FDA launches real-time reporting of adverse event data

On 22 August 2025, the U.S. Food and Drug Administration (FDA) announced the launch of daily public updates of adverse event reports in the FAERS (FDA Adverse Event Reporting System). This transition from delayed batch reporting to near real-time access represents a major step toward greater transparency and continuous pharmacovigilance.

What this means for stakeholders

• Patients: immediate visibility of new adverse events linked to marketed products.
• Healthcare professionals: timely signals enabling rapid adjustments to treatment regimens.
• Manufacturers: stronger obligations to monitor, triage, and act on safety signals faster than before.

Regulatory context

FAERS mainly concerns drugs and biologics, but the implications reach into MedTech. The EU MDR and IVDR already require Post-Market Surveillance (PMS) and Periodic Safety Update Reports (PSUR). FDA’s move reinforces the global trend toward accelerated signal detection and proactive market safety actions.

Practical implications for device manufacturers

1. Faster analysis cycles: safety dashboards should move from monthly to weekly review.
2. Integrated data sources: combine internal complaint-handling systems with external regulator feeds.
3. Transparent communication: NB and competent authorities should be informed immediately if benefit–risk ratios change.

Summary

FDA’s initiative sets a global precedent. Manufacturers who build agile safety systems that rapidly transform incoming signals into decisions and CAPAs will stay ahead of regulatory expectations while reducing the risk of supply disruptions or recalls.