Suzetrigine
Talazoparib tosylate
Tenapanor hydrochloride
Testosterone undecanoate
Treosulfan
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III. Drug Products for Which Revised Draft Product-Specific Guidances
Are Available
FDA is announcing the availability of revised draft product-
specific guidances for industry for drug products containing the
following active ingredients:
Table 2--Revised Draft Product-Specific Guidances for Drug Products
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Active ingredient(s)
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Baclofen
Baricitinib
Brigatinib
Budesonide (multiple reference listed drugs)
Calcitonin salmon
Carbinoxamine maleate
Carvedilol phosphate
Cenobamate
Dabrafenib mesylate
Dasiglucagon hydrochloride
Diltiazem hydrochloride
Epinephrine (multiple reference listed drugs)
Etodolac
Fluticasone propionate
Glucagon (multiple reference listed drugs)
Hydrochlorothiazide; Metoprolol tartrate
Ixazomib
Liraglutide (multiple reference listed drugs)
Mesalamine
Omeprazole; Sodium bicarbonate
Pegcetacoplan (multiple reference listed drugs)
Poscaconazole
Pyridostigmine bromide
Semaglutide
Sunitinib malate
Tapinarof
Teriparatide
[[Page 56163]]
Tirzepatide
Treprostinil
Tretinoin
Trospium chloride
Vosoritide
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For a complete history of previously published Federal Register
notices related to product-specific guidances, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and enter Docket No. FDA-2007-D-0369.
These draft guidances are being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). These draft guidances,
when finalized, will represent the current thinking of FDA on, among
other things, the product-specific design of BE studies to support
ANDAs. They do not establish any rights for any person and are 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.
IV. Paperwork Reduction Act of 1995
While these guidances contain no collection of information, they do
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
OMB under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3521).
The collections of information in 21 CFR part 312 for investigational
new drugs have been approved under OMB control number 0910-0014. The
collections of information in 21 CFR part 314 for applications for FDA
approval to market a new drug and in 21 CFR part 320 for
bioavailability and bioequivalence requirements have been approved
under OMB control number 0910-0001.
V. Electronic Access
Persons with access to the internet may obtain the draft 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. 2025-22131 Filed 12-4-25; 8:45 am]
BILLING CODE 4164-01-P
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