FDA Coronavirus (COVID-19) Update: May 27th, 2020
May 27, 2020
Silver Spring, MD – The U.S. Food and Drug Administration continues to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:
Coronavirus
FDA Coronavirus (COVID-19) Update: May 23rd, 2020
May 23, 2020
Silver Spring, MD – The 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.
FDA Coronavirus (COVID-19) Update: May 22nd, 2020
May 22, 2020
Silver Spring, MD – The 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
FDA Coronavirus (COVID-19) Update: May 21th, 2020
May 21, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (DDA) 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
FDA Coronavirus (COVID-19) Update: May 19th, 2020
May 19, 2020
Silver Spring, MD – The 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 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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FDA Authorizes First Standalone At-Home Sample Collection Kit That Can Be Used With Certain Authorized Tests
May 17, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has authorized an at-home sample collection kit that can then be sent to specified laboratories for COVID-19 Coronavirus diagnostic testing.
Specifically, the FDA issued an emergency use authorization (EUA) to Everlywell, Inc. for the Everlywell COVID-19 Test Home Collection Kit.
Coronavirus
FDA Coronavirus (COVID-19) Update: May 15th, 2020
May 15, 2020
Silver Spring, MD – The 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 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.
Coronavirus
FDA Coronavirus (COVID-19) Update: May 13th, 2020
May 13, 2020
Silver Spring, MD – The 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 took important actions to help accelerate the development of prevention and treatment options for COVID-19 Coronavirus by providing new guidance with recommendations for innovators and researchers conducting work in this area.
Coronavirus
FDA Coronavirus (COVID-19) Update: May 12th, 2020
May 12, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continues to take action in the ongoing response effort to the COVID-19 Coronavirus pandemic:
The FDA issued an Emergency Use Authorization (EUA) for emergency use of the Fresenius Propoven 2% Emulsion to maintain sedation via continuous infusion in patients older than 16 who require mechanical ventilation in an ICU during the COVID-19 Coronavirus public health emergency.
Coronavirus
Coronavirus (COVID-19) Update: FDA Authorizes First Antigen Test to Help in the Rapid Detection of the Virus that Causes COVID-19 in Patients
May 10, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has issued the first emergency use authorization (EUA) for a COVID-19 antigen test, a new category of tests for use in the ongoing pandemic. These diagnostic tests quickly detect fragments of proteins found on or within the virus by testing samples collected from the nasal cavity using swabs.
Coronavirus
