Personalized medicine may use devices and assays that identify sex-related differences. For example, a device or an assay may determine if a cancer patient harboring a particular genetic variance will or will not respond to a...more
The past decade has seen incredible progress for the scope and impact of personalized medicine. Just ten years ago, tamoxifen and trastuzumab were among the few drugs that were routinely paired with a companion diagnostic...more
Personalized medicine is changing the paradigm of the research, development and delivery of health care. The Personalized Medicine Coalition (PMC), a consortium of interested stakeholders that seeks to promote the...more
Next generation sequencing (NGS) promises to transform the delivery of health care by providing in one test diagnostic and prognostic information that had previously only been available in multiple analyses. One application...more
FDA report demonstrates support for personalized medicine and more efficient regulatory pathways.
In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs...more
In a report released on October 29, 2013, the U.S. Food and Drug Administration (FDA) announced its continued commitment to advancing personalized medicine. “Paving the Way for Personalized Medicine: FDA’s Role in a New Era...more
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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