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.


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


Course Sections

There are no current sections scheduled for this course. Undergraduate course numbers changed beginning with the Fall 2016 term. Please make sure you are using the current course number.
Next Term Starts
  • Summer Graduate
    Jul 10, 2017 (4-, 6-, and 8-week classes)
    Aug 7, 2017 (4-week classes)
  • Fall Undergraduate
    Sep 4, 2017 (7.5- and 15-week classes)
    Oct 25, 2017 (7.5-week classes)
  • Fall Graduate
    Sep 18, 2017 (6- and 12-week classes)
    Oct 30, 2017 (6-week classes)

Academic Calendar

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