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Topic: FDA

Coronavirus (COVID-19) Update: FDA Publicly Shares Antibody Test Performance Data From Kits as Part of Validation Study

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration publicly posted test performance data from four more antibody, or serology, test kits on open.fda.gov from its independent performance validation study effort with the National Institutes of Health’s (NIH) National Cancer Institute (NCI).

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: June 6th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA), Friday, May 5th, 2020, continued to take action in the ongoing response to the COVID-19 Coronavirus pandemic:

The FDA issued an updated FDA COVID-19 Response At-A-Glance Summary that provides a quick look at facts, figures and highlights of the agency’s response efforts.

Coronavirus.

Coronavirus.

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Developing a COVID-19 Vaccine Quickly Proving to be a Daunting Task But Progress Still Expected

 

U.S. Food and Drug Administration (FDA)Palm Beach, FL – Rapid development of a vaccine to prevent the global health crisis is a global imperative, and defining the stakes and potential hurdles is critical because regulatory and medical decisions are based on benefit/risk calculations.

The benefit of developing an effective vaccine is very high, and even greater if it can be deployed in time to prevent repeated or continuous epidemics.

Coronavirus

Coronavirus

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

 

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

Today, the FDA issued a new video resource explaining the different categories of tests in the fight against COVID-19 Coronavirus: diagnostic tests and antibody tests.

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FDA Coronavirus (COVID-19) Update: June 4th, 2020

 

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

The FDA announced a new web-based resource, titled Testing Supply Substitution Strategies.

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: June 3rd, 2020

 

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

The agency issued a new FDA Voices, titled Pandemic Challenges Highlight the Importance of the New Era of Smarter Food Safety, and bylined by Stephen M. Hahn, M.D., Commissioner of Food and Drugs, and Frank Yiannas, Deputy Commissioner for Food Policy and Response.

Coronavirus

Coronavirus

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FDA Coronavirus (COVID-19) Update: June 2nd, 2020

 

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

On May 29th, the FDA issued a new FDA Voices, Bringing a Cancer Doctor’s Perspective to FDA’s Response to the COVID-19 Coronavirus Pandemic.

Coronavirus.

Coronavirus.

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FDA Approves First Drug to Image Tau Pathology in Patients Being Evaluated for Alzheimer’s Disease

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration has approved Tauvid (flortaucipir F18) for intravenous injection, the first drug used to help image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology.

Tauvid is a radioactive diagnostic agent for adult patients with cognitive impairment who are being evaluated for Alzheimer’s disease.

Approval Marks Significant Advance Towards a More Definitive Assessment of Alzheimer's Based on Brain Imaging

Approval Marks Significant Advance Towards a More Definitive Assessment of Alzheimer’s Based on Brain Imaging

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Coronavirus (COVID-19) Update: FDA Takes Steps to Streamline Development of Tests With At-Home Sample Collection

 

U.S. Food and Drug Administration (FDA)Silver Spring, MDThe U.S. Food and Drug Administration (FDA) took steps on Friday, May 29th, 2020, to further support the development of COVID-19 Coronavirus tests for at-home self-collection by including a voluntary EUA template for at-home sample collection kits to its website.

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

 

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

FDA is making its previously developed FDA MyStudies app available to investigators as a free platform to securely obtain patients’ informed consent for eligible clinical trials when face-to-face contact is not possible or practical due to COVID-19 Coronavirus control measures.

Coronavirus.

Coronavirus.

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