FDA
FDA awards first national priority vouchers to nine drug sponsors
FDA launched the Commissioner’s National Priority Voucher (CNPV) pilot program, granting nine sponsors expedited review for products with significant potential to address critical national priorities. These priorities include large unmet medical needs, reducing downstream health care utilization, responding to public health crises, boosting domestic manufacturing, and improving medication affordability through "Most Favored Nation" pricing. Under the program, sponsors will receive a decision within 1 to 2 months after filing a complete application, along with enhanced communication throughout development and review. In a recent news release, FDA stated it retains the right to extend timelines for incomplete applications or manufacturing violations.
The CNPV process shortens the standard 10 to 12 month review by using a multidisciplinary team-based approach, concurrent application review, and a final one-day “tumor board style” meeting. Each FDA drug review division nominated one product, and sponsors could also apply for consideration. Selected products include:
- Pergoveris for infertility
- Teplizumab for type 1 diabetes
- Cytisinicline for nicotine vaping addiction
- DB-OTO for deafness
- Cenegermin-bkbj for blindness
- RMC-6236 for pancreatic cancer
- Bitopertin for porphyria
- Ketamine for domestic manufacturing of a critical anesthetic
- Augmentin XR for domestic manufacturing of a common antibiotic
The agency anticipates announcing additional voucher recipients in the coming months.
Source:
(2025, October 16). FDA. FDA Awards First-Ever National Priority Vouchers to Nine Sponsors [News Release]. https://www.fda.gov/news-events/press-announcements/fda-awards-first-ever-national-priority-vouchers-nine-sponsors