On September 10, 2015, GRAY SHEET (a subscription trade journal, here) reported that across both political parties and in both House and Senate, the FDA probably will be left to develop a final LDT guidance without interference. On background, staff indicated the Hill might act after the FDA has acted, but not before.
At a Next Generation Sequencing conference in Washington in mid-August 2015, FDA speakers remarked that public comment on the FDA LDT draft guidance had been considered thoroughly, the draft guidance had been revised, and it was working its way through approval and release channels at the FDA and/or executive branch.
