Experts draw lessons from FDA's hydroxychloroquine EUA controversy September 8, 2020 -- Public health and regulatory experts advocated for changes to the U.S. Food and Drug Administration (FDA) emergency use authorization (EUA) process in a viewpoint published online August 31 in the Journal of the American Medical Association. They offer a set of recommendations to improve the process going forward as more COVID-19 vaccines and treatments emerge. Discuss
Detecting SARS-CoV-2 in blood may be early indicator of severe disease September 2, 2020 -- A blood test that measures SARS-CoV-2 RNA when patients are admitted to the hospital with COVID-19 symptoms can be a powerful diagnostic tool to predict how severe their disease will be, according to a study published in Clinical Infectious Diseases on August 28. Patients without viral RNA in their blood have a good chance at rapid recovery, concluded researchers from Karolinska Institutet and Danderyd Hospital. Discuss
Top 5 facts about the IVD market September 1, 2020 -- The market for IVD tests is vital and rapidly changing. IVD tests serve as a gateway to numerous other healthcare segments, and attract significant research and development spending and venture capital investments. Bruce Carlson of Kalorama Information explains the five facts that make the IVD market unique. Discuss
FDA authorizes Abbott's COVID-19 real-time antigen test August 27, 2020 -- The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization for a COVID-19 antigen test developed by Abbott Diagnostics Scarborough from which results can be read directly from the testing card.
HHS: FDA review not needed for coronavirus LDTs August 20, 2020 -- Laboratory-developed tests (LDTs) to diagnose whether patients are infected with the SARS-CoV-2 virus will not have to undergo review by the U.S. Food and Drug Administration (FDA), according to an August 19 guidance by the U.S. Department of Health and Human Services (HHS). Discuss