FDAsafety guidance72% confidence
Pediatric Tracking Requirements Under FDAAA
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Eli Lilly.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Rheumatology · Systemic Juvenile Idiopathic Arthritis
- Sub-indication
- Ild
Related signal: Eli Lilly's Baricitinib Evaluated for Safety in Pediatric sJIA Patients