Settling on a Framework for LDT Regulation: Update

Update: The FDA post-election statement on delaying implementation of the agency's draft guidance on LDTs affirms the status quo - for now. The delay allays the concerns of some stakeholders about potential effects of greater FDA involvement in LDT regulation, such as slowing innovation in diagnostics and patient access to the most advanced diagnostics and, [...]

Settling on a Framework for LDT Regulation: Update 2018-08-14T21:10:39+00:00
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