Special Analysis: Two Key Legislative Initiatives Labs Should Know About
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
Joyce Gresko, partner at Alston & Bird, discusses the latest on PAMA and what will likely need to happen for SALSA to pass in 2024.
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
Genialis CEO and co-founder Rafael Rosengarten, PhD, discusses key 2023 AI developments and what they could mean for laboratories.
An overview of PAMA and key aspects lab compliance officers should be aware of to help ensure compliance.
On Oct. 28, the US Department of Health and Human Services served notice that it plans to repeal a controversial Trump rule.
From - Lab Compliance Advisor
While FDA oversight over new diagnostic tests is perfectly acceptable, what is objectionable is the…