Notice2026-08524
Impacts of Patient-Focused Drug Development Meetings; Establishment of a Public Docket; Request for Information and 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 1, 2026
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, the Agency, or we) is establishing a public docket to collect examples about how previous patient-focused drug development (PFDD) meetings have impacted stakeholders' drug development efforts. This includes impacts on community engagement, research priorities, advocacy strategies, medical product development programs, clinical practice, and other areas of interest.
Full Text
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<title>Federal Register, Volume 91 Issue 84 (Friday, May 1, 2026)</title>
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[Federal Register Volume 91, Number 84 (Friday, May 1, 2026)]
[Notices]
[Pages 23426-23427]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-08524]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2026-N-3947]
Impacts of Patient-Focused Drug Development Meetings;
Establishment of a Public Docket; Request for Information and Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice; establishment of a public docket; request for
information and comments.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
establishing a public docket to collect examples about how previous
patient-focused drug development (PFDD) meetings have impacted
stakeholders' drug development efforts. This includes impacts on
community engagement, research priorities, advocacy strategies, medical
product development programs, clinical practice, and other areas of
interest.
DATES: Either electronic or written comments on the notice must be
submitted by June 30, 2026
ADDRESSES: 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 June 30, 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-3947 for ``Impacts of Patient-Focused Drug Development
Meetings; Establishment of a Public Docket; Request for Information and
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 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
[[Page 23427]]
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#cb8ebfa3aaa5e58caaa9a9a4beb98badafaae5a3a3b8e5aca4bd"><span class="__cf_email__" data-cfemail="92d7e6faf3fcbcd5f3f0f0fde7e0d2f4f6f3bcfafae1bcf5fde4">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
As directed by Section 569C of the Federal Food, Drug, and Cosmetic
Act, as amended by Section 3001 of the 21st Century Cures Act (Pub. L.
114-255), FDA has developed and implemented strategies to obtain
patient input to inform drug development and regulatory decision-
making. FDA-led PFDD and externally led-PFDD (EL-PFDD) meetings provide
a structured opportunity to hear directly from patients, caregivers,
family members, and patient advocates. These meetings center on the
aspects of a disease or condition and its treatment that are most
meaningful to patients, including symptoms, effects on daily life, and
experiences with available therapies.
Patient input from these meetings can inform medical product
development, research priorities, and regulatory oversight. In response
to stakeholder requests to better understand the outcomes of these
meetings, FDA is seeking to collect information about their subsequent
impacts. The Agency recognizes that many significant outcomes such as
interactions within patient communities, between patient groups and
medical product developers, or among clinicians occur in forums to
which FDA is not typically a party. Similarly, changes made by medical
product developers in response to patient input may not be communicated
to FDA outside of a formal regulatory submission.
II. Issues for Consideration and Request for Information
FDA is issuing this request for information to gain a better
understanding of how patient input from FDA-led PFDD and EL-PFDD
meetings has informed stakeholder activities including research,
product development, and patient care, outside of specific regulatory
decisions. FDA invites input from all interested parties, including
patient organizations, medical product developers, healthcare
providers, and academic researchers.
FDA is seeking information that addresses the following:
1. How have PFDD meetings informed patient communities and
stakeholder engagement activities?
2. What scientific questions, research initiatives, or identified
gaps in the understanding of a disease or condition have resulted from
PFDD meetings?
3. In what ways has patient input from PFDD meetings informed
medical product development programs or strategies (e.g., endpoint
development, clinical trial design, identification of unmet needs,
industry partnerships)?
4. How has patient input gathered during PFDD meetings been
integrated into or otherwise affected clinical practice?
5. Please describe any other outcomes or effects resulting from
PFDD meetings, with examples, that were not addressed in the questions
above.
FDA encourages respondents to provide specific examples in their
answers where possible.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2026-08524 Filed 4-30-26; 8:45 am]
BILLING CODE 4164-01-P
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