In a ruling handed down last month in the Eastern District of Texas, Judge Sean Jordan stuck a dagger in the heart of a US Food and Drug Administration final rule that would have regulated laboratory-developed tests, or LDTs, as medical devices.
End Of The Road? Court LDT Decision May Leave FDA With Few Options
Now that a federal judge has ruled the US FDA exceeded its authority by unilaterally assuming regulatory oversight of lab-developed tests, what’s the agency’s next move? And does it really have one?
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