Substantial Changes On "Substantial Evid&nce" Citations By FDA
FDA's ad division appears to be shifting the focus of its promotional oversight to emphasize problematic comparative claims as opposed to safety concerns, according to an analysis by "The Pink Sheet." All but one of the letters sent in 2006 cited shortcomings in safety presentations (the exception was a letter to Boehringer Ingelheimabout formulary placement claims for Spiriva Handihaler). In contrast, about 71 percent of the letters this year cite safety issues. Although FDA is on track to send approximately the same total number of letters as it did last year, the agency is using "untitled" letters more frequently then it did last year.
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