priority review
...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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优先审评资格 Priority Review
优先审评券 PRV
优先评审 priority review
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。
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;
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