title: The FDA's failure to address the lack of generalisability of antidepressant efficacy trials in product labelling.
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.
authors.affiliation: Mark Zimmerman, MD, Department of Psychiatry and Human Behavior, Brown University School of Medicine, Rhode Island Hospital, Providence, RI 0294, USA. Email: mzimmerman@lifespan.org.
authors.forename: Mark
authors.initials: M
authors.lastname: Zimmerman
mesh_terms: D000928:Antidepressive Agents / Q000494:pharmacology*; D002986:Clinical Trials as Topic / Q000592:standards*; D017408:Guidelines as Topic / Q000592:standards*; D006801:Humans; D011356:Product Labeling / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards*
chemical_list: D000928:Antidepressive Agents