The FDA approvals of innovative therapeutics were seen as hints in the personalized medicine community of real improvement in the development of personalized medicine; The FDA's acceptance of such drugs, along with company diagnostics, indicated a shift in thinking and regulatory practices at the bureau. Past the regulatory questions, many considered the compensation process archaic, spread, unpredictable, and unnecessarily time consuming.
Many questioned whether the conventional models of compensation were applicable in the age of personalized medicine, and who should be covering the cost of evaluations needed to recognize the occasionally few of patients who could benefit from drugs that were high-priced targets. This case targets the array of possibilities and the ambiguity surrounding these regulatory and compensation issues.
PUBLICATION DATE: November 01, 2012 PRODUCT #: 813037-HCB-ENG
This is just an excerpt. This case is about INNOVATION & ENTREPRENEURSHIP
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