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Ethical and Policy Challenges for Performing Xenotransplants under the FDA’s Expanded Access/Compassionate Use Pathway
Monday, September 23, 2024 at 2:00 p.m. ET
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.
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