LAW 2832 - Law of Medical Product Discovery, Development and Commercialization
This course will explore the influence of law and regulation in the United States and other jurisdictions on the pharmaceutical and biotechnology industry. The central focus will be the pathway of the discovery, development, and commercialization of new medicines and the effect of various stakeholders, legal disciplines, governmental structures, and globalization on that pathway. Students will learn the lawyer’s role in negotiating agreements, resolving disputes, making policy, and otherwise building consensus in this complex setting. Topics include the history of food and drug and related law, the evaluation of drug safety and efficacy, market exclusivity and market protection, and the roles of the FDA and other U.S. and non-U.S. government agencies. Students will have the option of taking the final examination or writing a paper.
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