RGA 6490 — Emerging Trends and Challenges in Regulatory Affairs
2 semester hoursGraduateLecture
Examines the development and commercialization pathways for several emerging categories of drug and biologic products that are not formally classified by the U.S. Food and Drug Administration, including new OTC products, neutraceuticals, nanotechnology products, and precision medicine-based therapies. Evaluates the reasons why regulatory paradigms for these products are not well established and analyzes how the relatively amorphous nature of these paradigms has impacted commercialization of these product categories in the U.S. market. Offers students an opportunity to gain a better understanding of how and why new product categories continue to emerge as existing regulatory classifications continue to evolve.