Expanded Access: Insights & Resources

August 18, 2026 | 2pm (eastern)

About the Webinar

This informational webinar offered a “101-level” overview of how the expanded access process works. Through presentations and a moderated panel discussion, speakers shared practical information, real-world experiences, and resources for navigating the expanded access process. Attendees learned 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

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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.
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PhRMA provided funding for this webinar