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Rare Pediatric Disease Voucher Program Gains Temporary Extension From House Committee

Executive Summary

US incentive program would gain only four more years, despite calls for a permanent extension.

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As More Products Get Priority Review, User Fee Cost Gap From Standard Review Is Narrowing

US FDA’s priority review voucher fee will decrease again in FY 2022 as the cost of a priority assessment continues to trend closer to the cost of a standard assessment.

US FDA Seeking New Orphan Products Office Director Amid Internal Moves

OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.

Priority Review Voucher Fee Decreases For FY 2021 May Reflect US FDA Personnel Changes

In part because assessment costs plummeted in FY 2019, the FY 2021 fee to redeem a priority review voucher will be 37% less than the previous year.

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