1. Home
  2. News & Events
  3. FDA Meetings, Conferences and Workshops
  4. Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks - 02/05/2026
  1. FDA Meetings, Conferences and Workshops

Workshop | Mixed

Event Title
Advancing the Development of Pediatric Therapeutics (ADEPT) 10: Addressing Challenges in Neonatal Product Development – Leveraging Rare Disease Frameworks
February 5 - 6, 2026

Date:
February 5 - 6, 2026
Day1:
Thu, Feb 05 1:30 p.m. - 05:00 p.m. ET
Day2:
Fri, Feb 06 8:30 a.m. - 04:00 p.m. ET
Location:
Event Location
White Oak Campus: The Great Room
Conference Center

10903 New Hampshire Ave
Building 31, Room 1503
Silver Spring, MD 20993
United States


OTP Workshop

 

On This Page:

Meeting Information:

Summary  |  Topics for Discussion  |  Attendance Information  |  Registration  |  Visiting the FDA Campus | Event Materials

Summary

The Food and Drug Administration (FDA), in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (MCERSI), is announcing the following public workshop titled "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.  

Topics for Discussion

The specific topics for discussion at this workshop include, but are not limited to, the following: 

  • Identifying common challenges in neonatal and rare disease product development.
  • Discussing ethical considerations relevant to neonatal and rare disease product development.
  • Identifying opportunities to leverage rare disease tools and strategies for neonatal conditions. 
  • Discussing the regulatory landscape of rare disease programs/resources and their application to neonatal conditions.

Attendance Information

This workshop will be held in-person on the FDA White Oak campus and in a virtual format via Zoom. Registration is required to attend. The workshop will be available for virtual viewing via Zoom on the days of the workshop. All information will be sent to attendees prior to the workshop.

Registration

Registration is free and based on space availability for in-person attendance, with priority given to early registrants. Please be prepared to provide complete contact information for each attendee, including name, email address, and affiliation when registering. Registration is required for both in-person and virtual attendance. In-person and virtual registrants will receive an email confirmation after they register. To register for the workshop, please use this link: https://fda.zoomgov.com/webinar/register/WN_2f6E6U6HSzGdpgcUxC05Hg.

  • Online registration for in-person attendance will remain open until 11:59 p.m. Eastern Standard Time on Tuesday, February 3rd, 2026. 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 first day of the public meeting (Thursday, February 5th, 2026) will be provided beginning at 11:00 a.m. We will post a notice on the meeting web page if registration for in-person attendance closes before the first day of the public meeting. Campus visitor information will be sent to in-person attendees prior to the workshop.
  • Registration for virtual attendance will be available until 12:00 p.m. Eastern Standard Time on Thursday, February 5th, 2026.

Special Accommodations

The FDA will make every effort to accommodate persons with physical disabilities or special needs at public meetings. If you require accommodations due to a disability, email OPT@fda.hhs.gov at least 7 days before to the workshop. The FDA White Oak campus and FDA shuttle are generally accessible to people with physical disabilities.

Visiting the FDA Campus

Entrance for meeting attendees (non-FDA employees) is through Building 1. All attendees (FDA and non-FDA) meeting in-person will be required to pass through routine security screening. Laptops, tablets, cell phones, keys, car fobs, coins and other metal items must be removed from pockets and put in a bin or tray for X-ray screening.

Visitors to White Oak campus can use public transportation (Metro train and bus, commuter trains and buses) or taxi and ridesharing services. Limited visitor parking is available. Please allow at least 15 minutes to get from the visitor's parking lots to Building 1 and extra time to accommodate the security check-in. After passing through security screening, attendees will be directed to the workshop room in Building 31.

For additional parking and security information, please refer to Public Meeting Information, Getting to the FDA, and Visitor Parking and Campus Map. 
 

Contact

For additional information about this workshop, contact Marianne Noone at OPT@fda.hhs.gov.
 

Event Materials

Title File Type/Size
ADEPT10 Meeting Workshop Agenda Feb 5, 2026.pdf pdf (108.71 KB)
Back to Top