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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

Project Facilitate: Oncology Expanded Access Program Update

Step Status
Educational Content ✘
Posttest ✘
Evaluation ✘
Starts On: Mon, 2/28/22: 12:00 AM EST
Ends On: Sun, 12/31/23: 12:00 AM EST
Type: Enduring Material
Credits: 1
Description: This webinar will discuss Expanded Access, the regulatory pathway by which an oncologist may obtain access to an investigational drug product for the purposes of treating a patient with a life-threatening medical condition for which there is no acceptable treatment. The FDA Oncology Center of Excellence's Project Facilitate was established to meet the demand for oncology Expanded Access through increasing awareness of this pathway, increasing accessibility and establishing a single point-of-contact for the public. Project Facilitate is continually improving oncology Expanded Access to ensure everyone has personalized support when submitting their application.
Objectives:
  • 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