FDA Data On Foreign Drugmakers Flawed: GAO

Law360, New York (October 22, 2008, 12:00 AM EDT) -- The U.S. Food and Drug Administration is keeping inaccurate records of the number of foreign establishments approved to send drugs to the United States and how many it inspects every year, and is failing to force those establishments to re-register once they expire, a Government Accountability Office study has found.

The FDA needs to improve the data it uses to keep track of the foreign establishments it reviews, carry out more inspections and make sure it visits those that appear to have serious deficiencies in a...
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