"Creating Hope" and Other Incentives for Drug Development for Children
"Creating Hope" and Other Incentives for Drug Development for Children
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DOI：
10.1126/scitranslmed.3001707
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发表时间：
2011-01-19
影响因子：
17.1
通讯作者：
Cure, Pablo
中科院分区：
文献类型：
--
作者：
Connor, Edward;Cure, Pablo
加强儿科疾病药物开发是一项优先事项，也是一项公共责任。2010年的《创造希望法案》是一项重要的新拟议立法，将治疗儿童罕见疾病的药物和生物制品添加到被忽视的热带疾病的药物和生物制品中，符合美国食品和药物管理局(FDA)优先审查凭证的资格。该法案通过向寻求儿科适应症的公司提供具体的财务利益，加强了现有的激励计划，这些公司寻求一种新药来治疗一种专门发生在儿童中的孤儿疾病。
Enhancing drug development for pediatric disease is a priority and a public responsibility. The Creating Hope Act of 2010 is important new proposed legislation that adds drugs and biologics for treating rare diseases in children to those for neglected tropical diseases as eligible for a priority review voucher from the U.S. Food and Drug Administration. The Act enhances existing incentive programs through specific financial benefits to companies who seek a pediatric indication for a new drug to treat an orphan disease that occurs specifically in children.