Course Description:
Any lawyer employed by an FDA-regulated manufacturer in any capacity, or who seeks to represent or advise an FDA-regulated manufacturer, including not just regulatory law but also contract negotiation or patent prosecution, should be acquainted with the regulatory milieu in which the company operates. Topics for this course include: FDA history, structure, regulatory environment; intended use of food, labeling, misbranding, adulteration, safety of constituents; dietary supplement labeling, identity and quality, and safety; labeling of conventional food and dietary supplements; regulation of drugs, prescription drug advertising, good manufacturing practices; new drug approval, biological products, generic drugs, exclusivity, OTC drugs; device classification, PMAs, 510(k)s, user fees; cosmetic vs. drug, color additives, adulteration and safety of ingredients, federal preemption of state law; and enforcement. Approved IP LL.M. course.