NJ MPJE questions with correct answers

Neither _____ nor _____ are required by an *ANDA*. - Answer -pre-clinical animal studies -clinical studies *bioequivalence only Prescription drug advertising is regulated by the _____, while OTC drug advertising is regulated by the _____. - Answer -FDA -FTC (Federal Trade Commission) Any false or misleading statements in a drug advertisement could be considered _____. - Answer -misbranding Pure Food and Drug Act (1906) description - Answer -mandated accurate product labeling and required that the ingredients used in drugs met the *standards of strength, quality, and purity in USP* -required that the food or drug label *could not be false or misleading*, and the presence and amount of eleven dangerous ingredients, including alcohol, heroin, and cocaine had to be listed -required that *no adulterated or misbranded drugs could be sent through interstate commerce*