Breakthrough Therapy / Priority Review / Priority Voucher
Breakthrough Therapy, Priority Review and the Priority Voucher are FDA fast lanes for drugs that look substantially better than existing options.
Breakthrough Therapy (2012) gives intensive guidance; Priority Review shortens review to 6 months; the 2025 Commissioner's National Priority Voucher pilot promises 1-2 month reviews for selected products (sac-TMT received one in July 2026).
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not linked directly; found by shared links- TermLabel, indication and label expansion
Shares Orphan drug designation, BLA / NDA / MAA (marketing applications) and PDUFA dates.
- IdeaA Health Impact Fund pilot that pays for measured health gain instead of price
Shares Transferable priority vouchers for first-in-class drugs, with price conditions, Incentives reward me-too drugs and marginal gains.
- IdeaUniversity licences with royalties indexed to benefit and global access
Shares Transferable priority vouchers for first-in-class drugs, with price conditions, Incentives reward me-too drugs and marginal gains.
- TermAccelerated approval
Shares Real-Time Oncology Review (RTOR) and Assessment Aid, Fast Track and RMAT designations, Orphan drug, Transferable priority vouchers for first-in-class drugs, with price conditions.
- TermRare cancers
Shares Orphan drug designation, Orphan drug.
- InstitutionComisión Federal para la Protección contra Riesgos Sanitarios
Shares FDA Oncology Center of Excellence, Regulatory divergence between regions.
- IdeaPatent term extension scaled to proven survival gain
Shares Transferable priority vouchers for first-in-class drugs, with price conditions, Incentives reward me-too drugs and marginal gains.
- IdeaSponsors deposit the confirmatory trial budget in escrow at accelerated approval
Shares Regulatory divergence between regions, Incentives reward me-too drugs and marginal gains.