...严重和危及生命疾病的新药、比已上市药品有显著改进的药品,根据不同特点,有三条特别审评通道: 1)优先审评(Priority Review):主要针对能够在治疗、诊断或预防疾病上比已上市药品有显著改进的药品上市申请。
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...日,Kite Pharma宣布,美国FDA为其首款CAR-T疗法axicabtagene ciloleucel的生物制剂许可申请颁发了优先审评资格(priority review),并计划于今年11月29日做出批复。
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优先评审(Priority Review)指FDA对完成某项新药评审的时间安排。新药申请(NDA’紫.“先药品..级别是FDA建到NDA后进行台格性检查时由FDA医务评审官员确定...
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...立了三种快速审批机制来加速新药审批:快速通道(Fast Track)、加速审批(Accelerated Approval)和优先审核(Priority Review)。快速通道机制用来审核对严重的疾病提供新疗法或填补治疗空缺的新药。
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Pfizer boasted that the FDA had granted “priority review” for a drug, crizotinib, that treats some types of lung cancer.
辉瑞(Pfizer)自称已获得食品及药物管理局对药品crizotinib的“优先审核”。 (crizotinib是治疗某些类型肺癌的药品)。
Almost half (16) were approved under “priority review,” in which the FDA has a six month goal to complete its review for safety and effectiveness;
几乎半数(16种)是“优先审评,”下批准其中FDA有6个月目标完成安全性和有效性审评。
Also, by sorting the issues list by priority and next review date, you get an immediate list of issues that need resolution rather than reviewing issues that have an impact later on in the project.
另外,根据重要性和下次回顾日期整理问题清单,你能得到需要紧急解决的问题清单,而不用回顾那些稍后才会影响到项目的问题。
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