FDAsafety guidance66% confidence
Investigational New Drug (IND) Application
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (immunology) as Roche; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Get to know the investigational new drug application (IND). This includes the types, laws and regulations, and emergency use of INDs.
Supporting Context
- Therapeutic area
- Neurology · Autoimmune Disorders
- Sub-indication
- Immunology
Related signal: FDA Accepts Supplement Application for ENSPRYNG (Satralizumab)