Emerging Product Categories in the Regulation of Drugs and Biologics

Catalog description

Examines the development and commercialization pathways for several product categories, including new over-the-counter (OTC) products, neutraceuticals, nanotechnology products, and personalized medicine-based therapies. These emerging categories of drug and biologic products are not formally classified by FDA from a regulatory perspective. Evaluates the reasons why the 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.