Next Steps: With LDT Final Rule Now Null, Industry Groups Urge Lab Managers and Pathologists to Advocate for Change
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
CEO Laurie Menser discusses the Association for Molecular Pathology’s court case against the FDA’s rule on laboratory-developed tests.
A lawsuit by a group of herring fishermen upended 40 years of legal precedent regarding how federal agencies interpret statutes
Experts explain what the phase-in process will look like—and how labs can get ahead of the game.
Curious about how laboratory-developed tests are regulated in other countries? We compare in-house test guidance across six regions
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.