监管政策对美国体细胞疗法发展的影响。

The impact of regulatory policy on the development of somatic cell therapies in the United States.

作者信息

Gee Adrian P

机构信息

Center For Cell and Gene Therapy, Baylor College of Medicine, Feigin Center, Houston, TX 77030, USA.

出版信息

Transpl Immunol. 2002 May;9(2-4):295-300. doi: 10.1016/s0966-3274(02)00012-6.

DOI:10.1016/s0966-3274(02)00012-6

PMID:12180844

Abstract

Cellular therapies offer new promise for the treatment of a variety of diseases. In order to protect patients and donors, the Food and Drug Administration in the USA has been developing specific regulations. These have undergone several iterations, however, a broad-based strategy has recently emerged. These proposals are reviewed and their impact on academic institutions is assessed.

摘要

细胞疗法为多种疾病的治疗带来了新希望。为了保护患者和捐赠者，美国食品药品监督管理局一直在制定具体法规。这些法规已经历了多次修订，不过，最近出现了一项基础广泛的策略。本文对这些提议进行了综述，并评估了它们对学术机构的影响。