FDA Coronavirus (COVID-19) Update: September 26th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

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FDA Coronavirus (COVID-19) Update: August 8th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration has taken the following actions in its ongoing response effort to the COVID-19 Coronavirus pandemic:

On August 6th, the FDA revoked the emergency use authorization (EUA) for Autobio Diagnostics Co., Ltd.’s, Anti-SARS-CoV-2 Rapid Test, a SARS-CoV-2 antibody test, due to performance concerns with the accuracy of the test.

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FDA Coronavirus (COVID-19) Update: August 4th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

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Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

Silver Spring, MD – The U.S. Food and Drug Administration (FDA) authorized the first two COVID-19 Coronavirus serology tests that display an estimated quantity of antibodies present in the individual’s blood.

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FDA Coronavirus (COVID-19) Update: June 17th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration is taking action in the ongoing response to the COVID-19 Coronavirus pandemic:

The FDA posted a new web page, Adverse Event Reporting for Medical Devices Under Emergency Use Authorization (EUA) or Discussed in COVID-19-Related Guidance Documents.

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Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study

Silver Spring, MD – The U.S. Food and Drug Administration publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI).

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FDA Coronavirus (COVID-19) Update: June 6th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration (FDA), Friday, May 5th, 2020, continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures and highlights of the agency’s response efforts.

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FDA Coronavirus (COVID-19) Update: June 5th, 2020

Silver Spring, MD – The U.S. Food and Drug Administration today continued to take action in the ongoing response to the COVID-19 pandemic:

Today, the FDA issued a new video resource explaining the different categories of tests in the fight against COVID-19 Coronavirus: diagnostic tests and antibody tests.

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