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Topic: Emergency Use Authorization

FDA Coronavirus (COVID-19) Update: August 11th, 2020

 

U.S. Food and Drug Administration (FDA)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:

As part of the FDA’s effort to protect consumers, the agency issued a warning letter to one firm for selling unapproved products with fraudulent COVID-19 Coronavirus claims.

Coronavirus

Coronavirus

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

 

U.S. Food and Drug Administration (FDA)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.

Coronavirus.

Coronavirus.

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FDA Coronavirus (COVID-19) Update: August 7th, 2020

 

U.S. Food and Drug Administration (FDA)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.

Coronavirus

Coronavirus

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

 

U.S. Food and Drug Administration (FDA)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:

FDA has updated its COVID-19 Drug Shortages Response webpage to provide information regarding in-use time for certain drugs during the COVID-19 Coronavirus public health emergency.

Coronavirus

Coronavirus

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

 

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

Coronavirus.

Coronavirus.

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

 

U.S. Food and Drug Administration (FDA)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:

On July 24th, the FDA reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 Coronavirus symptoms or who have no reason to suspect COVID-19 Coronavirus infection, and to allow pooled sample testing.

Coronavirus

Coronavirus

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FDA Authorizes First Diagnostic Test for Screening of People Without Known or Suspected COVID-19 Infection

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) reissued the LabCorp COVID-19 RT-PCR Test emergency use authorization (EUA) to include two new indications for use: testing for people who do not have COVID-19 Coronavirus symptoms or who have no reason to suspect COVID-19 Coronavirus infection, and to allow pooled sample testing.

Coronavirus

Coronavirus

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

 

U.S. Food and Drug Administration (FDA)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:

FDA created a new website section about COVID-19 Coronavirus for people with cancer and health care professionals to highlight FDA resources and how FDA is working diligently to meet the needs of this vulnerable community during this critical time.

Coronavirus

Coronavirus

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

 

U.S. Food and Drug Administration (FDA)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

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

 

U.S. Food and Drug Administration (FDA)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:

The FDA reissued an Emergency Use Authorization (EUA) to Quest Diagnostics for its Quest SARS-CoV-2 rRT-PCR test, which is now authorized for use with pooled samples containing up to four individual upper-respiratory swab specimens collected under observation.

Coronavirus

Coronavirus

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