News on issues related to managing clinical laboratories.
ACLA filed a motion arguing that HHS' PAMA data collection process is flawed. It follows a July decision that overturned a lower court's dismissal of ACLA's lawsuit.
The agency has proposed rolling back exemptions gained in a 2018 revision of the rule that labs say are key to maintaining access to molecular testing.
With the certification, the Silicon Valley-based company aims to roll out its AvaGen test for keratoconus and corneal dystrophies beginning this quarter.
While some groups have communicated their concerns directly to the agency, stakeholders have also formed a new coalition to publicly take issue with FDA's actions.
Fresenius was alleged to have unnecessarily tested some dialysis patients for hepatitis B surface antigen and billing Medicare for the tests.
