Neglected Tropical Disease Designation Rejected For First Time By US FDA
Pneumocystis pneumonia was determined to not meet criteria for a neglected tropical disease that could win sponsors of a new treatment a priority review voucher; FDA made four other diseases eligible.
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Only the first publicly disclosed sale of a priority review voucher was lower than what Jazz Pharmaceuticals paid Spark Therapeutics for its coupon.
FDA would gain ability to easily change list of diseases eligible for incentive, avoiding need for one-off legislation or rulemaking.
Government Accountability Office also finds that US FDA review divisions are largely consistent in their assessment times after controlling for goal dates and expedited programs.