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Topic: Silver Spring MD

FDA Authorizes Pfizer-BioNTech COVID-19 Vaccine for Emergency Use in Adolescents

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Today, May 10th, 2021,  the U.S. Food and Drug Administration (FDA) expanded the emergency use authorization (EUA) for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) to include adolescents 12 through 15 years of age.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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FDA Issues Procedural Notice on Potential Plans to Conduct Research About Use of ‘Healthy’ Symbols on Food Products

 

Conrad Choiniere, Ph.D.
Director of the Office of Analytics and Outreach, Center for Food Safety and Applied Nutrition

U.S. Food and Drug Administration (FDA)Silver Spring, MD – “The FDA understands that consumers want healthy choices when it comes to food and nutrition. Today, we are issuing a procedural notice on preliminary consumer research we are planning on the use of symbols on food product labels.

Nutrient content label.

Nutrient content label.

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FDA Coronavirus (COVID-19) Update: May 1st, 2021

 

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

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FDA Coronavirus (COVID-19) Update: April 25th, 2021

 

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

As part of the agency’s regulatory processes for reviewing all manufacturing facilities, the FDA recently completed an inspection of Emergent BioSolutions, a proposed manufacturing facility for the Johnson & Johnson COVID-19 Vaccine.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA, CDC Lift Recommended Pause on Johnson & Johnson (Janssen) COVID-19 Vaccine

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – Following a thorough safety review, including two meetings of the CDC’s Advisory Committee on Immunization Practices, the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention have determined that the recommended pause regarding the use of the Johnson & Johnson (Janssen) COVID-19 Coronavirus Vaccine in the U.S. should be lifted and use of the vaccine should resume.

COVID-19 Coronavirus Vaccine

COVID-19 Coronavirus Vaccine

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FDA Coronavirus (COVID-19) Update: Emergency Use Authorization issued for Symbiotica COVID-19 Self-Collected Antibody Test System

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced it has issued an emergency use authorization (EUA) for the Symbiotica COVID-19 Self-Collected Antibody Test System, the first antibody test authorized for use with home collected dried blood spot samples. Samples collected at home are then sent to a Symbiotica, Inc. laboratory for analysis.

COVID-19 Coronavirus

COVID-19 Coronavirus

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

 

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 issued a letter to health care personnel and facilities recommending transition from use of decontaminated disposable respirators.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: March 27th, 2021

 

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 March 23rd, 2021, the FDA issued an emergency use authorization (EUA) to the Twist Bioscience Corporation for their SARS-CoV-2 NGS Assay.

COVID-19 Coronavirus

COVID-19 Coronavirus

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FDA Coronavirus (COVID-19) Update: March 21th, 2021

 

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:

On March 16th, the FDA posted a new web page on FDA.gov, Screening for COVID-19: Deciding Which Test to Use When Establishing Testing Programs.

COVID-19 Coronavirus

COVID-19 Coronavirus

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

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) announced Tuesday, March 9th, 2021 that the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

On Friday, the FDA issued an Emergency Use Authorization (EUA) to Cue Health Inc. for its over-the-counter at-home diagnostic test for COVID-19.

COVID-19 Coronavirus

COVID-19 Coronavirus

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