R A 602 - Food and Drug Law

Units: 3

Prerequisite(s): R A 601.

Laws and regulations enforced by the FDA for biotechnology, medical device, pharmaceutical, and related industries. Federal Food, Drug, and Cosmetic Act, Freedom of Information Act, related laws, and the U.S. legal system. Laws and regulations affecting biologics, cosmetics, devices and diagnostics, drugs, foods, tobacco products, and veterinary products. Combination products, import/ export requirements, international regulations, orphan products, and product liability.