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
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
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