November 24, 2014 LDT Battle Lines Drawn: FDA Announces Jan. 8-9 Public Meeting on LDT Framework; Lab and Medical Groups Send Letter to FDA Commissioner Urging Notice-and-Comment Rulemaking; FDA and Patient Groups Advocate for LDT Framework on Hill By Jamie K. Wolszon -

A battle is brewing between proponents and opponents of FDA’s plans to actively regulate Laboratory-Developed Tests (LDTs), with several developments involving both camps in the past two weeks.  On the proponents’ side, on November 21, FDA announced that it will be holding a public hearing on January 8-9, 2015 at the National Institutes of Health (NIH) campus in Bethesda, Maryland.  That announcement came on the heels of a November 18 briefing on Capitol Hill by FDA, the Centers for Medicare & Medicaid Services (CMS) and patient groups advocating for the draft guidances (see our previous post here). 
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