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 AHA provided recommendations to the Food and Drug Administration Dec. 1 in response to a request for information on the measurement and evaluation of…
Headline
The Food and Drug Administration has identified a Class I recall of Baxter Life2000 Ventilation Systems due to a cybersecurity issue discovered through…
Headline
A Washington resident recently hospitalized with the H5N5 strain of bird flu died Nov. 21, according to the Washington State Department of Health. The…
Headline
Flu cases are growing or likely growing in 39 states, according to the latest Centers for Disease Control and Prevention data from Nov. 11. COVID-19…
Headline
The Washington State Department of Health announced Nov. 14 that a state resident hospitalized earlier this month is the first human to have the H5N5 strain of…
Headline
The Food and Drug Administration yesterday published an announcement from Otsuka ICU Medical saying that the company issued a voluntary recall for a mislabeled…