FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
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…