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FDA Approves Only Drug in the U.S. to Treat Severe Malaria: Artesunate

Treatment of severe malaria with intravenous (IV) artesunate should always be followed by a complete treatment course of an appropriate oral antimalarial regimen.

FDA Provides Promised Transparency for Antibody Tests

Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test's commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA.

FDA Collaborations Promote Rigorous Analyses of Real-World Data to Inform Pandemic Response

The FDA and Aetion aim to answer questions about the use of diagnostics and medications in the pandemic, and risk factors for COVID-19-related complications in different patient populations.

COVID-19 FDA Update

The FDA issued warning letters to two companies for selling fraudulent COVID-19 products, as part of the agency's effort to protect consumers. There are currently no FDA-approved products to prevent or treat COVID-19. Consumers concerned about COVID-19 should consult with their health care provider.

FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests

Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit.

FDA COVID-19 Update

The FDA issued an Emergency Use Authorization (EUA) for infusion pumps and infusion pump accessories that, among other things, meet certain safety, performance, and labeling criteria, in response to concerns relating to the insufficient supply and availability of the devices for use by healthcare providers in the continuous infusion of medications, total parenteral nutrition, and/or other fluids into patients during the COVID-19 pandemic.

FDA Coronavirus (COVID-19) Update

The FDA announced that the agency will host a virtual Town Hall on May 15, 2020, for researchers, clinical laboratories, and commercial manufacturers.

FDA Authorizes First Diagnostic Test Using At-Home Collection of Saliva Specimens

pecifically, the FDA issued an emergency use authorization (EUA) to Rutgers Clinical Genomics Laboratory for their COVID-19 laboratory-developed test (LDT), which had been previously added to the high complexity molecular-based LDT "umbrella" EUA, to permit testing of samples self-collected by patients at home using the Spectrum Solutions LLC SDNA-1000 Saliva Collection Device.