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  • U.S. Department of Labor sues New York Health Center and its CEO for Firing Employee who Reported Coronavirus Safety Concerns

    U.S. Department of Labor sues New York Health Center and its CEO for Firing Employee who Reported Coronavirus Safety Concerns | site |



    Alleges defendants violated Occupational Safety and Health Act anti-retaliation provisions


    (Information contained in U.S. Department of Labor press release dated: June 1, 2021) New York - - The U.S. Department of Labor is suing a Staten Island community health center and its CEO after they suspended and later fired an employee who reported coronavirus-related health and safety hazards, including possibly exposing staff to the virus and lack of proper social distancing protocols. The employee raised concern to company management that in-person attendance at a March 2020 staff meeting could lead to transmission and contraction of the virus. The worker attempted to reschedule the meeting by telephone, but ultimately refused to attend the meeting in-person after management refused the scheduling ...
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  • Treasury Launches Coronavirus State and Local Fiscal Recovery Funds to Deliver 350 Billion Dollars

    U.S. Department of the Treasury Launches Coronavirus State and Local Fiscal Recovery Funds to Deliver $350 Billion | site |


    Aid to state, local, territorial, and Tribal governments will help bring back jobs, address pandemic’s economic fallout, and lay the foundation for a strong, equitable recovery


    (Information contained in U.S. Department of the Treasury press release dated: May 10, 2021)

    Washington - - Today, the U.S. Department of the Treasury announced the launch of the Coronavirus State and Local Fiscal Recovery Funds, established by the American Rescue Plan Act of 2021, to provide $350 billion in emergency funding for state, local, territorial, and Tribal governments. Treasury also released details on the ways funds can be used to respond to acute pandemic-response needs, fill revenue shortfalls among state and local governments, and support the communities and populations hardest-hit by the COVID-19 crisis. Eligible state,...
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  • Coronavirus COVID-19 Update - - FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs

    Coronavirus (COVID-19) Update: FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 16, 2021)

    The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health

    March 16, 2021

    Statement From:

    Director - CDRH Offices: Office of the Center Director
    Dr. Jeffrey E. Shuren MD, JD Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomati
    ...
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  • Excerpt of FDA Coronavirus COVID-19 Update - - - March 12, 2021

    Excerpt of FDA Coronavirus COVID-19 Update - - - March 12, 2021

    Excerpt of U.S. Food and Drug Administration Coronavirus COVID-19 Update: March 12, 2021 | site |



    (Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: March 12, 2021)
    • Today, the FDA issued an Emergency Use Authorization (EUA) for Propofol-Lipuro 1% injectable emulsion for infusion to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency. Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved
    ...
    See more | Go to post

  • U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 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. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
    • On Friday the FDA issued
    ...
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  • Coronavirus COVID-19 Update - - - FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test

    Coronavirus (COVID-19) Update: FDA Authorizes Adaptive Biotechnologies T-Detect COVID Test | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the T-Detect COVID Test developed by Adaptive Biotechnologies. The T-Detect COVID Test is a next generation sequencing based (NGS) test to aid in identifying individuals with an adaptive T cell immune response to SARS-CoV-2, indicating recent or prior infection with SARS-CoV-2. “Today’s authorization further underscores the FDA’s commitment to innovation in test development,” said Jeff Shuren, M.D., J.D., director of FDA’s Center for Devices and Radiological Health. “The T-Detect COVID Test is a novel technology that assesses the T cell immune response to COVID-19. Information and scientific data that deepen our understandi...
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  • FDA Coronavirus COVID-19 Update - - - March 5, 2021

    FDA Coronavirus COVID-19 Update - - - March 5, 2021

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: March 5, 2021 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • The FDA sent letters to 25 firms that produce and issue “FDA registration certificates” to medical device companies (including manufacturers, distributors and sellers). In the letters, the FDA is requesting that firms cease producing and issuing such registration certificates. The registration certificates often have the look of an official government document and many display the FDA logo. The FDA does not issue any type of device establishment registration certificate. Registration and listing with FDA does not denote approval or clearance of the establishment or its devices. Some device manufacturers and distributors
    ...
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  • Coronavirus COVID-19 Update - - - FDA Issues Authorization for First Molecular Non-Prescription, At-Home Test

    Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Issues Authorization for First Molecular Non-Prescription, At-Home Test | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 5, 2021) Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Cue COVID-19 Test for Home and Over The Counter (OTC) Use. The product is a molecular nucleic acid amplification test (NAAT) that is intended to detect genetic material from SARS-CoV-2 virus present in the nostrils. The test is the first molecular test authorized for at-home use without a prescription. “The authorization of this new diagnostic test underscores FDA’s goal to continue supporting innovation in testing and providing flexibility to test developers with the aim of increasing the availability of accurate and reliable tests for all Americans,” said Acting FDA Commissioner Janet Woodcock, M.D. ...
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  • Coronavirus COVID-19 Update - - - March 2, 2021

    Coronavirus COVID-19 Update - - - March 2, 2021

    Coronavirus (COVID-19) Update: March 2, 2021 | site |



    (Information contained in U.S. Food and Drug Administration press release dated: March 2, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • The agency has updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures and highlights on the FDA's response efforts.
    • The agency issued an Emergency Use Authorization (EUA) to Quidel for its QuickVue At-Home COVID-19 Test for at-home use with a prescription. The Quidel QuickVue At-Home COVID-19 Test is an antigen test that detects proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample and gives a result in 10-15 minutes without needing to send a sample to a laboratory for analysis. The test is authorized for prescription at-home use with a self-collected nasal swab sample
    ...
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  • Coronavirus COVID-19 Update - - - FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test

    Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 1, 2021)


    Statement From:

    Director - CDRH Offices: Office of the Center Director
    Dr. Jeffrey E. Shuren MD, JD


    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis. The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healt...
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  • Coronavirus COVID-19 Update - - - FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

    Coronavirus (COVID-19) Update: U.S. Food and Drug Administration Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine | site |



    Update Provides Alternative Temperature for Transportation and Temporary Storage for Frozen Vials Before Dilution


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 25, 2021) Today, the U.S. Food and Drug Administration announced that it is allowing undiluted frozen vials of the Pfizer-BioNTech COVID-19 Vaccine to be transported and stored at conventional temperatures commonly found in pharmaceutical freezers for a period of up to two weeks. This reflects an alternative to the preferred storage of the undiluted vials in an ultra-low temperature freezer between -80ºC to -60ºC (-112ºF to -76ºF). The change is being reflected in updates to the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers)....
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  • Coronavirus (COVID-19) Update: February 23, 2021

    Coronavirus (COVID-19) Update: February 23, 2021

    Coronavirus (COVID-19) Update: February 23, 2021 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 23, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • Yesterday, the FDA issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19
    • The FDA issued a safety communication to inform patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy under certain circumstances. The Pulse Oximeter Accuracy and Limitations: FDA Safety Communication provides:
      • Important recommendations for patients and their caregivers on how to use pulse oximeters at home.
      • Recommendations for health
    ...
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  • Coronavirus COVID-19 Update - - - February 12, 2021

    Coronavirus COVID-19 Update - - - February 12, 2021

    Coronavirus COVID-19 Update - - - February 12, 2021 | site |




    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 12, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • This week, the FDA posted the webpage, COVID-19 Vaccine Safety Surveillance, which provides an overview of our active and passive systems used to monitor the safety of authorized COVID-19 vaccines. The FDA’s Center for Biologics Evaluation and Research is conducting these surveillance efforts in collaboration with the Centers for Disease Control and Prevention, the Center for Medicare and Medicaid Services, the Department of Veterans Affairs, and other academic and large non-government healthcare data systems.
    ...
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  • Coronavirus COVID-19 - - - FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19

    Coronavirus (COVID-19) Update: FDA Authorizes Monoclonal Antibodies for Treatment of COVID-19 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 9, 2021)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19 in adults and pediatric patients (12 years of age or older weighing at least 40 kilograms [about 88 pounds]) who test positive for SARS-CoV-2 and who are at high risk for progressing to severe COVID-19. The authorized use includes treatment for those who are 65 years of age or older or who have certain chronic medical conditions. In a clinical trial of patients with COVID-19 at high risk for disease progression, a single intravenous infusion of bamlanivimab and etesevimab administered together significantly reduced COVID-19-related hospitalization and death d
    ...
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  • Coronavirus COVID-19 Update - - - February 9, 2021

