FDAsafety guidance83% confidence
IND Application Reporting: IND Safety Reports
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Novartis.
Regulatory Analysis
This webpage provides an overview of investigational new drug application (IND) safety reporting requirements for sponsors set forth in 21 CFR 312.32 and additional resources, including FDA guidances, related to these requirements.
Supporting Context
- Therapeutic area
- Hematology · JAK Inhibitor
- Sub-indication
- General
Related signal: Novartis initiates long-term safety study for ruxolitinib and panobinostat combination