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 Teva.
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
- Not specified · Not specified
- Sub-indication
- General
Related signal: Teva initiates trial for TEV-56286 assessing pharmacokinetics and safety