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FDA Issues Self-Selection Study Guidance

 The U.S. Food and Drug Administration (FDA) has finalized a guidance for self-selection studies. The development program for certain consumer health products may include conducting certain studies, including self-selection studies. A self-selection study assesses the ability of consumers to apply health product labelling information to their personal health situation to make correct decisions about whether or not it is appropriate for them to use the product. The FDA guidance has recommended firms ask more complex questions for products being switched from prescription to consumer health product status to allow the evaluation of multiple endpoints, something that could be useful for switches. As an example, complex questions could be used to evaluate self-selection of a product that is only for women between 18 and 65 years of age who do not have heart disease or hypertension. A correct self-selection would be a woman who meets both criteria, and an incorrect self-selection would be woman who meets only one element. The guidance also recommends that, when necessary, the study be enriched with subjects who have relative or absolute contraindications to use of the drug product. This would serve to double-check the conditions of safe use. It is expected that Health Canada will consider this guidance when developing a switch guidance document.