In Brief: FDA OTC label study
This article was originally published in The Tan Sheet
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)...
You may also be interested in...
Perrigo promotes in pricing, planning
Combe sells most of its OTC brands
Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC