CLIA

Oversight of the laboratory testing field must balance safety with speed and innovation

What steps should your lab take in response to shifting LDT oversight?

Join Today's Clinical Lab and a panel of regulatory and industry experts as they explore what’s ahead in laboratory compliance—and what labs need to know right now

Anthony Killeen reacts to news that influential committee has been dismantled by the US federal government

Prior to the MSDA Test, disease management in MS relied primarily on clinical assessments and MRI

The FDA LDT rule would have imposed unnecessary burdens on laboratories, adding requirements beyond existing CLIA regulations

Company to commercialize PanCystPro, including establishing an early access program and completing a clinical utility trial in 2025

Experts Julie Ballard and Lindsay Strotman help you navigate the complexities of FDA, CLIA, and ISO standards for the clinical lab

New CLIA-certified lab ensures seamless transition from early assay development and testing to full companion diagnostics commercialization

In overturning the Chevron case, justices diminish the power of federal agencies like the FDA