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Topic: FDA

Coronavirus (COVID-19) Update: FDA Authorizes First Tests that Estimate a Patient’s Antibodies from Past SARS-CoV-2 Infection

 

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

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: August 1st, 2020

 

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

As part of the FDA’s effort to protect consumers, the agency issued a warning letter jointly with the Federal Trade Commission to one company for selling fraudulent COVID-19 Coronavirus related products.

Coronavirus

Coronavirus

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President Donald Trump and His Administration have created Best COVID-19 Testing System In The World

 

Leading the World in Testing

The White HouseWashington, D.C. – U.S. President Donald J. Trump is ensuring that Americans have access to the most advanced and robust COVID-19 Coronavirus tests in the world.

President Trump has revolutionized America’s testing system, and under his leadership, our Nation has conducted far more tests than any other country.

The United States has already conducted more than 59 million tests, and we will soon have conducted 100 million tests.

U.S. President Donald J. Trump

U.S. President Donald J. Trump

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FDA Coronavirus (COVID-19) Update: July 30th, 2020

 

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

On July 29th, FDA updated its “Food Safety and the Coronavirus Disease” webpage of Questions and Answers (Q&A).

Coronavirus

Coronavirus

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FDA Warns Companies Illegally Selling Hangover Remedies

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Today, Thursday, July 30th, 2020, the U.S. Food and Drug Administration announced it has issued warning letters to seven companies for illegally selling unapproved products labeled as dietary supplements that claim to cure, treat, mitigate or prevent hangovers, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act).

FDA cracks down on Companies selling Illegal Hangover Remedies.

FDA cracks down on Companies selling Illegal Hangover Remedies.

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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) has taken action in the ongoing response to the COVID-19 Coronavirus pandemic:

On July 28th, the FDA updated the Molecular Diagnostic templates.

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 Requiring Labeling Changes for Opioid Pain Medicines, Opioid Use Disorder Medicines Regarding Naloxone

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration has announced it is requiring that labeling for opioid pain medicine and medicine to treat opioid use disorder (OUD) be updated to recommend that as a routine part of prescribing these medicines, health care professionals should discuss the availability of naloxone with patients and caregivers, both when beginning and renewing treatment.

Goal is to Help Reduce Opioid Overdoses and Deaths

Goal is to Help Reduce Opioid Overdoses and Deaths

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