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 ...

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

REEDLEY, Calif. (KFSN) -- The fallout continues over an illegal lab uncovered in Reedley, which contained hazardous materials, biological agents, and nearly one-thousand mice. Local leaders are ...

The Food and Drug Administration released a final rule on Monday strengthening its authority over laboratory developed tests (LDTs), advancing a policy that has drawn fierce opposition from healthcare ...

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.

IVDs are essential for disease detection, personalized treatment, and public health, driving growth in the global diagnostics ...