FDA Sets Consumer Test Policies As It Mulls Widening OTCs

Law360, New York (April 10, 2013, 5:16 PM EDT) -- The U.S. Food and Drug Administration on Tuesday finalized policies for studies that test consumer decision making as part of the approval process for over-the-counter medications, a development that comes as the agency considers making more medicines available without a prescription.

The agency issued a guidance document that applies to so-called self-selection studies, in which drugmakers examine whether most consumers will correctly determine whether a drug is a suitable treatment, using proposed labeling.

For instance, if a proposed OTC medication shouldn't be used by diabetics, the study would...
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