FDAsafety guidance83% confidence
S6 (R1) Addendum: Preclinical Safety Evaluation of Biotechnology - Derived Pharmaceuticals
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to Cadila Pharmaceuticals.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Psychiatry · Antidepressant
- Sub-indication
- General
Related signal: Cadila Pharmaceuticals Issues Class 4 Defect Notification for Mirtazapine 30mg Tablets