Clarksville, TN Online: News, Opinion, Arts & Entertainment.


Topic: EUA

FDA Coronavirus (COVID-19) Update: January 10th, 2021

 

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

The FDA alerted clinical laboratory staff and health care providers that genetic variants of SARS-CoV-2 may lead to false-negative results with molecular tests for SARS-CoV-2. The Letter to Clinical Laboratory Staff and Health Care Providers includes important information about potential false-negative results with molecular tests.

COVID-19 Coronavirus

COVID-19 Coronavirus

«Read the rest of this article»

Sections: News | No Comments
 

FDA Coronavirus (COVID-19) Update: November 31st, 2020

 

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

The FDA published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 Coronavirus pandemic.

COVID-19 Coronavirus

COVID-19 Coronavirus

«Read the rest of this article»

Sections: News | No Comments
 

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

«Read the rest of this article»

Sections: News | No Comments
 


FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19 Coronavirus. The Ellume COVID-19 Home Test is a rapid, lateral flow antigen test, a type of test that runs a liquid sample along a surface with reactive molecules.

COVID-19 Coronavirus Test is authorized for individuals two years of age or older, including those not showing symptoms

COVID-19 Coronavirus Test is authorized for individuals two years of age or older, including those not showing symptoms

«Read the rest of this article»

Sections: News | No Comments
 

Tennessee receives first shipment of Pfizer COVID-19 Vaccination

 

Tennessee Department of HealthNashville, TN – The Tennessee Department of Health today, Monday, December 14th, 2020 announced the state has received its first shipment of the Pfizer-BioNTech COVID-19 vaccine ahead of statewide shipment on Thursday.

The state obtained an early shipment of 975 doses to hold as an emergency backup supply should any receiving hospital’s supply be damaged.

Pfizer COVID-19 Vaccine

Pfizer COVID-19 Vaccine

«Read the rest of this article»

Sections: News | No Comments
 

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.

«Read the rest of this article»

Sections: News | No Comments
 

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

COVID-19 Coronavirus

COVID-19 Coronavirus

«Read the rest of this article»

Sections: News | No Comments
 


FDA Statement on Vaccines, Related Biological Products Advisory Committee Meeting

 

The following is attributed to FDA Commissioner Stephen M. Hahn, M.D., and Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research.

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Following yesterday’s positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 Coronavirus vaccine, the U.S. Food and Drug Administration (FDA) has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization.

COVID-19 Coronavirus

COVID-19 Coronavirus

«Read the rest of this article»

Sections: News | No Comments
 

FDA Coronavirus (COVID-19) Update: November 25th, 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:

The FDA has published Face Masks, Including Surgical Masks, and Respirators for COVID-19 Coronavirus, a comprehensive new page on FDA.gov with answers to frequently asked questions about face masks, surgical masks, and respirators.

Coronavirus

Coronavirus

«Read the rest of this article»

Sections: News | No Comments
 

FDA Coronavirus (COVID-19) Update: November 24th, 2020

 

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

On November 20th, 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 provide skeletal muscle relaxation during surgery or mechanical ventilation.

Coronavirus

Coronavirus

«Read the rest of this article»

Sections: News | No Comments
 



  • Visit Us On FacebookVisit Us On TwitterVisit Us On PinterestVisit Us On YoutubeCheck Our FeedVisit Us On Instagram
  • Personal Controls