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 Boehringer Ingelheim.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Oncology · Combination Therapy
- Sub-indication
- General
Related signal: Boehringer Ingelheim Initiates Dose-Exploration Study of BI 1831169 with Anti-PD1 in Advanced Cancer