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Generics Homepage

Generics Consumer Information

Orange Book

Online Training Seminar

"The FDA Process for Approving Generic Drugs"

June 2007

(No Credit Is Offered)

Optional True and False Quiz

1. The Hatch-Waxman Amendment to the FD&C Act provided a mechanism for the approval of generic drug products.

2. The Hatch-Waxman Amendments did not provide any benefits for innovator drug firms.

3. Approval of an abbreviated new drug application requires review of large clinical studies assessing the effectiveness of the product.

4. A generic drug may have a different route of administration than the reference drug.

5. Facilities manufacturing generic drug products are not inspected by FDA.

6. The “Orange Book” contains therapeutic equivalence evaluations.

7. Drug products that are rated “A” in the “Orange Book” may be substituted with full confidence.

8. The “Orange Book” lists expiration dates for patents and exclusivities.

9. To confirm bioequivalence, the rate and extent of absorption must not be statistically different when administered to humans at the same molar dose.

10. Solution drug products must be tested with in vivo bioequivalence studies.

11. Statistical analysis of bioequivalence studies looks at the confidence intervals of the test/reference ratio.

12. There is only one way to determine bioequivalence.

13. Generic NTI drug products require different bioequivalence limits than other drug products.

Answers to the quiz......