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Orange Book

Online Training Seminar

"The FDA Process for Approving Generic Drugs"

June 2007

(No Credit Is Offered)

EDUCATIONAL PURPOSE:

This seminar provides viewers with an overview of the Food and Drug Administration's role in the generic drug process. It discusses various aspects of the Abbreviated New Drug Application (ANDA) process, including how FDA's approval assures that generic drugs are safe, effective, and high quality drug products.

LEARNING OBJECTIVES:

1. Cite legislation that enables the approval of generic drug products;
2. Describe the differences between the generic drug approval process and the innovator drug approval process;
3. Identify information contained in the "Orange Book";
4. Describe the methodology for determination of bioequivalence of drug products;
5. Describe the complexities of the patent certification process and the impact on the approval of generic drug products.

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