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Archive: Introduction to the FDA

Course #: BI10337
October 25, 2010

Course Description

This course begins with a comprehensive overview of FDA’s entire organization, and then drills down into a review of the Drug, Biologic, and Medical Device Centers. We will look at how each center is organized, how each center functions, the types of submissions each center reviews, and how each center conducts the review process.

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Learning Objectives

  • Discuss general information about FDA
  • Detail the functions of the Center for Drug Evaluation and Research (CDER)
  • Detail the functions of the Center for Biologics Evaluation and Research (CBER)
  • Detail the functions of the Center for Devices and Radiological Health (CDRH)
  • Discuss the types of submissions each FDA center reviews

Who Should Attend

  • This course is appropriate for those who require a general introduction to FDA and how the FDA centers function, and professionals new to the industry that require an introduction to basic FDA information and are in Regulatory Affairs, Clinical, Quality, Manufacturing, Research, Legal, and other departments.


Albert A. Ghignone, M.S., R.A.C.

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