Food, Drug and Device Law – 6402

This course focuses primarily on the regulation of foods, drugs, and medical devices, by the U.S. Federal Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). The format for the course is lecture, discussions, and collaborative exercises. Goals and desired learning outcomes: Students will learn about the statutory framework involved in regulating foods, drugs, and medical devices, with particular emphasis on the U.S. Federal Food, Drug and Cosmetic Act (FDCA) and the USDA as it applies to food. Students learn how the FDA, USDA, and courts interpret and enforce related statutes and regulations and will gain insight into FDA decision-making processes and policies. This course is intended to improve student legal reasoning skills, writing, and presentations skills. Students will analyze and interpret laws and regulations through case law and present to classmates on FDA and the USDA regulatory topics.