White House sets April target for finalization of FDA rule on lab developed tests

MedTech Dive December 8, 2023
Nick Paul Taylor

TD Cowen analysts said it is “unclear if and when FDA will finalize the rule as it has faced considerable opposition.”

Dive Brief:

The White House expects the Food and Drug Administration to finalize its contentious proposed rule on laboratory developed tests (LDTs) in April.
Officials included the FDA’s proposal on the regulatory agenda for fall 2023 and put April as the final action date. The timeline gives the FDA months to work through an avalanche of feedback and revise its draft to create a final rule.
TD Cowen analysts, who flagged the April target in a note to investors, said it is “unclear if and when FDA will finalize the rule as it has faced considerable opposition and...

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2023-12-08T20:46:17-05:00