FDA Issues Four Warning Letters to Lab Companies in Less Than Two Months
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
Laboratory diagnostics manufacturers receive regulatory scrutiny for issues including marketing, quality, and unapproved changes to tests
From - Laboratory Industry Report
On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to…
From - Laboratory Industry Report
Last month, the FDA floated a plan to overhaul and modernize the 510(k) premarket review pathway allowing for faster, safer approval of medical devices, including…
From - Laboratory Industry Report
The FDA broke new ground by allowing marketing of Adaptive Biotechnologies' ClonoSEQ assay, a next generation sequencing (NGS)-based test for…
From - Laboratory Industry Report
Heads up to any lab that's subject to oversight by the CBER, i.e., the FDA agency responsible for regulating biological products for human use…
From - Laboratory Industry Report
On Aug. 3, the Food and Drug Administration heated the long simmering controversy over FDA regulation of laboratory developed tests (LDTs) to full boil by submitting…
From - Laboratory Industry Report
Last November, the FDA raised eyebrows with a notice for public comment proposing to make it easier to bring new…
From - Laboratory Industry Report
Last month, the FDA finalized a pair of guidance documents designed to liberalize and speed up approval of new next-generation sequencing…
From - Laboratory Industry Report
April 13 was a red letter day for FDA guidance with the agency issuing a pair of final guidances on the design, development and validation of next-generation sequencing…