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Xenotransplantation Products Makers Should Not Be Strangers To FDA Rules

This article was originally published in The Gray Sheet

Executive Summary

Manufacturers and clinical investigators of products derived from human and animal tissues should pay special attention to FDA rules and ensure that human research subjects give their full informed consent, according to Philip Noguchi, MD, head of the Division of Cellular and Gene Therapies in the Office of Therapeutics Research and Review at FDA's Center for Biologics Evaluation and Research.
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