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GUIDANCE DOCUMENT

Label Comprehension Studies for Nonprescription Drug Products August 2010

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2009-D-0181
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

The Food and Drug Administration (FDA) sometimes requires sponsors to conduct label comprehension studies that are designed to evaluate proposed nonprescription drug product labeling. This guidance is intended to provide recommendations to industry on conducting label comprehension studies.  A label comprehension study assesses the extent to which consumers
 

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All written comments should be identified with this document's docket number: FDA-2009-D-0181.

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