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.”

BGS