Notice2026-10752
Patient-Focused Drug Development for Nonhealing Chronic Wounds; Public Meeting; Request for Comments
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 29, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is announcing the following public meeting entitled "Patient-Focused Drug Development for Nonhealing Chronic Wounds." The purpose of the public meeting is to obtain patient perspectives about the impact of nonhealing chronic wounds on daily life, patient views on treatment approaches, factors to consider when selecting a treatment, and what they consider when determining whether to participate in a clinical trial.
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 32059-32060]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-10752]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-5057]
Patient-Focused Drug Development for Nonhealing Chronic Wounds;
Public Meeting; Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Patient-Focused Drug
Development for Nonhealing Chronic Wounds.'' The purpose of the public
meeting is to obtain patient perspectives about the impact of
nonhealing chronic wounds on daily life, patient views on treatment
approaches, factors to consider when selecting a treatment, and what
they consider when determining whether to participate in a clinical
trial.
DATES: The hybrid public meeting will be held on August 25, 2026, from
10:00 a.m. to 4:30 p.m., Eastern Time and will take place in person and
virtually. Either electronic or written comments on this public meeting
must be submitted by October 26, 2026. See the SUPPLEMENTARY
INFORMATION section for registration date and information.
ADDRESSES: The hybrid public meeting will be held in person at the FDA
White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center,
the Great Room, Silver Spring, MD 20993-0002, and virtually via a live
webcast. Entrance for the public meeting participants (non-FDA
employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to <a href="https://www.fda.gov/about-fda/visitor-information">https://www.fda.gov/about-fda/visitor-information</a>.
You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a>
electronic filing system will accept comments until 11:59 p.m., Eastern
Time at the end of October 26, 2026. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are received on or before that date.
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-2026-N-5057 for ``Patient-Focused Drug Development for Nonhealing
Chronic Wounds; Public Meeting; Request for Comments.'' Received
comments, those filed in a timely manner (see ADDRESSES), 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
[[Page 32060]]
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.
FOR FURTHER INFORMATION CONTACT: Ethan Gabbour, Center for Drug
Evaluation and Research, Food and Drug Administration, 301-796-8112,
<a href="/cdn-cgi/l/email-protection#7a3f0e121b14543d1b1818150f083a1c1e1b54121209541d150c"><span class="__cf_email__" data-cfemail="f5b0819d949bdbb29497979a8087b5939194db9d9d86db929a83">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
This meeting will provide FDA and other key stakeholders, including
medical product developers, health care providers, and federal
partners, the opportunity to hear directly from patients, patient
representatives, and care partners about their experiences with
nonhealing chronic wounds, including how the wounds and associated
wound care affect their daily lives, what matters most to them, their
current approaches to managing or treating their nonhealing chronic
wounds, and what they consider when determining whether to participate
in a clinical trial. Chronic wounds are defined as wounds that have
failed to proceed through an orderly and timely series of events to
produce a functional, durable, and cosmetic closure. When standard of
care has been applied to a wound with failure to progress towards
healing within 4 weeks, that wound is generally considered chronic.
These wounds most commonly occur on the feet and lower legs. They are
more prevalent in individuals with underlying conditions such as
diabetes, malnutrition, connective tissue diseases, poor circulation,
or compromised immune systems. They can cause lasting pain, sleep
difficulties, limited movement, and depression. Existing management of
wounds primarily consists of wound dressings and medical devices that
target the body's natural healing process. However, the exact
management or treatment protocol is based on the type of wound and its
underlying cause.
For each topic, a brief discussion by a patient panel will begin
the dialogue. This discussion will be followed by a facilitated
discussion inviting comments from patients, patient representatives,
and care partners.
In addition to input generated through this public meeting, FDA is
interested in receiving patient and patient representative input
through written comments, which can be submitted to the public docket
(see ADDRESSES). When submitting comments, if you are commenting on
behalf of a patient, please indicate that you are doing so, and answer
the questions as much as possible from the patient perspective.
FDA will post the agenda and other meeting materials approximately
5 days before the meeting at: <a href="https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds">https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds</a>.
II. Topics for Discussion at the Public Meeting
On August 25, 2026, FDA will conduct a public meeting entitled
``Patient-Focused Drug Development for Nonhealing Chronic Wounds.'' FDA
is interested in obtaining patient and care partner perspectives on the
impact of nonhealing chronic wounds on daily life, on approaches to
treat such wounds, and on considerations for clinical trial
participation.
III. Participating in the Public Meeting
Registration: To register for the public meeting, please visit the
following website: <a href="https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds">https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds</a>. Please indicate either in-person or virtual
attendance, and provide complete contact information for each attendee,
including name, affiliation, and email.
Registration is free for both in-person and virtual attendance. In-
person attendance is based on space availability, with priority given
to early registrants. Persons interested in attending this public
meeting in person must register by August 23, 2026, 11:59 p.m., Eastern
Time. Virtual attendees can register and join at any time through the
conclusion of the meeting. Early registration for in-person attendance
is recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public meeting will be provided
beginning at 10:00 a.m. We will let registrants know if registration
closes before the day of the public meeting.
If you need special accommodations due to a disability, please
contact <a href="/cdn-cgi/l/email-protection#d396a7bbb2bdfd94b2b1b1bca6a193b5b7b2fdbbbba0fdb4bca5"><span class="__cf_email__" data-cfemail="9adfeef2fbf4b4ddfbf8f8f5efe8dafcfefbb4f2f2e9b4fdf5ec">[email protected]</span></a> no later than August 18, 2026. Please
note that closed captioning will be available for online attendees.
Streaming Webcast of the Public Meeting: This public meeting will
also be webcast. Please register for the webcast by visiting <a href="https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds">https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds</a>.
This webcast can also be accessed via: <a href="https://www.zoomgov.com/j/1657415115?pwd=9aZFuJFfpDVCQ99WWLjoByKzYDwBRS.1">https://www.zoomgov.com/j/1657415115?pwd=9aZFuJFfpDVCQ99WWLjoByKzYDwBRS.1</a>.
Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at <a href="https://www.regulations.gov">https://www.regulations.gov</a>. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at <a href="https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds">https://www.fda.gov/drugs/news-events-human-drugs/fda-public-meeting-fda-led-patient-focused-drug-development-meeting-nonhealing-chronic-wounds</a>.
Notice of this meeting is given pursuant to 21 CFR 10.65.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-10752 Filed 5-28-26; 8:45 am]
BILLING CODE 4164-01-P
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