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U.S. Food & Drug Administration
Continuing Education and Accreditation
Division of Learning and Organizational Development
Center for Drug Evaluation and Research

Overview of Expanded Access (EA) Program and EA eRequest Site

Step Status
Educational Content
Starts On: Mon, 2/14/22: 12:00 AM EST
Ends On: Tue, 12/31/24: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: Expanded Access (EA) is use of an investigational drug or biologic to treat a patient with a serious disease or condition who does not have comparable or satisfactory alternative therapies. This webinar provided an overview of FDA's EA Program and introduced participants to resources like the EA eRequest site hosted by the Reagan-Udall Foundation for the FDA. The EA eRequest site enables physicians to prepare and sign EA requests and submit those requests securely to FDA.
  • Explain the primary purpose of Expanded Access and how it differs from clinical trials.
  • Distinguish between emergency and non-emergency Expanded Access requests for individual patients.
  • Identify useful resources for preparing Expanded Access requests for individual patients.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES