When Is An Adverse Event Not An Adverse Reaction?
Misclassifying adverse events and adverse reactions is a major source of error on drug labels, Leander Fontaine, former head of labeling at Wyeth, said.
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Less than a year after signing a consent decree to resolve compliance problems, the company is forced to stop manufacturing its generic version of the best-selling cholesterol drug. For FDA, the issue poses a public relations challenge since it touches on several areas where the agency has recently been criticized – generic drug quality, manufacturing oversight and drug shortages.