Diagnostics regulatory reform draft legislation being considered by a House subpanel would not result in more accurate and effective laboratory developed tests (LDTs), or even streamline any new molecular-based diagnostics’ passage to market, both FDA’s Jeffrey Shuren and CMS’ Patrick Conway argued before the House Energy and Commerce Health Subcommittee on Nov. 17.
Instead, the two officials told Subcommittee Chairman Joe Pitts, D-Pa., that the House proposal
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