The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling

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Abstract

According to the US Food and Drug Administration's (FDA's) regulations, the criteria used to select patients into registration studies should be addressed in a product's label. The FDA's labelling guidelines, which specifically indicate that the routine exclusion of patients of a certain level of severity should be noted in the label, has been uniformly ignored.

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