The FDA and the Pharmaceutical Drug Approval Process

by: Ravi Anupindi

Publication Date: September 28, 2017
Length: 10 pages
Product ID#: 7-101-063

Core Disciplines: Operations Management/Supply Chain, Social Impact

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Teaching Note

This product does not have a teaching note.


This conceptual note provides an overview of the drug approval process in the United States. It examines the historical underpinnings and regulatory history that led to the creation of the United States Food and Drug Administration (FDA), the governing body over the consumer and commercial products which may affect human health. The note also discusses exceptions to the standard approval process and how that process can affect global health delivery.

Teaching Objectives

After reading and discussing the material, students should:

  • Understand the history and jurisdiction of the FDA.
  • Describe the stages and phases of the FDA's drug approval process.
  • Explain why the costs of developing a new drug are so high.
  • Recognize how the FDA approval process can affect global health delivery.