FDA regulations state print ads for prescription drugs must provide a true statement of information “in brief summary” describing “side effects, contraindications and effectiveness.” To fulfill these requirements, these ads… Click to show full abstract
FDA regulations state print ads for prescription drugs must provide a true statement of information “in brief summary” describing “side effects, contraindications and effectiveness.” To fulfill these requirements, these ads typically display risk information both as important safety information (ISI) on the “main” ad page with the product claims and on a separate “brief summary” page. The ISI can be lengthy and may repeat brief summary content.
               
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