异种移植：监管挑战
Xenotransplantation: regulatory challenges.
作者信息
Bloom E T
机构信息
Division of Cellular and Gene Therapies (HFM-518), Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, 20852, Rockville, MD, USA.
出版信息
Curr Opin Biotechnol. 2001 Jun;12(3):312-6. doi: 10.1016/s0958-1669(00)00218-4.
Abstract
During 1999-2000, the US government published three xenotransplantation policy/guidance documents, one by the Public Health Service and two by the Food and Drug Administration (FDA). The FDA also held two public meetings of the xenotransplantation subcommittee of the Biological Response Modifiers Advisory Committee to discuss particular issues in xenotransplantation.
摘要
1999年至2000年期间，美国政府发布了三份异种移植政策/指导文件，一份由公共卫生服务局发布，两份由食品药品监督管理局（FDA）发布。FDA还召开了生物反应调节剂咨询委员会异种移植小组委员会的两次公开会议，以讨论异种移植中的特定问题。
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