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.
The FDA and the Pharmaceutical Drug Approval Process
by: Ravi Anupindi
Click on any button below to view the available document.
Make sure you are registered and/or logged in to our site to view product documents. Once registered & approved, faculty, staff, & course aggregators will have access to full inspection copies and teaching notes for any of our materials.
If you need to make copies, you MUST purchase the corresponding number of permissions, and you must own a single copy of the product.
Electronic Downloads are available immediately after purchase. "Quantity" reflects the number of copies you intend to use. Unauthorized distribution of these files is prohibited pursuant to term of use of this website.
This product does not have a teaching note.
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.