Tropical Disease
FDA Issues Draft Guidance on Priority Review Vouchers
Published in Medical Letter on the CDC and FDA, November 9th, 2008
BIO Ventures for Global Health (BVGH) announced its support of the US Food and Drug Administration's (FDA) release of Draft Guidance for Industry on Priority Review Vouchers. The Priority Review Voucher (PRV) program is designed to encourage industry investment in the development of drugs and vaccines for neglected tropical diseases. Enacted as part of the FDA Amendments Act, the program awards a Priority Review Voucher to any sponsor obtaining FDA approval for a product preventing or treating diseases such as malaria, tuberculosis and leishmaniasis. The voucher, which can be traded or sold, can be used to obtain priority review on a future product of the company's choosing, shaving months...
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