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 (copd) as Teva; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Respiratory · Asthma/COPD
- Sub-indication
- COPD
Related signal: FDA Accepts Application for Budesonide and Formoterol Fumarate Dihydrate