According to the U.S. Food and Drug Administration, a "new chemical entity means a drug that contains no active moiety that has been approved by FDA in any other application submitted under section 505(b) of the Food, Drug and Cosmetic Act." The United States Food and Drug Administration (FDA) is the government agency responsible for regulating food (human and animal), dietary supplements, drugs (human and animal), cosmetics, medical devices (human and animal), biologics and blood products in the United States. ...