Conflicting signals on US accelerated approvals

被引：3
|
作者：
Fox, JL
机构：
来源：
NATURE BIOTECHNOLOGY | 2005年 / 23卷 / 09期
关键词：
D O I：
10.1038/nbt0905-1027
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
The results of a phase 3 clinical study on the lung cancer drug Iressa (gefitinib) have revealed that the drug did not produce a significant survival advantage over placebo. Since then some FDA critics contend that the accelerated review process should be slowed, whereas others fear that heightened anxieties about safety could undermine a program that provides therapeutics more quickly to needy patients.
引用
收藏
页码：1027 / 1028
页数：2
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