Why (not) go East? Comparison of FDA Inspections from CEE, WE and US Investigational Site Inspections

Time

Tue, Mar 05 8:30AM
3

Title

Why (not) go East? Comparison of FDA Inspections from CEE, WE and US Investigational Site Inspections

Abstract Summary

From its publicly accessible Clinical Investigator Inspection List, an analysis was undertaken to compare the findings and outcome classifications for all routine FDA data audits (DA) of Investigational New Drug studies from 1994 through 2010 for the CEE region, Western Europe and the USA.

Poster Presenter

Paul H. Caldron
DO, MBA, FACP,
Clinical Associate Professor, Clinical Rheumatologist,
Arizona Arthritis and Rheumatology Associates, PC
United States

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