FDA Approval of Bedaquiline - The Benefit-Risk Balance for Drug-Resistant Tuberculosis

被引:150
作者
Cox, Edward [1 ]
Laessig, Katherine [1 ]
机构
[1] US FDA, Off Antimicrobial Prod, Off New Drugs, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
关键词
D O I
10.1056/NEJMp1314385
中图分类号
R5 [内科学];
学科分类号
100201 [内科学];
摘要
[No abstract available]
引用
收藏
页码:689 / 691
页数:3
相关论文
共 5 条
[1]
[Anonymous], SIRT BED PROD INS
[2]
[Anonymous], GLOB TUB REP 2013
[3]
Approval of a Tuberculosis Drug Based on a Paradoxical Surrogate Measure [J].
Avorn, Jerry .
JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2013, 309 (13) :1349-1350
[4]
Center for Drug Evaluation and Research, MED OFF REV SIRT BED
[5]
Natural History of Tuberculosis: Duration and Fatality of Untreated Pulmonary Tuberculosis in HIV Negative Patients: A Systematic Review [J].
Tiemersma, Edine W. ;
van der Werf, Marieke J. ;
Borgdorff, Martien W. ;
Williams, Brian G. ;
Nagelkerke, Nico J. D. .
PLOS ONE, 2011, 6 (04)