Priority Review Voucher Program Relies On Perceptions, BVGH Head Warns
This article was originally published in The Pink Sheet Daily
Coartem may not be perfect test case for advocates of incentive program.
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FDA guidance on incentive for neglected tropical disease research clarifies some key questions—but also stresses need for appropriation authority to make program work.
Malaria drug receives "priority" status from FDA, which should mean Novartis receives a voucher for priority designation on another product under new incentive program for tropical disease research. December application deadline also sets a deadline for FDA to defi ne key elements of how PRVs will work.