FDAsafety guidance72% confidence
Demonstrating Substantial Evidence of Effectiveness for Human Drug and Biological Products
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (pain) as pediatric anesthesia practices.
Regulatory Analysis
Supporting Context
- Therapeutic area
- Anesthesiology · Pediatric Pain Management
- Sub-indication
- Pain
Related signal: Study on Perfusion Index vs Surgical Pleth Index for Pediatric Caudal Block Effectiveness