Emerging Product Categories in the Regulation of Drugs and Biologics

RGA 6235 4 Quarter Hours
Course Level CPS - Graduate
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.

Prerequisites

Students should refer to the CPS Prerequisite Table for course prerequisite and corequisite information.

 

Course Sections

Section 01
CRN 20337
Session Winter 2018 CPS Quarter - Full Term
Class Meeting Dates 01/08/2018 to 03/31/2018
Instructor Jennifer Kelley
Campus Online Campus
Course Format Online
Costs Course Cost: View Tuition Rates | Books: Visit NU Bookstore Site
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