FDAsafety guidance66% confidence
FDA-TRACK: Prescription Drug User Fee Act Review Goals Summary
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
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