FDAsafety guidance77% confidence
Form FDA 3674 - Certifications To Accompany Drug, Biological Product, and Device Applications/Submissions
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