U.S. Food and Drug Administration
Protecting and Promoting Your Health
Small Business Assistance
Center for Drug Evaluation and Research
Bringing an Over-the-Counter (OTC) Drug to Market
Regulation Overview
Label Comprehension

Though OTC and prescription drugs may gain approval through the same NDA process, there is one striking difference. The FDA sometimes requires sponsors of OTC drugs to conduct consumer studies, including label comprehension, self-selection, and actual use studies that are designed to evaluate proposed OTC drug product labeling.

A label comprehension study assesses the extent to which consumers understand the information on OTC drug product labeling and how well they apply this information when making drug product-use decisions in a hypothetical situation.

If you are considering the submission of an NDA for an OTC drug product, you should review, among other things, FDA's guidance document on label comprehension and self-selection studies on FDA's Web site, accessible here.

A drug label with a text box: A label comprehension study can identify areas on the label that would benefit from a clearer or simpler presentation of important consumer information.
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