FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
CAP and AMP officials weigh in on plans to push for a legislative- or CLIA-based approach to future LDT oversight
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Pre-submission and Q-Submission meetings apparently have been halted, for now
The 15-minute assay to detect sepsis and assess its severity and risk is expected to get full FDA approval by 2026
Regulatory expert Julie Ballard shares her thoughts on the most useful resources for labs as they get ready to comply with Stage 1
Although the timelines have been extended several times, IVDR complexity has created a concerning bottleneck in the approval process
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent