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About: New Animal Drug Application     Goto   Sponge   NotDistinct   Permalink

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A New Animal Drug Application is an American legal terminology, defined in 21 CFR ¶514, after the definition in ¶510 of the term New Animal Drug. It is utilized by the FDA. A new animal drug is defined, in part, as any drug intended for use in animals other than man, including any drug intended for use in animal feed but not including the animal feed, the composition of which is such that the drug is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggested in the labeling of the drug. It was mandated by the Federal Food, Drug, and Cosmetic Act, as modified by Food and Drug Administration Amendments Act of 2007 on 27 September 2007, and is the analogue of the New Drug Application for humans.