Issue Date: April 11, 2013
Issued by: Center for Drug Evaluation and Research
Topic(s): Over-the-Counter Drugs
Status: Final
Self-Selection Studies for Nonprescription Drug Products
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.
Download the Guidance Document
