MHRAsafety guidance83% confidence
Clinical trials for medicines: collection, verification and reporting of safety events
Source: MHRA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (ild) as Eli Lilly.
Regulatory Analysis
Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
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