US FDA has shelved the Commissioner's National Priority Voucher program, sources told Reuters, removing a fast-track drug review initiative aimed at cutting review timelines to roughly one to two months for therapies addressing urgent national priorities. The program had launched in June 2025 during the Trump administration. Critics cited concerns about preferential treatment tied to political or pricing considerations. The decision affects companies that had designed submission strategies around the accelerated voucher-driven timeline. The shelving also signals a shift in how regulatory acceleration is being operationalized, with downstream implications for late-stage planning and launch schedules across therapy areas.
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