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GUIDANCE FOR INDUSTRY: Label Comprehension Studies for Nonprescription Drug Products

Fri, Aug 6, 2010

Clinical News Room

can identify areas on the label that would benefit from clearer or simpler presentation of important consumer information.It is important to note that label comprehension study data do not predict consumer behavior (e.g., how consumers actually use a drug product). Drug product use and other behaviors are often evaluated in an actual use study. We recommend that the label used in an actual use study be tested in a label comprehension study beforehand to ensure that consumers understand the information on the label.

This guidance covers general principles related to the conduct of label comprehension studies and should not be considered a substitute for an FDA review of specific protocols. This guidance incorporates advice obtained from the September 25, 2006, meeting of the Nonprescription Drug Advisory Committee that considered issues related to analysis and interpretation of consumer studies conducted to support marketing of nonprescription drugs, and comments received regarding the draft guidance published on May 1, 2009.

To read the full Final Labeling Guidance Document please click on the following link: http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM143834.pdf

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