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Topic: Stephen H. Hahn

FDA Issues Alert Regarding SARS-CoV-2 Viral Mutation

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) is alerting clinical laboratory staff and health care providers that the FDA is monitoring the potential impact of viral mutations, including an emerging variant from the United Kingdom known as the B.1.1.7 variant, on authorized SARS-CoV-2 molecular tests, and that false-negative results can occur with any molecular test for the detection of SARS-CoV-2 if a mutation occurs in the part of the virus’s genome assessed by that test.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has issued a new emergency use authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test which is authorized for use by patients at home with a prescription. 

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Issues Emergency Use Authorization for First COVID-19 Vaccine

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the United States.

FDA issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine.

FDA issues Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine.

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Lamar Alexander: FDA approved COVID-19 Vaccine is the way to stop more deaths

 

U.S. Senator Lamar Alexander

U.S. SenateWashington, D.C. – I chaired a hearing in the Senate health committee on Tuesday to explore the remarkable progression science is making toward a COVID-19 Coronavirus vaccine, as well as to remind parents to have their children get their childhood vaccinations and encourage as many Americans as possible to get the flu vaccine this fall.

I received an update on Operation Warp Speed, which is working around the clock to develop, manufacture, and distribute safe and effective COVID-19 Coronavirus vaccines as rapidly as possible.

U.S. Senator Lamar Alexander

U.S. Senator Lamar Alexander

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Coronavirus (COVID-19) Update: FDA Takes Action to Help Facilitate Timely Development of Safe, Effective COVID-19 Vaccines

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has taken important action to help facilitate the timely development of safe and effective vaccines to prevent COVID-19 Coronavirus by providing guidance with recommendations for those developing COVID-19 Coronavirus vaccines for the ultimate purpose of licensure.

Coronavirus.

Coronavirus.

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