FDAsafety guidance84% confidence
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: illustrates how regulators handled a comparable safety guidance decision relevant to GSK; the same agency is already in play for this signal, so precedent weight is higher.
Regulatory Analysis
Discover potential signals of serious risks and new safety information identified by the FDA's Adverse Event Monitoring System (AEMS). Learn how the FDA monitors and evaluates drugs for safety concerns, providing important updates on adverse events to protect public health.
Supporting Context
- Therapeutic area
- Infectious Disease · Influenza
- Sub-indication
- General
Related signal: GSK's AS03-adjuvanted H5N8 vaccine shows promising immunogenicity and safety in Phase 1/2 trial
Source
FDA document
View source