    Coronavirus COVID-19 Update - - - February 9, 2021

    Coronavirus (COVID-19) Update: February 9, 2021 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 9, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • Today, the FDA issued a Letter to Health Care Providers on Using Ventilator Splitters During the COVID-19 Pandemic to provide up-to-date information concerning multiplexing ventilator tubing connectors, also known as ventilator splitters, in situations in which no alternatives for invasive ventilatory support are available. The Letter to Health Care Providers also includes important information about ventilator splitters, including descriptions of features that may reduce certain risks associated with the use of ventilator splitters, considerations for health care providers and facilities when using ventilator splitters, and instructions for
    ...
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  • Staff Reporter 1
    U.S. Department of Labor sues New York Health Center and its CEO for Firing Employee who Reported Coronavirus Safety Concerns
    by Staff Reporter 1
    U.S. Department of Labor sues New York Health Center and its CEO for Firing Employee who Reported Coronavirus Safety Concerns | site |



    Alleges defendants violated Occupational Safety and Health Act anti-retaliation provisions


    (Information contained in U.S. Department of Labor press release dated: June 1, 2021) New York - - The U.S. Department of Labor is suing a Staten Island community health center and its CEO after they suspended and later fired an employee who reported coronavirus-related health and safety hazards, including possibly exposing staff to the virus and lack of proper social distancing protocols. The employee raised concern to company management that in-person attendance at a March 2020 staff meeting could lead to transmission and contraction of the virus. The worker attempted to reschedule the meeting by telephone, but ultimately refused to attend the meeting in-person after management refused the scheduling ...
    06-08-2021, 11:54 PM
  • Staff Reporter 1
    Treasury Launches Coronavirus State and Local Fiscal Recovery Funds to Deliver 350 Billion Dollars
    by Staff Reporter 1
    U.S. Department of the Treasury Launches Coronavirus State and Local Fiscal Recovery Funds to Deliver $350 Billion | site |


    Aid to state, local, territorial, and Tribal governments will help bring back jobs, address pandemic’s economic fallout, and lay the foundation for a strong, equitable recovery


    (Information contained in U.S. Department of the Treasury press release dated: May 10, 2021)

    Washington - - Today, the U.S. Department of the Treasury announced the launch of the Coronavirus State and Local Fiscal Recovery Funds, established by the American Rescue Plan Act of 2021, to provide $350 billion in emergency funding for state, local, territorial, and Tribal governments. Treasury also released details on the ways funds can be used to respond to acute pandemic-response needs, fill revenue shortfalls among state and local governments, and support the communities and populations hardest-hit by the COVID-19 crisis. Eligible state,...
    05-11-2021, 01:10 AM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: FDA takes Steps to Streamline Path for COVID-19 screening tools, provides Information to Help Groups establishing Testing Programs | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 16, 2021)

    The following is attributed to Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, and Tim Stenzel, M.D., Ph.D., director of the Office of In Vitro Diagnostics in the Center for Devices and Radiological Health

    March 16, 2021

    Statement From:

    Director - CDRH Offices: Office of the Center Director
    Dr. Jeffrey E. Shuren MD, JD Testing remains an important cornerstone of our nation’s fight against COVID-19. This includes schools, workplaces, communities and other locations using testing to screen asymptomatic individuals who may still spread the virus. Screening involves testing asymptomati
    ...
    03-23-2021, 12:14 AM
  • Staff Reporter 1
    Excerpt of FDA Coronavirus COVID-19 Update - - - March 12, 2021
    by Staff Reporter 1
    Excerpt of U.S. Food and Drug Administration Coronavirus COVID-19 Update: March 12, 2021 | site |



    (Excerpt of information contained in U.S. Food and Drug Administration [FDA] press release dated: March 12, 2021)
    • Today, the FDA issued an Emergency Use Authorization (EUA) for Propofol-Lipuro 1% injectable emulsion for infusion to maintain sedation via continuous infusion in patients greater than 16 years old who require mechanical ventilation in an intensive care unit setting during the COVID-19 public health emergency. Propofol-Lipuro 1% injectable emulsion for infusion is not FDA-approved and has important differences in its formulation compared to FDA-approved
    ...
    03-15-2021, 10:40 PM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update - - - March 9, 2021 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: March 9, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 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. The Cue COVID-19 Test for Home and Over The Counter (OTC) Use is a molecular test that can be used completely at home without a prescription by people with or without COVID-19 symptoms. It requires the use of a compatible smartphone and a downloadable app. The app provides testing instructions and works with the Cue Cartridge Reader (provided separately) and the Cue testing cartridge to perform the test. Results are available in about 20 minutes.
    • On Friday the FDA issued
    ...
    03-10-2021, 02:14 PM

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