Saturday, March 04, 2006

FDA says post market tests on drugs not done

FDA says 65% of testing that is mandated for drug companies to perform on safety are not completed - from the Canadian Press

"This new information is an embarrassing continuation of similar reports issued by FDA each year on the appalling state of the medication safety studies it has 'mandated' drug manufacturers to perform. It is scandalous that of the supposedly active studies, about two-thirds haven't even been started yet," Avorn said.

The FDA said it relies on the so-called Phase 4 studies to gather additional information about a drug's safety, efficacy or use. The FDA also can require the studies after it has approved a drug, including to better determine its safe use in children."

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