generally recognized as effective
Also found in: Acronyms.
generally recognized as effective (GRAE)
one of the statutory criteria that must be met by a drug before it can be approved as a new drug. Meeting these criteria relieves the manufacturer of the necessity of obtaining premarket approval as required by the Federal Food, Drug, and Cosmetic Act. To be recognized as effective, the drug must be, according to the act, considered safe and effective by "experts qualified by scientific training and experience."