2:28 PM
Dec 06, 2018
 |  BC Extra  |  Politics & Policy

Bipartisan bill would revamp diagnostics regulation

Champions of legislation in Congress to overhaul diagnostics legislation released a draft bill Thursday that scraps many features of a draft bill released last year and incorporates a different approach proposed by FDA.

If it is enacted, the Verifying Accurate, Leading-edge IVCT Development (VALID) Act would create a completely new system for regulating diagnostics, and would resolve controversy that has raged for over a decade about FDA’s authority to regulate laboratory developed tests (LDTs).

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