FDAsafety guidance72% confidence
January - March 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
Source: FDA
Why This Matters
Why this matters: sets a safety guidance precedent in the same sub-indication (nmus rehab) as Roche.
Regulatory Analysis
January - March 2024 | New Safety Information or Potential Signals of Serious Risks Identified from the FDA Adverse Event Monitoring System (AEMS)
Supporting Context
- Therapeutic area
- Oncology · Breast Cancer
- Sub-indication
- Nmus Rehab
Related signal: Study on Early Rehabilitation Protocol for Breast Cancer Surgery Shows Promising Safety and Feasibility