Fighting the FDA’s Final Rule on LDTs
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
Direct-to-consumer (DTC) genetic testing has risen in popularity in recent years—but is it all it’s cracked up to be?
For clinical labs, the proposed law could bring more consistency to test ordering
The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation
What clinical laboratory professionals need to know about healthcare provision for transgender and nonbinary patients
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
Though potential FDA LDTs regulation has drawn a lot of attention, other efforts could also have long-term effects on how labs do business.
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.
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.