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为儿童开发药物的“创造希望”和其他激励措施。

"Creating hope" and other incentives for drug development for children.

机构信息

Office of Innovation Development and Investigational Therapeutics, Clinical and Translational Science Institute, Children's Research Institute, Children's National Medical Center, Washington, DC 20010, USA.

出版信息

Sci Transl Med. 2011 Jan 19;3(66):66cm1. doi: 10.1126/scitranslmed.3001707.

Abstract

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.

摘要

加强儿科疾病药物研发是当务之急,也是公共责任。2010 年《创造希望法案》是一项重要的新立法提案,它将治疗儿童罕见病的药物和生物制剂纳入有资格获得美国食品和药物管理局优先审查券的被忽视热带病药物之列。该法案通过为寻求治疗特定发生在儿童身上的孤儿病的新药儿科适应证的公司提供特定的经济利益,来增强现有激励计划。

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