GRASE drug (Generally recognized as safe and effective)

GRASE DRUG (GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE)

 

GRASE is a term used to describe certain old drugs that do not require prior approval from FDA in order to be marketed because they are generally recognized as safe and effective based on published scientific literature.

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.