The number of publications that describe studies involving new biomarkers increased significantly during 2014, with 37% more such studies in 2014 than 2013. This figure shows the total number of publications each year that include the words “novel...
For those who were willing to listen through a lot of repetitive presentations during last week’s FDA workshop covering the Agency’s proposed regulation of LDTs, some interesting points were made by at least a few of the presenters and panelists. FDA...
JAMA published two Online First opinion pieces on January 5, covering each side of the proposed FDA regulation of LDTs. Pro-Regulation Opinion The opinion in favor of FDA regulation was written by Joshua Sharfstein, MD, from the Department of Health and Hygiene. Dr....
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