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

  • First, the particular drug 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.