FDAsafety guidance66% confidence
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for TEVA PHARMACEUTICALS, INC; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Not specified
- Sub-indication
- General
Related signal: TEVA Pharmaceuticals submits ANDA219413 for FDA review