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In Brief: FDA OTC label study

This article was originally published in The Tan Sheet

Executive Summary

FDA OTC label study: Data summarizing results of the agency's "Over-the-Counter Label Format Preference" study, also known as Study B, are expected to be published in the Federal Register the week of Dec. 22. Planned for 900 participants, the mall-intercept study examined perceptions of different label designs for cough/cold and sunscreen products. Participants were asked to "evaluate labeling terminology and graphics to investigate how they interpret various ways of communicating drug safety and effectiveness," FDA says in a notice summary. Comments on the data will be accepted for 45 days from the date of publication. FDA announced its intention to conduct Study B and a related 1,200-subject study in its Feb. 27 proposed rule on OTC label reform; the agency described plans for the studies in May ("The Tan Sheet" May 26, p. 1)...

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