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FDA reports fragments of avian influenza found in US commercial milk supply
World Socialist Web Site· 22 minutes agoThe detection of H5N1 viral particles by the Food and Drug Administration (FDA) in commercially sold...
FDA brings lab tests under federal oversight in bid to improve accuracy, safety
Market Watch· 9 hours ago“The agency cannot stand by while Americans continue to rely on results from these tests without...
ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices
KTLA-TV Los Angeles· 9 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, doctors warn about compounded Ozempic. What we found at metro weight loss clinics
WSB Cox articles via Yahoo News· 4 days agoPharmacies make compounded Ozempic by combining two or more drugs. The FDA allows this because...
FDA finalizes lab developed test rule despite industry opposition
MedTech Dive via Yahoo Finance· 20 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...
WTNH-TV New Haven· 11 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 ...
Small Business - The Brewton Standard | The Brewton Standard
The Brewton Standard· 9 hours ago(NYSE: PFE) announced today the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for TIVDAK® (tisotumab vedotin-tftv ...
FDA finalizes rule to bring lab-developed tests into the regulatory fold
FierceBiotech· 17 hours agoThe FDA has finalized its regulatory rule that aims to bring laboratory-developed tests more in-line...
FDA moves to regulate some tests it says may be unreliable
Anchorage Daily News· 8 hours agoThe agency says inaccurate results may force patients to unnecessarily start a new treatment or...