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U.S. Department of Health and Human Services

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OSI Metrics Overview

 

  • These slides provide annual inspection metrics for the compliance programs overseen by the Office of Scientific Investigations, or OSI (formerly the Division of Scientific Investigations, or DSI) in FDA’s Center for Drug Evaluation and Research (CDER). The vast majority of these inspections are conducted by FDA’s Office of Regulatory Affairs (ORA).
  • As FDA’s approval decisions are based on a review of the data submitted to the agency by an applicant, it is essential for the agency to ensure the integrity of the data submitted and to verify that the rights, health and welfare of those who participated in the studies were protected and that applicants continue to meet their obligations (e.g. for safety reporting) after approval.
     
  • On-site inspection is one of many tools the FDA has for ensuring the integrity of data, the health and welfare of research participants, and the protection of public health.
     
  • Data source:
    • Information was extracted from OSI’s databases and other sources as noted.
  • Data conventions
    • OSI metrics are based on key events during the inspection process, including starting an inspection, issuing an inspection assignment, or issuing post-inspectional correspondence to the inspected party.  
    • Differences in inspection counts when comparing data across varying sources (e.g. The Office of Regulatory Affairs’ (ORA) FACTS database) may be the result of different tallying methods of inspection-related data.
  • Changes from prior versions
    • Footnotes in individual slides indicate where significant changes from previous versions have occurred. These changes are due to improvements to OSI’s database and associated processes.
    • The current slides are the January 2014 release containing information from FY2013.

    OSI Metrics - January 2014 (PDF - 1.6MB)

     

  • For further information, please contact cder-osi@fda.hhs.gov or 301-796-3150.

    Return to the OSI Homepage