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Accelerated approvals: Early-phase success or premature authorization?
Cancer Cell ( IF 48.8 ) Pub Date : 2024-10-10 , DOI: 10.1016/j.ccell.2024.09.005
Xiangyun Mao, G. Caleb Alexander, Guanqiao Li

We compare the clinical trial success rates of products receiving US Food and Drug Administration (FDA) accelerated approval (AA) to those approved without using this pathway. Our findings raise important questions about how the AA pathway can best optimize early access to therapeutics that are ultimately proven safe and effective.

中文翻译:


加速审批:早期成功还是过早授权?



我们将获得美国食品药品监督管理局 (FDA) 加速批准 (AA) 的商品与未使用此途径获得批准的商品的临床试验成功率进行了比较。我们的研究结果提出了关于 AA 途径如何最好地优化最终被证明安全有效的治疗的早期可及性的重要问题。
更新日期:2024-10-10
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