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FDA OTC office working with ad division on label-comprehension study protocols.

This article was originally published in The Tan Sheet

Executive Summary

FDA's OTC OFFICE DEVELOPING LABEL COMPREHENSION PROTOCOLS in conjunction with the agency's division of drug advertising "for some of the switches that are coming down the pike," Medical Review Staff Director Deborah Bowen, MD, told a June 28 session of the Drug Information Association's annual meeting in Orlando. "Even if all other [Rx-to-OTC switch] criteria have been met for a particular drug product, it has to have a label which adequately informs and warns consumers about safe and effective use," Bowen commented.
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