FDAsafety guidance72% confidence
FDA Rare Disease Innovation Hub
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (cardiology) as CABG.
Regulatory Analysis
FDA created the Rare Disease Innovation Hub (the Hub) to serve as a point of collaboration and connectivity between CBER and CDER with the goal of ultimately improving outcomes for patients.
Supporting Context
- Therapeutic area
- Cardiology · Coronary Artery Disease
- Sub-indication
- Hypertension
Related signal: Study Compares PCI vs CABG in Diabetic Patients with Three-Vessel CAD