Regulation of Generic Drugs in the US
This course provides a basic understanding of the legal and regulatory structure of generic drugs in the US. It covers myriad topics, including the concepts of bioequivalence and therapeutic equivalence, the role and mechanics of patents and nonpatent marketing exclusivity, application components, postapproval maintenance of approval, and the new generic drug user fee requirements.
At a Glance
- Target Audience: This course is designed for regulatory professionals and others in related departments interested in understanding the basics of generic drug regulation and approval in the US.
- Learning Level: Basic
- Total Length of Course: 3 Hours
- RAC Points: 3
- Pharmaceutical Certificate Elective
- Enrollment Period: 12 months
Learning Objectives
Upon completion of this course, participants should be able to:- Describe the path to approval of an Abbreviated New Drug Application (ANDA)
- Identify possible obstacles that might impede approval and explain the solutions for overcoming or avoiding such obstacles
- Discuss responsibilities of applicants who obtain approval of a marketing application
Lesson Titles
- Lesson 1: Basic Concepts
- Lesson 2: ANDA Submission Process
- Lesson 3: Postapproval ANDA Maintenance
This course is also included in:
