重组人凝血因子Ⅷ/IX制品临床研究技术指导原则(征求意见稿)

2018-07-03 国家药品监督管理局药品审评中心(CDE) CDE

为了规范和指导重组人凝血因子Ⅷ/IX制品的研发,加快重组凝血因子Ⅷ/IX制品上市。在前期调研的基础上,起草《重组人凝血因子Ⅷ制品临床研究技术指导原则》、《重组人凝血因子Ⅸ制品临床研究技术指导原则》。

中文标题:

重组人凝血因子Ⅷ/IX制品临床研究技术指导原则(征求意见稿)

发布日期:

2018-07-03

简要介绍:

为了规范和指导重组人凝血因子Ⅷ/IX制品的研发,加快重组凝血因子Ⅷ/IX制品上市。在前期调研的基础上,起草《重组人凝血因子Ⅷ制品临床研究技术指导原则》、《重组人凝血因子Ⅸ制品临床研究技术指导原则》。

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#插入话题
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    2021-09-30 13f0c37dm61暂无昵称

    谢谢分享。

    0

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    2020-10-03 ms7000000609133913

    指南给了我们很多好的方向

    0