FDAsafety guidance72% confidence
Guidance Documents for Rare Disease Drug Development
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (rare disease) as Ipsen.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Hepatology · Rare Disease
- Sub-indication
- Rare Disease
Related signal: Ipsen initiates trial for elafibranor in Primary Sclerosing Cholangitis