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 Aurobindo Pharma.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Diabetes · SGLT2 Inhibitor
- Sub-indication
- General
Related signal: Aurobindo Pharma submits ANDA for Empagliflozin