人纤维蛋白原临床试验技术指导原则(试行)

2022-02-18 国家药品监督管理局药品审评中心(CDE) CDE

为指导和规范人纤维蛋白原用于先天性纤维蛋白原缺乏症和获得性纤维蛋白原缺乏症的临床试验,在国家药品监督管理局的部署下,药审中心组织制定了《人纤维蛋白原临床试验技术指导原则(试行)》(见附件)

中文标题:

人纤维蛋白原临床试验技术指导原则(试行)

发布日期:

2022-02-18

简要介绍:

 为指导和规范人纤维蛋白原用于先天性纤维蛋白原缺乏症和获得性纤维蛋白原缺乏症的临床试验,在国家药品监督管理局的部署下,药审中心组织制定了《人纤维蛋白原临床试验技术指导原则(试行)》(见附件)。

根据《国家药监局综合司关于印发药品技术指导原则发布程序的通知》(药监综药管〔2020〕9号)要求,经国家药品监督管理局审查同意,现予发布,自发布之日起施行。

       特此通告。

       附件:人纤维蛋白原临床试验技术指导原则(试行)

                                                                                                                                                                        国家药监局药审中心

                                                                                                                                                                            2022年2月17日

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