R A 602 - Food and Drug Law

Units: 3

Grading Method: LCR: Letter Grade with Cr/NC available. The grading default for the class will be letter grade, but students can opt to take it for Cr/NC

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.

Maximum Credits: 3