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FDA launches priority vouchers for neglected-disease drugs

Nature Biotechnology volume 26, pages 1315–1316 (2008)Cite this article

The new scheme awards a priority review voucher to any company obtaining FDA approval for a product that prevents or treats a neglected disease, most of which are also tropical diseases. The program, launched in October, was enacted as part of the FDA Amendments Act (Nat. Biotechnol. 25, 1061, 2007). Vouchers can be used to accelerate approval of any drug in any disease indication that would not normally qualify for priority review by placing them on the FDA's Priority Review list (Box 1).

Obtaining a spot on this list can cut in half the time it takes for the agency to act on a new drug application (NDA). That can translate into hundreds of millions of dollars for a company with a potential blockbuster drug, and more for a company competing to be first on the market with a new class of therapeutics, says Henry Grabowski, an economist at Duke University in Durham, North Carolina. Grabowski was part of the team that originally proposed the priority-reviews vouchers idea (Health Affairs, 25, 313–324, 2006).

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    Emily Waltz

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Waltz, E. FDA launches priority vouchers for neglected-disease drugs. Nat Biotechnol 26, 1315–1316 (2008). https://doi.org/10.1038/nbt1208-1315

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