急性淋巴细胞白血病药物临床试验中检测微小残留病的技术指导原则

2020-08-28 国家药品监督管理局药品审评中心(CDE) CDE

为鼓励抗肿瘤新药研发,进一步规范急性淋巴细胞白血病药物临床试验中微小残留病检测的应用提供可参考的技术标准,在国家药品监督管理局的部署下,药审中心组织制定了《急性淋巴细胞白血病药物临床试验中检测微小残留

中文标题:

急性淋巴细胞白血病药物临床试验中检测微小残留病的技术指导原则

发布日期:

2020-08-28

简要介绍:

为鼓励抗肿瘤新药研发,进一步规范急性淋巴细胞白血病药物临床试验中微小残留病检测的应用提供可参考的技术标准,在国家药品监督管理局的部署下,药审中心组织制定了《急性淋巴细胞白血病药物临床试验中检测微小残留病的技术指导原则》(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核同意,现予发布,自发布之日起施行。
       特此通告。
                                                                                                                           国家药品监督管理局药品审评中心
                                                                                                                                         2020年8月28日

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    2020-12-31 oo902

    急性淋巴细胞白血病药物临床试验中检测微小残留病的技术指导原则

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    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

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