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FDA's Scrutiny of Drug Makers Abroad Faulted (Asia)

This article was originally published in PharmAsia News

Executive Summary

A preliminary report by the Government Accountability Office shows the U.S. Food and Drug Administration would inspect overseas drug manufacturers once every 13 years at its typical pace. In fact, the USFDA only has records of ever inspecting a third of the 3,249 foreign drug companies on its priority list. In 2007, the agency inspected 13 out of the 714 Chinese drug makers that may export to the U.S. Out of 410 Indian facilities that could be inspected, only 65 were observed this year. In light of these findings, U.S. pharmaceutical companies say overseas drug manufacturers should be held to domestic standards. By law, U.S. manufacturers must be inspected every two years. (Click here for more - May Require Paid Subscription

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