Clinical studies involving probiotics When FDA's investigational new drug rubric applies-and when it may not

被引:20
作者
Degnan, Fred H. [1 ]
机构
[1] King & Spalding LLP, Washington, DC 20006 USA
关键词
probiotics; investigational new drug (IND); institutional review board (IRB); FDA; drug definition; medical food; protocol;
D O I
10.4161/gmic.22158
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
引用
收藏
页码:485 / 489
页数:5
相关论文
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[Anonymous], 2001, HLTH NUTR PROP PROB
[2]  
[Anonymous], 1993, FED REG, V2478, P2505
[3]  
Collado MC, 2009, HDB PROBIOTICS PREBI
[4]  
Draft Guidance for Industry, 2006, DRAFT GUIDANCE IND C
[5]  
US Department of Health and Human Services US Food and Drug Administration, 2000, FED REGISTER, V65, P1000