Notice2023-19405
Endpoints and Trial Designs To Advance Drug Development in Kidney Transplantation; Public Meeting
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
September 8, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the following public meeting on "Endpoints and Trial Designs To Advance Drug Development in Kidney Transplantation."
Full Text
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<title>Federal Register, Volume 88 Issue 173 (Friday, September 8, 2023)</title>
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[Federal Register Volume 88, Number 173 (Friday, September 8, 2023)]
[Notices]
[Pages 62096-62097]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-19405]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-N-3137]
Endpoints and Trial Designs To Advance Drug Development in Kidney
Transplantation; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following public meeting on ``Endpoints and Trial Designs To Advance
Drug Development in Kidney Transplantation.''
DATES: The public meeting will be held on November 9, 2023, from 8 a.m.
to 4:30 p.m. Eastern Time. See the SUPPLEMENTARY INFORMATION section
for registration date and information.
ADDRESSES: The public meeting will be held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993-0002. 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>.
FOR FURTHER INFORMATION CONTACT: Ozlem Belen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave, Bldg. 22, Rm. 6118, Silver Spring, MD 20993-0002, 301-
796-0676.
SUPPLEMENTARY INFORMATION:
I. Background
The goal of this public meeting is to facilitate discussion among
FDA, academicians, and industry representatives on endpoint and trial
designs to promote drug development in kidney transplantation. The last
drug FDA approved for use in prophylaxis of organ rejection in kidney
transplant was belatacept in 2011. It is well established that kidney
transplantation offers a clear survival and quality-of-life advantage
to patients with end-stage kidney disease. The current treatment
options have resulted in excellent short-term graft and patient
survival but not without long-term side effects. FDA recognizes the
importance of offering safe and effective drugs with a tolerable
adverse effect profile to preserve kidney allografts for patients. This
public meeting aims to discuss current and future potential endpoints
and trial designs that can promote development in this area of unmet
need.
II. Topics for Discussion at the Public Meeting
The topics of discussion include:
<bullet> Efficacy endpoints for prophylaxis of kidney transplant
rejection trials: current state of primary endpoints and future
potential endpoints.
<bullet> Biopsy proven acute rejection efficacy failure: long-term
impact, impact of treatment, and grade of rejection.
<bullet> Noninferiority trials: identifying clinically important
noninferiority margin, safety, and secondary efficacy endpoints.
<bullet> Enrichment as a tool in trial design: identifying target
populations.
III. Attending the Public Meeting
Registration: If you wish to attend the public meeting (either in
person or via Zoom), please register by October 26, 2023, at 4 p.m.
Eastern Time. Visit the registration page here: <a href="https://kidney-transplantation-workshop.eventbrite.com">https://kidney-transplantation-workshop.eventbrite.com</a>.
Registration is free and based on space availability, with priority
given to early registrants. Early registration is recommended because
seating is limited; therefore, FDA may limit the number of participants
from each organization. If time and space permit, onsite registration
on the day of the public meeting will be provided beginning at 7:30
a.m. Eastern Time. We will let registrants know if registration closes
before the day of the public meeting/public workshop.
If you need special accommodations due to a disability, please
contact <a href="/cdn-cgi/l/email-protection#034c4d475376616f6a604e5744507673736c7177436567622d6b6b702d646c75"><span class="__cf_email__" data-cfemail="2867666c785d4a44414b657c6f7b5d5858475a5c684e4c490640405b064f475e">[email protected]</span></a> no later than October 18, 2023.
Streaming Webcast of the Public Meeting: This public meeting will
also be virtual via Zoom. Zoom links will be sent using the email
provided by persons who register. We will post a link to the archived
recording on <a href="http://wcms-internet.fda.gov/drugs/news-events-human-drugs/endpoints-and-trial-designs-advance-drug-development-kidney-transplantation-11092023?check_logged_in=1">http://wcms-internet.fda.gov/drugs/news-events-human-drugs/endpoints-and-trial-designs-advance-drug-development-kidney-transplantation-11092023?check_logged_in=1</a>
[[Page 62097]]
approximately 1 week after the public meeting.
FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
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>. A link to the transcript will also be available at
<a href="https://www.fda.gov/about-fda/office-immunology-and-inflammation-division-rheumatology-and-transplant-medicine-drtm">https://www.fda.gov/about-fda/office-immunology-and-inflammation-division-rheumatology-and-transplant-medicine-drtm</a>.
Dated: September 1, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-19405 Filed 9-7-23; 8:45 am]
BILLING CODE 4164-01-P
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