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

摘要

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