Expanding the Options: The Drug-Approval Process in the United States

The purpose of this course is to educate physicians and other healthcare professionals who prescribe drugs on how the FDA ensures the safety, efficacy, and security of approved products. In addition, members of the public may use this course to enhance their personal knowledge of the subject matter presented.


Upon completion of this course, you should be able to:


1. Explain the U.S. Food and Drug Administration's (FDA's) role in drug regulation.

2. Describe the origin of safety and efficacy standards.

3. Outline the steps of drug development and approval.

4. Differentiate the FDA's expedited new drug review pathways.

5. Describe the post-approval responsibilities of the FDA, manufacturers, and prescribers.

6. Explain expanded access, rare disease development, and orphan drug development.


This 5-hour continuing education course is available for download for professional development; if continuing education credit is desired, please see instructions included in eBook.