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 (colorectal cancer) as National Cancer Institute.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Rectal Cancer
- Sub-indication
- Colorectal Cancer
Related signal: ROBIN Trial to Explore RT Effects on Immune System in Rectal Cancer