U.S. Food and Drug Administration
Protecting and Promoting Your Health
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:
- First, the particular drug product must have been subjected to adequate and well-controlled clinical investigations that establish the product as safe and effective.
- Second, those investigations must have been published in the scientific literature available to qualified experts.
- Third, experts must generally agree, based on those published studies, that the product is safe and effective for its intended uses. At a minimum, the general acceptance of a product as GRASE must be supported by the same quality and quantity of scientific and/or clinical data necessary to support the approval of a New Drug Application.
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