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
Marginal LDT scenarios could be where the FDA focuses on next, a lawyer notes
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
The agency has approved fewer than 10 tests in the past three years, but a new pipeline of AI-powered products is expected to emerge soon
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Prenosis claims its test can detect the presence of the often deadly condition within 24 hours of a hospitalization
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
Whether the MiniDraw™ device dredges up memories of Theranos’ failed tech remains to be seen.