Expanded Access: Insights & Resources
August 18, 2026 | 2pm (eastern)
About the Webinar
This informational webinar will offer a “101-level” overview of how the expanded access process works. Through presentations and a moderated panel discussion, speakers will share practical information, real-world experiences, and resources for navigating the expanded access process. Join us to learn more about the following:
Key steps in the process
Roles of patients, providers, companies, FDA, and other stakeholders
Tools for submitting and managing an expanded access request
Expanded Access Navigator: guides patients, caregivers, and physicians through the request process
eRequest app: allows physicians and other prescribers to complete and submit single-patient requests to FDA online
Other resources available from FDA
What Is Expanded Access?
Expanded access may provide a pathway for patients with a serious or immediately life-threatening disease or condition to gain access to an investigational medical product (drug, biologic, or medical device) for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available.
Agenda
Who Should Attend
Patients, caregivers, drug developers, health care providers & institutions, policymakers, and anyone who wants to better understand expanded access
Enduring Materials
The recorded webinar and links to tools and resources will be available on the Foundation website at www.reaganudall.org.