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Regulatory Update

Posted 01 September 2010

In its efforts to improve over-the-counter (OTC) drug labels, the US Food and Drug Administration (FDA) announced the availability of new industry guidelines for designing, conducting and analyzing label comprehension studies. Often required before an OTC medication is approved-or following a change in formula or indications-these qualitative studies are conducted to assess the extent to which patients are able to understand and apply information from OTC drug labels. Products that fail to adequately communicate this information can cause patient errors that lead to serious adverse reactions.


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