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FDA brings lab tests under federal oversight in bid to improve accuracy, safety
Market Watch· 3 hours ago“The agency cannot stand by while Americans continue to rely on results from these tests without...
FDA, doctors warn about compounded Ozempic
WHIO-TV 7 Dayton· 2 hours agoIt’s a popular drug that millions of people are taking to lose weight, but the federal government and doctors are warning users about some versions of...
ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
FOX 4 Kansas City· 3 hours agoA final FDA rule regulating laboratory-developed tests (LDTs) as medical devices does not address serious concerns raised by ARUP Laboratories and the clinical laboratory ...
FDA finalizes rule to bring lab-developed tests into the regulatory fold
FierceBiotech· 11 hours agoThe FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line...
FDA finalizes lab developed test rule despite industry opposition
MedTech Dive via Yahoo Finance· 14 hours agoLDTs are in vitro diagnostics that are used within a single clinical laboratory, traditionally a...
...The Association for Diagnostics & Laboratory Medicine (formerly AACC) opposes FDA ruling on...
WPRI Providence· 5 hours agoWe agree with the FDA that laboratory developed tests have evolved since the CMS regulations for them were first implemented and that it would benefit patients...health is ...
FDA finalizes rule to increase oversight of lab tests
CQ Politics· 13 hours agoThe rule effectively reclassifies tests developed and performed in a lab as medical devices for the...