The Advertising and Promotion of Drug & Medical Device Products

Provides a comprehensive analysis of the regulatory and legal guidelines and standards applicable to the promotion of drug and medical device products in the U.S. market. Includes regulations and policies of the FDA, FTC, DEA, PHS, Office of the Inspector General (OIG), as well professional guidelines of relevant organizations including Advamed, ACCME, ACP, PhRMA and the AMA. Also explores marketing issues specific to brand-name (prescription and OTC), generic, and compounding pharmacy contexts, including Continuing Medical Education, Advertising of Compounding Products, Off-Label Promotion, Gifts to Physicians, and Direct-to-Consumer Advertising. Uses advertisements and case studies, including notable enforcement actions by the FDA and FTC, to illustrate and discuss subjects of interest.

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