FDAsafety guidance83% confidence
S9 Nonclinical Evaluation for Anticancer Pharmaceuticals--Questions and Answers
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to older cancer patients.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Geriatric Assessment
- Sub-indication
- General
Related signal: University of Rochester Launches eGAP Study for Older Cancer Patients