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  1. Center for Drug Evaluation and Research | CDER

OSI Metrics Overview

  • This presentation: OSI_OSIS Metrics FY2023 (PDF - 1MB) provides annual inspection metrics for fiscal year 2023 for the compliance programs overseen by the Office of Scientific Investigations, or OSI and the Office of Study Integrity and Surveillance, or OSIS, 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.
  • Onsite 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 CDER's database Complis and other sources as noted.
  • Data conventions
    • These 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 may be the result of different tallying methods of inspection-related data.
  • For further information, please contact (301) 796-3150.
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