FDAsafety guidance83% confidence
FDA AP — DATSCAN (SUPPL)
Source: FDA
Why This Matters
Why this matters: illustrates how regulators handled a comparable safety guidance decision relevant to ICU departments.
Regulatory Analysis
Application NDA022454. Sponsor: GE HLTHCARE INC. Submission status: AP. Submission type: SUPPL. Review priority: STANDARD. Active ingredients: IOFLUPANE I-123.
Supporting Context
- Therapeutic area
- Critical Care · Catheterization
- Sub-indication
- General
Related signal: Study on Ultrasound Guidance for Central Catheterization in Obese ICU Patients