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Guidance on Tropical Disease Priority Review

10/20/2008

Federal Register Notice: FDA is making available a draft guidance, Tropical Disease Priority Review Vouchers. It explains to stakeholders how the agency will implement the provisions of Section 524 in the Federal Food, Drug, and Cosmetic Act that makes provisions for awarding priority review vouchers for future applications to sponsors of tropical disease product applications that meet the criteria specified by the act. To download this guidance, click here. To view this notice, click here.

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