Course Description
An overview of laws and regulations governing development, manufacturing, and commercial distribution of drugs, biologic, medical device products, and animal health products and how they relate to the pharmaceutical, biotechnology, and medical device industry. This includes domestic regulatory requirements and various regulatory agencies and their jurisdiction.
Additional Requirements for Graduate Students:
Graduate law students will not be doing any extra work beyond
that required of the Juris Doctor students. J.D. students are
post-baccalaureate students and the workload expected of them is
the same workload expected of post-baccalaureate graduate
students. Law students are professional students, not
undergraduate students. Graduate law students are primarily
international lawyers seeking expertise in the American legal
system. This expertise is gained through exposure to Juris
Doctor courses.
Athena Title
Food and Drug Law
Semester Course Offered
Offered fall and spring
Grading System
A - F (Traditional)
Course Objectives
Upon completion of this course, students will be able to: 1) Demonstrate an appreciation for federal regulation of pharmaceuticals, biologics, medical devices, combination products, and animal health product-related laws, regulations, and guidelines 2) Explain how the FDA enforces the law and regulations; 3) Identify legal issues surrounding product liability, import/export, and post-marketing surveillance obligations. 4) Locate and reference information used in the role of regulatory affairs professional 5) Interpret FDA laws and regulations and write persuasively about the interpretation 6) Understand the history of key regulations, including the development and evolution of the FDA regulatory process 7) Demonstrate an appreciation for the subjective and interpretative aspects of regulations
Topical Outline
1. Historical Background of the Regulation of Food and Drugs 2. Foundational Principles Surrounding the Jurisdiction of the FDA 3. The Boundaries of FDA Jurisdiction 4. FDA Regulation of Human Drugs 5. FDA Regulation of Human Clinical Trials 6. FDA Filing Process 7. Exceptions and Variations to the Standard FDA Approval Process 8. Post-FDA Approval Obligations 9. Regulation of Prescription Drugs 10. Regulation of Drug Labeling and Marketing Activities 11. Animal Drugs