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

A drug is not considered a new drug only when it is generally recognized as safe and effective (GRASE).

This is a very important concept to grasp, as much hinges on the GRASE determination.

In order to conclude a GRASE determination, a drug must satisfy three criteria:


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