FDA updates EUA template for antigen test developers
The Food and Drug Administration yesterday released an updated template for developers requesting emergency use authorization for antigen tests for the COVID-19 virus. The template adds recommendations regarding studies for antigen tests to screen asymptomatic individuals or for SAR-CoV-2 and flu.
Related News Articles
Headline
The Department of Health of Human Services Aug. 21 issued a request for information seeking feedback on immunization categories within the Aug. 10 executive…
Headline
For the 2025-2026 school year, exemptions from one or more vaccines among U.S. kindergartners was at 4.2%, increasing from 3.6% for the previous school year,…
Headline
A study published Aug. 5 by Nature found that COVID-19 infection can reactivate dormant, chronic viruses such as Epstein-Barr and cytomegalovirus. The study…
Headline
The Food and Drug Administration Aug. 5 approved the first mRNA-based flu vaccine, called mFlusiva. The vaccine is manufactured by Moderna and was approved for…
Headline
The Department of Health and Human Services June 30 announced it will terminate emergency use authorization declarations for certain drugs and medical devices…
Headline
Centers for Medicare & Medicaid Services Administrator Mehmet Oz, M.D., and CMS Deputy Administrator and Director of Medicaid and CHIP Dan Brillman sat…