Pharmaceutical & Life Sciences News

Diagnostic Test Bill Likely Out Next Summer: House Aide

Dec. 10, 2018, 10:37 PM

Legislation to give the FDA new authority over medical screening tests developed in individual clinical laboratories will likely come out next summer, a House staffer told Bloomberg Law.

Rep. Larry Bucshon (R-Ind.) released earlier this month the latest draft of a bipartisan bill to overhaul the Food and Drug Administration’s oversight of all diagnostic tests that often drive medical treatment decisions. The latest draft bill largely replaces an earlier version written by Bucshon and Rep. Diana DeGette (D-Colo.) with a proposal submitted by the FDA this summer.

At the heart of the issue is whether and how the FDA should...

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