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Open Access Publications from the University of California

UC Comments on FDA Final Order regarding Designating Additions to the Current List of Tropical Diseases in the Federal Food, Drug, and Cosmetic Acton [FDA-2008-N-0567-0055]

Abstract

This comment letter responds to the FDA’s Final Order expanding the list of tropical diseases eligible for the Tropical Disease Priority Review Voucher (PRV) Program. UC supports the announced additions but urges FDA to also include coccidioidomycosis (Valley Fever), arguing that it meets the program’s eligibility criteria and that PRV incentives could encourage development of urgently needed diagnostics, treatments, vaccines, and cures.