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Erosive Esophagitis: Developing Drugs for Treatment; Draft Guidance for Industry; Availability

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Published
September 17, 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The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a draft guidance for industry entitled "Erosive Esophagitis: Developing Drugs for Treatment." The draft guidance details recommendations on clinical trials for drugs being developed for the healing of erosive esophagitis (EE) and maintenance of healed EE in adults, including considerations for eligibility criteria, trial design features, efficacy evaluations, and safety assessments.

Full Text

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<title>Federal Register, Volume 90 Issue 178 (Wednesday, September 17, 2025)</title>
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[Federal Register Volume 90, Number 178 (Wednesday, September 17, 2025)]
[Notices]
[Pages 44825-44827]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18001]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2025-D-0346]


Erosive Esophagitis: Developing Drugs for Treatment; Draft 
Guidance for Industry; Availability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, Agency, or we) is 
announcing the availability of a draft guidance for industry entitled 
``Erosive Esophagitis: Developing Drugs for Treatment.'' The draft 
guidance details recommendations on clinical trials for drugs being 
developed for the healing of

[[Page 44826]]

erosive esophagitis (EE) and maintenance of healed EE in adults, 
including considerations for eligibility criteria, trial design 
features, efficacy evaluations, and safety assessments.

DATES: Submit either electronic or written comments on the draft 
guidance by November 17, 2025 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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 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-0346 for ``Erosive Esophagitis: Developing Drugs for 
Treatment.'' 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 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: Andrew Chi, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 22, Silver Spring, MD 20993-0002, 301-796-8597.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Erosive Esophagitis: Developing Drugs for Treatment.'' The 
draft guidance provides FDA's recommendations on the design and conduct 
of clinical trials for drugs being developed for the healing of EE and 
maintenance of healed EE in adults, including considerations for 
eligibility criteria, trial design features, efficacy evaluations, and 
safety assessments. This draft guidance details endpoint assessments 
and analyses of collected data to support a determination of efficacy 
for the indications of the healing of EE and maintenance of healed EE, 
to promote consistency and interpretability in the assessment of 
efficacy within and across development programs. This draft guidance 
does not address the development of drugs for the treatment of 
symptomatic nonerosive gastroesophageal reflux disease, Barrett's 
esophagus, pathological hypersecretory conditions (e.g., Zollinger-
Ellison syndrome), peptic ulcer disease, or the development of drugs 
for healing of EE and maintenance of healed EE in pediatric patients.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the current thinking of FDA on ``Erosive 
Esophagitis: Developing Drugs for Treatment.'' 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

    This guidance refers to collections of information from 
``individuals under treatment or clinical examination in connection 
with research,'' which are not subject to review by the Office of 
Management and Budget (OMB) under 5 CFR 1320.3(h)(5). This guidance 
also refers to previously approved FDA collections of information. The 
previously approved collections of information are subject to review by 
OMB under the Paperwork Reduction

[[Page 44827]]

Act of 1995 (44 U.S.C. 3501-3521). The collections of information in 21 
CFR part 50 pertaining to protection of human subjects have been 
approved under OMB control number 0910-0130. The collections of 
information in 21 CFR part 312 pertaining to the investigational new 
drug application pathway, which includes clinical trials and clinical 
trial design, have been approved under OMB control number 0910-0014. 
The collections of information in 21 CFR part 314 pertaining to new 
drug applications have been approved under OMB control number 0910-
0001. The collections of information in 21 CFR part 601 pertaining to 
biologic license applications have been approved under OMB control 
number 0910-0338.

III. 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>.

Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-18001 Filed 9-16-25; 8:45 am]
BILLING CODE 4164-01-P


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