ACLA Sues FDA Over Regulation of Laboratory-Developed Tests—in Texas
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
The choice of venue was likely inspired by the longstanding anti-regulatory stance of the state's federal judges.
New policies aim to better protect data against increasing cyberattacks, but academics say the changes will limit critical research
How widespread is corruption in the lab—and what can be done to combat it?
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
The ALZpath DX assay is less invasive than other diagnostic tests, and may give patients diagnosed with Alzheimer’s more time to plan
The impending legislation that may determine Medicare lab fees from 2025 onward
Recent enforcement actions include convictions and guilty pleas for false claims-related allegations involving toxicology labs.
Formulating queries that are compliant, informative, and effective—even in tricky situations.
Program outlined in a recently introduced bill would test AI’s effectiveness in detecting suspect payments for diagnostic tests and DME.
How clinical laboratory professionals can advocate for legislative and regulatory improvements
Joyce Gresko, partner at Alston & Bird, discusses the latest on PAMA and what will likely need to happen for SALSA to pass in 2024.