FDA-CMS collaboration aims to accelerate Medicare coverage determinations of certain medical devices
In both cases, the diagnostic tests report results back within 15 minutes
But anti-regulatory stance taken by Trump administration could serve as a potential obstacle in the effort
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From – Laboratory Industry Report
The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the…
From – Laboratory Industry Report
Zika made the FDA headlines this month, with two more tests receiving emergency use authorization…
From – Laboratory Industry Report
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a…
From – Laboratory Industry Report
The FDA budget pot continues to boil. In March, the Trump administration proposed a controversial provision to double the medical user fees that diagnostics, medical device and…
From – Laboratory Industry Report
Instead of the budget cuts the President asked for, the newly approved federal government spending plan increases FDA funding by…
From – Laboratory Industry Report
A notable FDA Section 510(k) approval was granted before the close of 2016 for Foundation Medicine’s FoundationFocus CDxBRCA, a next-generation sequencing-based companion diagnostic test…
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