FDA approval of novel therapies were considered as signs of personalized medicine in the community of real progress in the development of personalized medicine, approval FDA, these drugs, along with a companion diagnostic, suggested a shift in thinking and practice in the management of the agency. In addition to regulatory issues, many believe compensation system archaic, dispersed, unpredictable, and an inordinate amount of time. Many doubt that the traditional compensation model was relevant in the era of personalized medicine, and who should pay the costs of the tests needed to identify sometimes small number of patients who could benefit from expensive targeted drugs. This case focuses on a range of opportunities and uncertainties surrounding these regulatory and reimbursement issues. "Hide
by Richard G. Hamermesh, C Norman Selby, Philip Andrews Source: Harvard Business School 20 pages. Publication Date: November 1, 2012. Prod. #: 813037-PDF-ENG
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