Rare Pediatric Disease Voucher Program Gains Temporary Extension From House Committee
US incentive program would gain only four more years, despite calls for a permanent extension.
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Immuno-oncology will remain a major force at both FDA’s drugs and biologics centers, but watch for psychiatry and antibiotics to make some noise; rare pediatric diseases will remain prominent as the priority review voucher program heads into the sunset.
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.
OOPD’s deputy director has been named the acting head of the office responsible for orphan and rare pediatric disease designations.