I received a marketing circular last week from the organizers of the 2016 Personalized Medicine World Conference that included a message from the conference chair, Atul Butte, who made the following statement: “The high volume of targeted drugs recently approved...
During a recent panel discussion regarding the regulation of laboratory-developed tests (LDTs), Elizabeth Mansfield, Deputy Director for Personalized Medicine at FDA, announced that FDA will be increasingly focused on what she called “complementary...
An FDA official recently stated that the final version of the draft guidance regarding regulation of laboratory-developed tests (LDTs) is not likely to be released before the end of this year. Elizabeth Mansfield, director of personalized medicine at the FDA’s...
“It’s not quite ‘circle-the-wagons’ time around here, but there definitely isn’t much appetite for trying new things.” This was the assessment shared with me recently by an executive at a leading diagnostics company when asked to...
There have been a number of interesting review articles recently discussing the state of the art for personalized/precision medicine, and it’s clear that most commentators believe we are still very much in the early days. Having just completed a quick review of...
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