FDAsafety guidance66% confidence
Commissioner's National Priority Voucher (CNPV) Pilot Program
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
FDA Commissioner's National Priority Voucher Program. The Commissioner's National Priority Voucher Program offers an unprecedented opportunity to reduce drug and biologic review times from 10-12 months to just 1-2 months.
Supporting Context
- Therapeutic area
- Nephrology · Autoimmune Disease
- Sub-indication
- Immunology
Related signal: FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for primary membranous nephropathy