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Priority review voucher : ウィキペディア英語版 | Priority review voucher The priority review voucher in the United States is an expedited review granted by the Food and Drug Administration (FDA) to the developer of a treatment for neglected diseases. The system was first proposed by Duke University faculty David Ridley, Henry Grabowski, and Jeffrey Moe in their 2006 ''Health Affairs'' paper: "Developing Drugs for Developing Countries." In 2007 Senators Sam Brownback (R-KS) and Sherrod Brown (D-OH) sponsored an amendment to the FDA Amendments Act of 2007. President George W. Bush signed the bill in September 2007. ==Summary==
The priority review is an incentive for companies to invest in new drugs and vaccines for neglected tropical diseases. A provision of the Food and Drug Administration Amendments Act (HR 3580) awards a transferable “priority review voucher” to any company that obtains approval for a treatment for a neglected tropical disease. Sponsored by Senators Sam Brownback (R-KS), and Sherrod Brown (D-OH), this provision adds to the market-based incentives available for the development of new medicines for developing world diseases such as malaria, tuberculosis and African sleeping sickness.
抄文引用元・出典: フリー百科事典『 ウィキペディア(Wikipedia)』 ■ウィキペディアで「Priority review voucher」の詳細全文を読む
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