FDAsafety guidance72% confidence
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (nmus rehab) as Roche.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Breast Cancer
- Sub-indication
- Nmus Rehab
Related signal: Study on Early Rehabilitation Protocol for Breast Cancer Surgery Shows Promising Safety and Feasibility