FDA is upping its response to address the novel coronavirus outbreak. The policy is aimed at laboratories seeking to develop diagnostic tests for the coronavirus. The policy allows laboratories to develop and begin to use the diagnostics be

NEW YORK The US Food and Drug Administration on Friday granted Emergency Use Authorization to Luminex for the firms NxTag CoV Extended Panel to detect SARS-CoV-2 virus nucleic acids in nasopharyngeal swab specimens. High-complexity molecula

NEW YORK Avellino Labs on March 25 received Emergency Use Authorization for its coronavirus real-time PCR diagnostic test from the US Food and Drug Administration. The assay, called AvellinoCoV2 test, is designed for the detection of nuclei

On March 23, 2020, FDA announced that on March 18, FDA and the European Medicines Agency (EMA) co-chaired the first global regulators meeting to discuss regulatory strategies to streamline vaccine development for SARS-CoV-2, which causes th

NEW YORK The US Food and Drug Administration on Friday warned consumers to watch out for companies marketing unproven products for diagnosing, preventing, or treating COVID-19. We will continue to aggressively pursue those who place the pub

FDA has been working closely with other government agencies and academic centers that are investigating the use of the drug chloroquine to determine whether it can be used to treat patients with mild-to-moderate COVID-19 to potentially redu

FDA announced that the agency will temporarily postpone all domestic routine surveillance facility inspections, those conducted every few years based on a risk analysis. In a March 18, 2020 statement, FDA Commissioner Stephen M. Hahn said t

The FDA has cleared Drawbridge Health’s blood collection device designed to help monitor long-term blood sugar levels in people with diabetes, which the company describes as easier and less painful than a hypodermic needle.

Roche said recently that it has received US Food and Drug Administration 510(k) clearance for its Cobas TV/MG test for the detection of Trichomonas vaginalis (TV) and Mycoplasma genitalium (MG) DNA in symptomatic and asymptomatic patients.

A November 2018 FDA inspection has resulted in a warning letter for Zeller Power Products. The Wallace, ID-based company makes a replacement battery for Cardiac Science's PowerHeart Automated External Defibrillator (AED) G3.