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

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 paradigm, which was originally designed for discrete molecular entities, is poorly suited to the paradigm of innovation in this field. The Food and Drug Administration requires sponsors to file investigational new drug applications and pursue a Biologics License Application built around a binary, one-tim