Monday, March 13, 2017

"Even before the 2014 draft guidance for LDT, many laboratorians saw the FDA as encroaching on the practice of laboratory medicine."

Ken GatterMD, JD
From the Department of Pathology, School of Medicine, Oregon Health Sciences University, Portland.


"Even before the 2014 draft guidance for LDT, many laboratorians saw the FDA as encroaching on the practice of laboratory medicine."



cf., 

http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2012-0077-ED

and

http://www.archivesofpathology.org/doi/pdf/10.5858/arpa.2013-0020-ED


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