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National Priority Vouchers: What They Signal—and How Sponsors Can Get Ready
TL;DR: FDA’s new Commissioner’s National Priority Voucher (CNPV) program accelerates reviews to ~1–2 months for products that advance U.S. national priorities: big-burden diseases, public-health crises, affordability, and on-shored manufacturing. If you’re heading into this pathway, success hinges on early CMC and labeling completeness, disciplined traceability, and an operating model built for rapid, team-based review. What’s inside the program Why it exists: Speed acce

Jeanette Towles
2 days ago
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