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.
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, the FDA issued final guidance allowing companies to submit for simultaneous review for the clinical trial.
A new FDA Technical Specifications document (Tech Doc) lists recommendations for sponsors on use of next generation sequencing data to secure approval of new antiviral drugs and related diagnostic tests providing crucial guidance on six key issues.
From - Laboratory Industry Report
Laboratory diagnosis of Lyme disease is based on detecting the presence of antibodies against…
From - Laboratory Industry Report
Over the past several years, the FDA has issued Emergency Use Authorization (EUA) for over a dozen different tests for…
From - Laboratory Industry Report
The FDA broke new ground by clearing a pair of STD screening assays for detecting chlamydia and gonorrhea for use with extragenital specimens, specifically from the…
From - Laboratory Industry Report
After a couple of years of dormancy, the FDA laboratory developed test (LDT) enforcement volcano stirred on…
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…