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慢性髓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

2021-11-09 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,在国家药品监督管理局的部署下,药审中心组织制定了《慢性髓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

中文标题:

慢性髓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:

2021-11-09

简要介绍:

为鼓励抗肿瘤新药研发,在国家药品监督管理局的部署下,药审中心组织制定了《慢性髓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查同意,现予发布,自发布之日起施行。

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    2021-11-21 茜14D

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    2021-11-20 微探

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