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FDA系列指南指导防控通过细胞、组织传播的生物风险
在美国FDA监管的产品中,有一类特殊的产品,全称是人体细胞、组织以及基于细胞和组织的产品(Human Cells, Tissues, and Cellular and Tissue-Based Products,HCT/Ps)。因为这类特殊产品使用的物料部分是来自人体的细胞和组织,因此有通过人体细胞和组织传播病原微生物的风险。
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