Two decades of orphan product development

被引:101
作者
Haffner, ME [1 ]
Whitley, J [1 ]
Moses, M [1 ]
机构
[1] US FDA, Off Orphan Prod Dev, Rockville, MD 20857 USA
关键词
D O I
10.1038/nrd919
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
Over the past 20 years, incentives of the Orphan Drug Act (ODA), the largest single source of extramural clinical grants at the US Food and Drug Administration, have had a substantial impact on public health. ODA incentives have contributed to the development of many innovative biotechnology products, and as our understanding of the human genome evolves, it is anticipated that pharmacogenomics will result in the identification of more 'orphan diseases'.
引用
收藏
页码:821 / 825
页数:5
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