FDA publishes OSI Statistics

OSI (Office of Scientific Investigations) publishes an overview of metrics on their homepage

The slides provided as PDF download file show the annual inspection metrics for compliance overseen by the OSI, OSIS, CDER.

The data stem directly from CDER’s database “Complis” and other sources as noted in the PDF.

The slides show a very interesting increase in inspections focusing on Bioequivalence studies.

Also notable is that the majority of the findings at investigational sites results from protocol non-compliances.

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