Notice2025-18273
Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development-Leveraging Rare Disease Frameworks; 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 22, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) is announcing the following public workshop entitled "Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development--Leveraging Rare Disease Frameworks." The aim of the public workshop is to discuss common challenges in neonatal and rare disease product development and identify opportunities to leverage rare disease product development frameworks in the neonatal product development space.
Full Text
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<title>Federal Register, Volume 90 Issue 181 (Monday, September 22, 2025)</title>
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[Federal Register Volume 90, Number 181 (Monday, September 22, 2025)]
[Notices]
[Page 45388]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-18273]
[[Page 45388]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2025-N-3623]
Advancing the Development of Pediatric Therapeutics (ADEPT) 10:
Addressing Challenges in Neonatal Product Development--Leveraging Rare
Disease Frameworks; Public Meeting
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop.
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SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
following public workshop entitled ``Advancing the Development of
Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal
Product Development--Leveraging Rare Disease Frameworks.'' The aim of
the public workshop is to discuss common challenges in neonatal and
rare disease product development and identify opportunities to leverage
rare disease product development frameworks in the neonatal product
development space.
DATES: The public workshop will be held on Wednesday, December 10,
2025, 1:00 p.m.--5:00 p.m. Eastern Time, and Thursday, December 11,
2025, from 8:30 a.m. until 4:00 p.m. Eastern Time. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.
ADDRESSES: The public workshop on December 10 and 11, 2025, will be
held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. Additionally, the meeting will be streamed online on both dates.
Entrance for in-person registered public workshop 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> and
<a href="https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map">https://www.fda.gov/about-fda/visitor-information/visitor-parking-and-campus-map</a>.
FOR FURTHER INFORMATION CONTACT: Marianne Noone, the Office of
Pediatric Therapeutics, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993, 301-796-7495, <a href="/cdn-cgi/l/email-protection#b6f9e6e2f6d0d2d798dedec598d1d9c0"><span class="__cf_email__" data-cfemail="a5eaf5f1e5c3c1c48bcdcdd68bc2cad3">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
Since 2014, FDA has hosted an annual public workshop focused on
Advancing the Development of Pediatric Therapeutics (ADEPT). The ADEPT
Workshops offer opportunities for stakeholders to meet to discuss
challenging scientific issues related to pediatric product development
and pediatric regulatory science. The primary aims of ADEPT Workshops
are to:
<bullet> Discuss advancements in pediatric therapeutics
development;
<bullet> Identify gaps in current knowledge and explore innovative
approaches to address those gaps; and
<bullet> Provide a platform for open dialogue between regulators,
industry, academia, and patient organizations.
II. Topics for Discussion at the Public Workshop
The specific topics for discussion at this workshop include, but
are not limited to, the following:
<bullet> identifying common challenges in neonatal and rare disease
product development;
<bullet> discussing ethical considerations relevant to neonatal and
rare disease product development;
<bullet> identifying opportunities to leverage rare disease tools
and strategies for neonatal conditions; and
<bullet> discussing the regulatory landscape of rare disease
programs/resources and their application to neonatal conditions.
III. Participating in the Public Workshop
Registration: To register for the public workshop, please visit the
following website: <a href="https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/advancing-development-pediatric-therapeutics-adept-10-addressing-challenges-neonatal-product">https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/advancing-development-pediatric-therapeutics-adept-10-addressing-challenges-neonatal-product</a>. Please provide
complete contact information for each attendee, including name, email
address, and affiliation.
Registration is free and based on space availability, with priority
given to early registrants. Persons interested in attending this public
workshop in-person must register by December 9, 2025, at 12:00 p.m.
Eastern Time; virtual attendees may register by December 10, 2025, at
12:00 p.m., Eastern Time. 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 first day of the public workshop (December
10, 2025) will be provided beginning at 11:00 a.m. We will let
registrants know if registration closes before the day of the public
workshop.
If you need special accommodations due to a disability, please
contact <a href="/cdn-cgi/l/email-protection#dd928d899dbbb9bcf3b5b5aef3bab2ab"><span class="__cf_email__" data-cfemail="551a0501153331347b3d3d267b323a23">[email protected]</span></a> no later than November 26, 2025.
If you have never attended a Zoom event before, test your
connection at <a href="https://zoom.us/test">https://zoom.us/test</a>. Although FDA verified the website
addresses in this document, please note that websites are subject to
change over time.
Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible on the workshop
website: <a href="https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/advancing-development-pediatric-therapeutics-adept-10-addressing-challenges-neonatal-product">https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/advancing-development-pediatric-therapeutics-adept-10-addressing-challenges-neonatal-product</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. 2025-18273 Filed 9-19-25; 8:45 am]
BILLING CODE 4164-01-P
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