FDAsafety guidance66% confidence
FDA Rare Disease Innovation Hub
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (rare disease) as Casper Pharma; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
Supporting Context
- Therapeutic area
- Rare Diseases · Cystinosis
- Sub-indication
- Rare Disease
Related signal: FDA Accepts NDA for Tiocystin by Casper Pharma