FDA Coronavirus (COVID-19) Update: July 22nd, 2020
July 22, 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:
A new FDA Voices, tilted FDA’s Ongoing Work to Support and Advance COVID-19 Diagnostic Test Accuracy and Availability, describes how FDA has been proactive and supportive of test development by all comers — including laboratories, and large and small commercial manufacturers — to speed development and to quickly authorize tests that the science supports.
Coronavirus
Coronavirus (COVID-19) Update: FDA Issued Emergency Use Authorization for Point of Care Antigen Test
July 12, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for a COVID-19 Coronavirus antigen diagnostic test, the BD (Becton Dickinson) Veritor System for Rapid Detection of SARS-CoV-2.
Coronavirus
Coronavirus (COVID-19) Update: Facilitating Diagnostic Test Availability for Asymptomatic Testing and Sample Pooling
June 21, 2020
Silver Spring, MD – Diagnostic tests are an important tool in anticipating and meeting the continuing and evolving public health needs as we combat COVID-19 Coronavirus.
Coronavirus
FDA Coronavirus (COVID-19) Update: June 18th, 2020
June 18, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) continues to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
On June 16th, 2020, the FDA approved an abbreviated new drug application for succinylcholine chloride injection USP 200 mg/10 mL, which is indicated, in addition to general anesthesia, to facilitate tracheal intubation and to induce skeletal muscle relaxation during surgery or mechanical ventilation.
Coronavirus
Coronavirus (COVID-19) Update: FDA Authorizes First Next Generation Sequence Test for Diagnosing COVID-19
June 14, 2020
Silver Spring, MD – The U.S. Food and Drug Administration issued an emergency use authorization (EUA) to Illumina, Inc. for the first COVID-19 Coronavirus diagnostic test utilizing next generation sequence technology.
Coronavirus
FDA Coronavirus (COVID-19) Update: June 13th, 2020
June 13, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) is continuing to take action in the ongoing response to the COVID-19 Coronavirus pandemic:
This week, the FDA issued an Emergency Use Authorization (EUA) for Cue Health Inc.’s Cue COVID-19 Coronavirus Test.
Coronavirus
Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection
May 31, 2020
Silver Spring, MD – The U.S. Food and Drug Administration (FDA) took steps on Friday, May 29th, 2020, to further support the development of COVID-19 Coronavirus tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.
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.
Coronavirus
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
