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If a Generic Version of a Drug Is Approved for Marketing

Question 4

Multiple Choice

If a generic version of a drug is approved for marketing on the basis of a study comparing the oral bioavailability of the generic and brand name product, which term is associated with the review of this product by the Food and Drug Administration?


A) Harris-Kefauver amendment
B) accelerated drug approval
C) orphan drug amendment
D) abbreviated new drug application
E) investigational new drug

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