January 14, 2007
Questionable MDS Tests and Drug Approval Applications to FDA
Article in the Wall Street Journal -- MDS Tests Are at Center Of FDA Query, by Jennifer Corbett Dooren:
The Food and Drug Administration is asking all drug companies that have submitted drug-approval applications to the agency since 2000 to review them to see if they include questionable test results conducted by a unit of MDS Inc.
The FDA's action affects about 1,100 approved and pending drug applications for both brand-name and generic drugs. Agency officials said yesterday they aren't aware of any drug-safety problems but are taking the action as a "precautionary measure."
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