FDA Watch: New Test for Esophageal Conditions is Coming to the US
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
UK-developed assay that uses a sponge appears to reduce the need for more invasive endoscopies.
From - Laboratory Industry Report
For the second time in less than a year, the FDA indefinitely delayed a controversial rule expanding its authority to regulate off-label marketing…
From - Laboratory Industry Report
A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including…
From - Laboratory Industry Report
The phrase "most exciting FDA laboratory developed test approvals of the year" is no longer an oxymoron. The agency remains glacial in tempo…
From - Laboratory Industry Report
For years, the lab industry has been pressing the FDA to relinquish its rigorous oversight of direct-to-consumer (DTC) genetic health tests…
From - Laboratory Industry Report
Dr. Alberto Gutierrez is the 2017 recipient of the Kellison Lab Industry Distinguished Service Award. Dr. Guitierrez retired in August after…
From - Laboratory Industry Report
The diagnostics community is saying goodbye to a frenemy of 25 years. On Aug. 29, Alberto Gutierrez, director of the…
From - Laboratory Industry Report
Zika made the FDA headlines this month, with two more tests receiving emergency use authorization…
From - Laboratory Industry Report
The FDA made a stir in May by approving a cancer drug (Keytruda (pembrolizumab) PD-1/PD-L1 inhibitor from Merck) administered on the basis of a…
From - Laboratory Industry Report
The FDA budget pot continues to boil. In March, the Trump administration proposed a controversial provision to double the medical user fees that diagnostics, medical device and…