Ethical and Policy Challenges for Performing Xenotransplants under the FDA’s Expanded Access/Compassionate Use Pathway

Focuses on ethical and policy challenges for performing xenotransplants under the U.S. Food and Drug Administration’s Expanded Access/Compassionate Use program.

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About this Webinar

This webinar focuses on ethical and policy challenges for performing xenotransplants under the U.S. Food and Drug Administration’s Expanded Access/Compassionate Use program. It explains how this program allows patients to get access to an investigational drug/biologic when certain conditions are met and describes the four xenotransplants that were performed under this program. The webinar also identifies ethical concerns about informed consent for patients obtaining a xenotransplant under the expanded access/compassionate pathway and describes ethical and policy implications of expanded access/compassionate use xenotransplants for first-in-human xenotransplant clinical trials.

Release Date: February 26, 2025

Language Availability: English

Suggested Audiences: Clinicians, Postdocs, Research Personnel, Researchers, Students

Organizational Subscription Price: Included as part of an annual subscription to our All Access Webinar Package
Independent Learner Price: $49 per person


Webinar Content

Ethical and Policy Challenges for Performing Xenotransplants under the FDA’s Expanded Access/Compassionate Use Pathway

Elisa J. Gordon, PhD, MPH – Vanderbilt University Medical Center; Michael K. Gusmano, PhD – Lehigh University; Karen J. Maschke, PhD – The Hastings Center

Learning Objectives:

  • Define the U.S. Food and Drug Administrations (FDA’s) expanded access/compassionate use pathway for patient access to investigational medical product (drug, biologic, or medical device).
  • Describe the xenotransplants that were performed using the expanded access/compassionate use pathway.
  • Identify ethical concerns about informed consent for patients obtaining a xenotransplant under the expanded access/compassionate pathway.
  • Describe ethical and policy implications of expanded access/compassionate use xenotransplants for first-in-human xenotransplant clinical trials.

Recommended Use: Required
ID (Language): 21231 (English)


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