FDAsafety guidance83% 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 (ild) as Boehringer Ingelheim.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Pulmonology · Fibrosing Interstitial Lung Disease
- Sub-indication
- Ild
Related signal: Boehringer Ingelheim's Nerandomilast Trial for Fibrosing ILD Shows Potential for Disease Progression