Completed ARIA Assessments & Impact

How the FDA Uses Active Risk Identification and Analysis (ARIA)

ARIA can contribute to FDA’s regulatory process in a variety of ways. This includes:

  • Providing reassuring data to address new concerns about the safety of a medical product
  • Contributing evidence to support a label change
  • Responding to a citizen's petition
  • Becoming part of an Advisory Committee deliberation
  • Providing evidence that alleviates concerns about a particular safety issue

Each ARIA analysis listed below contributed to an important regulatory discussion or action. FDA makes decisions about drug safety issues based upon the totality of evidence.

 

*This query was performed using Mini-Sentinel’s Modular Program 3, the precursor to an ARIA L1 analysis.

**Complete results are contained in the associated publications and/or final written reports. 

 

Completed ARIA Assessments & Impact

Completed Mini-Sentinel Analyses & Impact

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