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PubMed

Regulating cell and xeno-transplants: Learning from medical device oversight.

PMID: 42722334 ·

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JournalAmerican journal of transplantation : official journal of the American Society of Transplantation and the American Society of Transplant Surgeons
Year
PMID42722334

Abstract

The widespread availability of genetically engineered cellular products and organs for xenotransplantation could address the persistent shortage of human donor organs, but the current regulatory framework, which was originally designed for discrete molecular entities, is poorly suited to the paradigm of innovation in this field. The US Food and Drug Administration requires sponsors to file investigational new drug applications and pursue a Biologics License Application built around a binary, one

Official Source

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