FDAsafety guidance83% confidence
IND Application Reporting: IND Safety Reports
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (lung cancer) as Janssen.
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
- Oncology · NSCLC
- Sub-indication
- Lung Cancer
Related signal: Janssen's Amivantamab Study in Advanced NSCLC Evaluates Safety and Efficacy