FDA's Expedited Approval Mechanisms for New Drug Products

被引:53
作者
Kepplinger, Erin E. [1 ]
机构
[1] Harvard Univ, Sch Publ Hlth, Boston, MA 02115 USA
关键词
INNOVATION; SAFETY;
D O I
10.1089/blr.2015.9999
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
[No abstract available]
引用
收藏
页码:15 / 37
页数:23
相关论文
共 85 条
[1]   A survey of breakthrough therapy designations [J].
Aggarwal, Saurabh .
NATURE BIOTECHNOLOGY, 2014, 32 (04) :323-330
[2]  
Aldes Jamie L, 2008, Health Matrix Clevel, V18, P463
[3]  
American Cancer Society, MEL SKIN CANC WHAT A
[4]  
[Anonymous], ZYDELIG
[5]  
[Anonymous], 2014, ZYKADIA
[6]  
[Anonymous], 2014, Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics
[7]  
[Anonymous], 2014, ARZERRA
[8]  
[Anonymous], PAV WAY PERS MED FDA
[9]  
[Anonymous], 2014, IMBRUVICA
[10]  
[Anonymous], 2014, HARVONI