LEGAL GUIDE TO FOOD & DRUG ADMINISTRATION
This course is designed to provide students with an in-depth understanding of the legal framework guiding the operations of the Food and Drug Administration (FDA). Students will examine the processes of creating, implementing, and interpreting laws and regulations pertaining to food, drugs, cosmetics, and medical devices in the United States. This advanced course will delve into complex topics such as FDA’s enforcement powers, regulatory challenges, and the role of the legal environment in shaping public health outcomes.
Understand and explain the structure, function, and history of the FDA.
Discuss and critically analyze the legislative framework that governs the FDA.
Explore and interpret FDA regulations in relation to food, drugs, cosmetics, and medical devices.
Understand and evaluate the enforcement powers of the FDA and how they are implemented.
Identify and critique the contemporary regulatory challenges faced by the FDA.
Understand the relationship between FDA regulations, legal issues, and public health outcomes.