FDAsafety guidance66% confidence
FDA Accepts First In Silico Drug Development Tool Under ISTAND Program to Help Predict Drug-Induced Liver Injury
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as Sanofi; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Cardiology · Antihypertensive
- Sub-indication
- Hypertension
Related signal: FDA Accepts Supplemental NDA for AVAPRO by Sanofi