Disease Advocates To Congress: Work With FDA On LDT Oversight Plan

January 27, 2017 at 1:47 PM
Over 30 disease advocacy groups wrote to Senate Majority Leader Mitch McConnell (R-KY) and Minority Leader Chuck Schemer (D-NY) Tuesday (Jan. 24) urging Congress to work with FDA to craft a regulatory framework for laboratory developed tests (LDTs). The groups argued that increasing LDT complexity warrants analytical validity oversight, which they feel is lacking from CMS’ lab-oversight program under CLIA. The push comes as laboratories generally argue that FDA shouldn't play a role in overseeing LDTs. FDA announced in November...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.