News Related to Rare Pediatric Disease

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Congress Extends Rare Pediatric Disease Priority Review Voucher Program to 2029

Apr 14, 2026

The Consolidated Appropriations Act, 2026 extends the FDA’s rare pediatric disease priority review voucher authority through Sept. 30, 2029. The law also requires a GAO report on the program’s effectiveness.

Congress Overrides Court Ruling, Limits Orphan Drug Exclusivity to Approved Indications

Mar 11, 2026

The Consolidated Appropriations Act, 2026 enacted February 3 narrows orphan drug exclusivity to specific approved uses rather than entire disease categories, overriding a 2021 court decision and codifying FDA's longstanding interpretation.