Combination Products and Convergence

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. Prereq. RGA 6100, RGA 6201, or RGA 6202.

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