Combination Products and Convergence

RGA 6211 4 Quarter Hours
Course Level CPS - Graduate
Description Examines the development of combination products, with an eye toward understanding FDA and international agency oversight, regulatory classifications, and interpretations of guidance documents. Medical products, no matter how well designed, can only do so much to address clinical problems today. In order to satisfy the therapeutic needs of the future, medical devices will be used in combination with drugs and biologics. This category of products covers everything from transdermal patches to drug-eluding stents. Tissue engineering, for example, employs cells (biologics) producing proteins (biotech drugs) growing on polymer substrates (medical devices). Through a detailed study of real-world case studies, offers students an opportunity to weigh the larger economic, social, political, and clinical dimensions of combination products.

Prerequisites

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.
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