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Home » FDA’s Califf calls on labs to ‘wake up and develop better tests’
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FDLI Annual Meeting

FDA’s Califf calls on labs to ‘wake up and develop better tests’

May 15, 2024
By Mark McCarty
The U.S. FDA’s final rule for regulation of lab-developed tests promises to remain controversial for the foreseeable future, but FDA commissioner Robert Califf said that many of these tests have been shown to be less than adequately reliable. Califf said that one of the effects of the final rule is that it will force clinical labs to “wake up and develop better tests,” if only because compliance and enforcement regimes will soon be applied to clinical labs.
BioWorld MedTech Regulatory U.S. FDA

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