Northeastern University College of Professional Studies
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The Business of Medicine and Biotechnology

BT3500 / 4 q.h.

Starting with the fall 2009 term, this course will be renumbered as BTC 6260.


Developing new drugs, biologics, and medical devices involves much more than simply showing a clinical benefit. 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 American 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. In this course, students use group discussions and debates to consider current case studies in order to understand how and why certain medical products succeed while others do not. The course concludes with a group debate where students recreate an FDA panel meeting to try and understand the FDA approval process.

There are no current sections scheduled for this course number.
Please note that courses have been assigned new numbers beginning with the fall term.
Please check the new course number for course availability.