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Topic: U.S. Food and Drug Administration

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

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe 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.

Coronavirus.

Coronavirus.

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NASA selects Eight U.S. Manufacturers to make VITAL COVID-19 Ventilator

 

NASA - National Aeronautics and Space AdministrationPasadena, CA – After receiving more than 100 applications, NASA’s Jet Propulsion Laboratory in Southern California has selected eight U.S. manufacturers to make a new ventilator tailored for coronavirus (COVID-19) patients.

The prototype, which was created by JPL engineers in just 37 days, received an Emergency Use Authorization from the U.S. Food and Drug Administration on April 30th, 2020.

Prototypes of the VITAL ventilator, designed and tested NASA's Jet Propulsion Laboratory in just 37 days to address the needs of COVID-19 patients. (NASA/JPL-Caltech)

Prototypes of the VITAL ventilator, designed and tested NASA’s Jet Propulsion Laboratory in just 37 days to address the needs of COVID-19 patients. (NASA/JPL-Caltech)

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FDA Provides New Tool to Aid Development, Evaluation of Diagnostic Tests That Detect SARS-CoV-2 Infection

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) took a new step to support the agency’s evaluation of diagnostic tests for COVID-19 Coronavirus, by providing a SARS-CoV-2 reference panel. 

Reference panels are an additional step to ensure the quality of the tests, validation of new assays, test calibration, and monitoring of assay performance.

Coronavirus

Coronavirus

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

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

The FDA issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS).

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: May 28th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:

The FDA issued a guidance entitled “Reporting a Temporary Closure or Significantly Reduced Production by a Human Food Establishment and Requesting FDA Assistance During the COVID-19 Public Health Emergency.”

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: May 27th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration continues to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:

Coronavirus

Coronavirus

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Coronavirus (COVID-19) Update: FDA Provides Promised Transparency for Antibody Tests

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

Coronavirus.

Coronavirus.

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FDA Coronavirus (COVID-19) Update: May 23rd, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA) on Friday, May 22nd, 2020 continued to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:

Today, FDA and the U.S. Department of Agriculture released recommendations to help address shortages of personal protective equipment (PPE), cloth face coverings, disinfectants, and sanitation supplies in the food and agriculture industry during the COVID-19 Coronavirus pandemic. 

Coronavirus.

Coronavirus.

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FDA Coronavirus (COVID-19) Update: May 22nd, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:

Today, the FDA posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: May 21th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA) today continued to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:

The U.S. Department of Agriculture (USDA) and the FDA announced that the agencies signed a Memorandum of Understanding (MOU) to support the U.S. food and agriculture sector so that Americans can continue to have access to a safe and robust food supply.

Coronavirus

Coronavirus

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