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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FDA Coronavirus (COVID-19) Update: May 29th, 2020

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

FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 Coronavirus control measures.

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

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

The FDA and Federal Trade Commission (FTC) issued warning letters to two companies for selling fraudulent COVID-19 Coronavirus products, as part of the agency’s effort to protect consumers.

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