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  1. Center for Drug Evaluation and Research | CDER

Office of Quality Surveillance

Who We Are

The Office of Quality Surveillance (OQS) continuously monitors and provides the state of quality for all regulated sites and products.

What We Do

  • Assures that quality medicines are available through signal detection, data analysis, review of the state of quality, and proactive stakeholder engagement.
  • Coordinates analytics, informatics and research efforts to enable for programmatic enhancements, efficiencies, and data integration toward a comprehensive surveillance program that can support other Office of Pharmaceutical Quality (OPQ) data intelligence needs.
  • Directs an analytic and potentially predictive program to assess and report on the state of quality of regulated industry at site and product levels using informative, innovative, and impactful data sources.
  • Develops innovative approaches to surveillance paradigms that complement established inspection programs, enhancing both surveillance coverage, international collaboration, and industry engagement.
  • Manages quality-related signals and risks from drug sites and products to inform future surveillance activities, resource allocation, shortages, enforcement decisions, application assessments, and communications with external stakeholders (e.g., Congress, industry, and the public).
  • Supports Food and Drug Administration’s (FDA) work toward international regulatory harmonization including regulatory FDA capability assessments and quality areas to be addressed during surveillance inspections.
  • Collaborates with FDA business partners to recommend and develop regulations, guidance, and policy that improve regulatory reporting, mitigate risks, and address recurring or acute manufacturing quality issues.
  • Collaborates in drug program training development, including creating and delivering materials and standards for staff who conduct quality surveillance inspection.

Office Organization

These organizations report to the Office of Quality Surveillance:

  • Division of Quality Data Science
  • Division of Quality Intelligence I
  • Division of Quality Intelligence II

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