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Label comprehension guidance on list again

This article was originally published in The Tan Sheet

Executive Summary

The Center for Drug Evaluation and Research continues developing its guidance on label comprehension studies for nonprescription drugs. The center Feb. 5 publishes its 2009 1agenda of guidances, a list that includes a total of 42 items in 14 CDER categories. Specifically, the list includes guidances on labeling dietary supplements for women who are or could be pregnant, dosage delivery devices for liquid OTCs and drug names and dosage forms. Publication of the guidance on label comprehension studies is anticipated by drug firms because questions on the design of such studies surfaced during FDA advisory committees' reviews of Rx-to-OTC switch applications (2"The Tan Sheet" Sept. 22, 2008, p. 6). CDER long has recommended improving OTC labeling and label comprehension studies to account for the growing complexity of nonprescription drugs and their indications (3"The Tan Sheet" Dec. 4, 2006, p. 9)

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