A drug-for which pre-marketing approval is required by the Federal Food, Drug and Cosmetic Act. A new drug is any drug which is not generally recognized, among experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, as safe and effective for use under its prescribed conditions of use. Since 1962, most new prescription drugs have been subject to the new drug application and premarket over-the-counter, however, have not been through the new drug approval process.
A drug for which premarketing approval is required by the Food, Drug and Cosmetic Act. For the most part, new prescription drugs have been regulated by new drug application and premarket approval regulations, but most drugs sold over the counter (OTC) and directly to the public (i.e., nonprescription drugs) have not. There has been increased interest in evaluating the safety and efficacy of at least some OTC drugs.