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FDA Puts Lab-Developed Test Oversight Plans On Hold

After years of wrangling over lab-developed test regulations with laboratory lobbyists, FDA has put its plans to finalize a guidance that lays out its oversight framework for LDTs on hold as a new Congress and a new deregulation-focused president-elect is set to take the helm.

PCR strip test tubes and micropipette in genetics laboratory. Toned photo

[Editors' note: This story was updated Nov. 21 to clarify that FDA's email to stakeholders did not explicitly state that the agency is delaying the final LDT guidance.]

Six years after US FDA announced its plans to develop a framework for actively regulating laboratory developed tests (LDTs), the agency has decided to hold back from issuing...

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