In one of the first demonstrations of the impact of last year’s Loper Supreme Court decision on challenges to agency ...
Platinum-Free Systemic Therapy in First-Line Metastatic Urothelial Carcinoma: Mirage or Oasis in the Platinum Desert? Cancer predictive or diagnostic assays, offered as Laboratory-Developed Tests ...
The onset of COVID-19 proved to be a real-time stress test of America’s clinical testing system. The experience exposed several flaws in the system that policymakers should address, specifically, ...
See Report Implementation of Protecting Access to Medicare Act of 2014, P.L.113-93 (changes to reimbursement for clinical laboratory services). Policies impacting Medicare coverage and reimbursement ...
Medical Device Network on MSN
FDA scraps ‘Final Rule’ classifying LDTs as medical devices
The FDA’s move to nix its ‘Final Rule’ comes in response to the legislation’s strike down in a Texas court in March 2025.
After introducing a user fee reauthorization draft in May, the Senate recently added a new proposal that would revamp the Food and Drug Administration’s regulation of clinical tests and diagnostics.
A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean ...
This article is the third in Microbiologics’ series on Optimal QC in the Clinical Laboratory. Previously, in this series we highlighted the importance of external and third-party quality control ...
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