The Business of Medicine and Biotechnology
BTC6260 / 4 q.h.
Formerly BT 3500.
Considers current case studies in order to understand how and why certain medical products succeed while others do not. Understanding how integrating cost, reimbursement, intellectual property, product liability, and FDA issues into an overall product development strategy is vital in bringing a new medical product to the U.S. market. And in light of high-profile product failures such as VIOXX and others, reimportation of drugs, reuse of single-use medical devices, and the impact of generic biologics, keeping your medical product on the market can be as much of a challenge as getting it there. The course concludes with a group debate where students recreate an FDA panel meeting to try and understand the FDA approval process.
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