6 hours
FDA White Oak Campus
Free Tickets Available
Thu, 18 Sep, 2025 at 09:00 am to 03:00 pm (GMT-04:00)
FDA White Oak Campus
10903 New Hampshire Ave, White Oak, United States
Under the Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), FDA committed to piloting a regulatory science program that focuses on: 1) advancing the development of interchangeable products; and 2) improving the efficiency of biosimilar product development. For stakeholder engagement, this commitment includes publishing an interim progress report and holding an interim public meeting by October 31, 2025, approximately midway through the pilot program.
FDA will host a hybrid in-person/virtual meeting to meet the BsUFA III Commitment on September 18, 2025.
As they become available, additional information (e.g. the Federal Register notice, meeting materials) will be provided at the link: https://www.fda.gov/news-events/fda-meetings-conferences-and-workshops/fda-public-meeting-bsufa-iii-regulatory-science-program-interim-public-meeting-09182025
Visitor information for in person attendance:
https://www.fda.gov/about-fda/visitor-information
Also check out other Meetups in White Oak, Workshops in White Oak.
Tickets for BsUFA III Regulatory Science Program Interim Public Meeting can be booked here.
| Ticket type | Ticket price |
|---|---|
| Virtual | Free |
| In Person | Free |
We have gathered all the information for you in one convenient spot, but please keep in mind that these are subject to change. We do our best to keep everything updated, but something might be out of sync. For the latest updates, always check the official event details by clicking the "Find Tickets" button.
