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GUIDANCE DOCUMENT

Self-Selection Studies for Nonprescription Drug Products April 2013

Download the Final Guidance Document Read the Federal Register Notice
Final
Docket Number:
FDA-2011-D-0620
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research

This guidance is intended to provide recommendations to industry involved in developing and conducting self-selection studies to support an application for nonprescription drug products. A self-selection study assesses the ability of consumers to apply drug labeling information to their personal health situation to make correct decisions about whether or not it is appropriate for them to use a drug product.
 

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All written comments should be identified with this document's docket number: FDA-2011-D-0620.

 
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