Law 792:  Food and Drug Law

This course explores the full spectrum of federal regulation of products under the Food and Drug Administration (FDA) jurisdiction. It encompasses the regulation of human food, drugs, biological products, medical devices, cosmetics, tobacco products, and more. The course will also delve into contemporary topics such as vaccine regulation (e.g., COVID-19 vaccines), compassionate use of investigational medical products, and the regulation of artificial intelligence and digital health products.

Sequence and Prerequisites: None.

Course Evaluation: Students are required to prepare an original research paper on a topic covered in this course and present their chosen topic for discussion. This research paper may fulfill the upper-level writing requirement as per ABA Standard 303(a). Students interested in this option should email the Professor.