The U.S. Department of Food and Drug Administration (“FDA”) has previously announced an interest in regulating diagnostic tests used in providing personalized medicine clinical care. Interested stakeholders such as the...more
Last month, the U.S. Food and Drug Administration released its annual report on innovative drug approvals, noting that the agency approved 35 novel medicines in FY 2012. The 35 approvals equaled the number of approvals for...more
Patenting diagnostic methods is more challenging in the wake of the U.S. Supreme Courts Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012) (Prometheus) and the USPTO’s application of the...more
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- Six Things to Think About as Technology Advances
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- Recent Health Care News You Should Know About
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- Deep Thoughts for the New Year: Ethical...more
Originally published in Medical Research Law & Policy Report, 12 MRLR 4, 01/02/2013.
Regardless of what happens with the fiscal cliff negotiations in Congress and the Obama administration, research funding will...more
Increasingly, the development of new pharmaceuticals utilize genetic information to stratify patient subpopulations and/or predict efficacy and adverse events – the development paradigm of personalized medicine....more
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