ARTICLE
24 September 2015

FDA Publishes User Fee Rates For Using A Tropical Disease Priority Review Voucher In FY2016

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Jones Day

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In the September 14, 2015, Federal Register, FDA announced the fee rates for fiscal year 2016 associated with using a tropical disease priority review voucher ($2.7m).
United States Food, Drugs, Healthcare, Life Sciences

In the September 14, 2015, Federal Register, FDA announced the fee rates for fiscal year 2016 associated with using a tropical disease priority review voucher ($2.7m). The fee is determined each fiscal year based on an analysis of the prior year's data regarding the difference between the average cost incurred by FDA in the review of a human drug application subject to priority review and the average cost incurred in the review of an application not subject to priority review.

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