FDA opens door to feedback on ‘unclear’ national priority voucher pathway

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Source: Pharmaceutical Technology

Original: https://www.pharmaceutical-technology.com/news/fda-opens-door-to-feedback-on-unc...

Published: Thu, 26 Mar 2026 11:30:26 +0000

The FDA announces a public hearing to solicit feedback on the Commissioner's National Priority Voucher (CNPV) pilot program, which is considered unclear.[1][7] The hearing will be held on June 12, 2026 from 1:00 PM to 4:00 PM ET at FDA headquarters in Silver Spring, Maryland.[1] Registration for participation will open on April 1, 2026, and applications must be submitted by May 1, 2026.[1] Comments on the program can be submitted until June 29, 2026 through the regulations.gov system.[1] Launched in June 2025, the CNPV program accelerates drug approval by 1-2 months from the standard 6+ months using rolling review and tumor board-style meetings.[3][4][7] A total of 15 vouchers were issued for the program, including a second series of six for drugs such as zongertinib for lung cancer, bedaquiline for resistant tuberculosis in children, and casgeva for sickle cell anemia.[3][4] The FDA recently approved Hernexeos (zongertinib) for lung cancer 44 days after filing, where clinical data showed 76% of patients with significant tumor shrinkage versus 30-45% in standard care.[3] The program focuses on priorities in response to health crises, innovative therapies, large unmet needs, domestic production and availability of medicines.[7]