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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

An Overview of FDA’s Project Facilitate Oncology Expanded Access Program

Step Status
Educational Content
Starts On: Wed, 2/14/24: 12:00 AM EST
Ends On: Sat, 2/13/27: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: Expanded access, sometimes called "compassionate use", is a potential pathway for a patient 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. This enduring material will review the oncology expanded access pathway and Project Facilitate's role in making oncology expanded access more accessible for healthcare and regulatory professionals.
  • Define expanded access and the key requirements for an expanded access request for an individual patient.
  • Summarize the key responsibilities of the oncology healthcare professional when considering expanded access for a patient.
  • Identify resources available to healthcare professionals considering submission of an oncology expanded access request for an individual patient.
  • Describe how Project Facilitate is a resource to navigate the oncology Expanded Access pathway.
Additional Information: Review the Activity Announcement for additional details: Announcement Form

Additional Resources: SLIDES