As of last Thursday, April 12, 2017 and going back to a rainy night in Cleveland on November 2, 2016, the past 162 days have seen at least 3 things most Americans, and perhaps many across the world thought they would never see happen in their...

medpagetoday.com posted a brief but concise article earlier this week on the issue of FDA regulating laboratory developed tests (LDTs). While the FDA has had the ability to regulate these tests since 1976, largely once regarded as "simple and...

New Webinar from The Dark Report — Wednesday, September 17, 2014 Our distinguished panel explains how the FDA’s draft guidance is a road map that labs can follow immediately to optimize how the FDA treats their most important...

In this series of posts on Laboratory Developed Tests (LDTs), I discuss the history of the regulation of LDTs and impending changes (posts #1 and #2).  I also discuss possible criteria that pathologists, treating physicians, and...