Tag: LDTs

162 Days of Change

| April 17, 2017 | 1 Comment

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 lifetimes. That rainy night in Cleveland started the clock […]

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FDA Delays Final Guidance on Regulating LDTs

| November 25, 2016 | 0 Comments

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to regulate these tests since 1976, largely once regarded as “simple and scarce” as the article mentions, not before a draft guidance issued in 2014 has the FDA […]

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FDA Prepares to Regulate LDTs: What You Must Know, What Your Lab May Need to Do, and Why You Should Prepare Now

| August 25, 2014 | 0 Comments

New Webinar from The Dark Report — Wednesday, September 17, 2014 Our distinguished panel explains how the FDA’s draft guidance is a road map that labs can follow immediately to optimize how the FDA treats their most important LDTs There’s big news ahead if your lab performs laboratory-developed tests (LDTs)! On July 31, the Food and […]

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Laboratory Developed Tests – Part 1

| January 11, 2011 | 0 Comments

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 healthcare systems could use to determine which tests are well validated (post #3). I think there are at least […]

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