Over the past few years, FDA has been blamed for scandals at overseas manufacturing and been pressured to improve foreign inspections. While he agency is looking for a global solution, it also has responded by increasing international inspections.
Pharmalot recent report on the latest OSI Bioresearch Monitoring Metrics Overview [PDF link] highlights this:
...when we eliminate the US from the data, Eastern Europe and Latin America are getting more attention which, of course, reflects the growing number of clinical trials taking place in those regions. Of 116 foreign investigator inspections, 34 percent in fiscal year 2010 were conducted in Asia, compared with 34 percent in 2003. The number of inspections of Eastern European investigators grew to 9 percent, from nothing in 2003. Latin American went to 14 percent from 9 percent.While the number of sites inspected may still be small, FDA is clearly shifting its attention overseas.
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