The US Food and Drug Administration's expedited approval programs: Addressing premarket flexibility with enhanced postmarket evidence generation

被引：8
|
作者：
Wallach, Joshua D. [1 ]
Ross, Joseph S. [2 ]
Naci, Huseyin [3 ]
机构：
[1] Yale Sch Med, Collaborat Res Integr & Transparency, New Haven, CT USA
[2] Yale Sch Med, Gen Internal Med Sect, Dept Internal Med, New Haven, CT USA
[3] London Sch Econ & Polit Sci, Dept Hlth Policy, LSE Hlth, 20 Houghton St, London WC2A 2AE, England
来源：
CLINICAL TRIALS | 2018年 / 15卷 / 03期
关键词：
The US Food and Drug Administration; pharmaceutical regulation; drug policy; expedited approval; postmarketing requirements; ACCELERATED APPROVAL; THERAPEUTIC AGENTS; FDA APPROVAL; POSTAPPROVAL; HEALTH;
D O I：
10.1177/1740774518770657
中图分类号：
R-3 [医学研究方法]; R3 [基础医学];
学科分类号：
1001 ;
摘要：
[No abstract available]
引用
收藏
页码：243 / 246
页数：4
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