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  • FDA Coronavirus COVID-19 Update - - - FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



    FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


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

    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential
    ...
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  • U.S. Department of Education Releases - - - COVID-19 Handbook, Volume 2: Roadmap to Reopening Safely and Meeting All Students' Needs" - - -

    U.S. Department of Education Releases "COVID-19 Handbook, Volume 2: Roadmap to Reopening Safely and Meeting All Students' Needs" | site |



    (Information contained in U.S. Department Education press release dated: April 9, 2021)

    Today, the U.S. Department of Education (Department) released the COVID-19 Handbook, Volume 2: Roadmap to Reopening Safely and Meeting All Students' Needs to provide additional strategies for safely reopening all of America's schools and to promote educational equity by addressing opportunity gaps that have been exacerbated by the pandemic.

    Building off of Volume 1: Strategies for Safely Reopening Elementary and Secondary Schools, which focused on health and safety measures that schools can use to successfully implement the Centers for Disease Control and Prevention's (CDC) K-12 Operational Strategy, Volume 2 of the Handbook focuses on research-based strategies to address the social, emotional,
    ...
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  • CDC Awards 3 Billion Dollars to Expand COVID-19 Vaccine Programs

    CDC Awards 3 Billion Dollars to Expand COVID-19 Vaccine Programs

    Centers for Disease Control and Prevention Awards $3 Billion to Expand COVID-19 Vaccine Programs | site |



    CDC says Funding can be used for innovative partnerships with community-based organizations to increase vaccine uptake, including in underserved populations


    (Information contained in Centers for Disease Control and Prevention press release dated: April 6, 2021)

    The Centers for Disease Control and Prevention (CDC) has awarded funding to support local efforts to increase vaccine uptake by expanding COVID-19 vaccine programs and ensuring greater equity and access to vaccine by those disproportionately affected by SARS-CoV-2, the virus that causes COVID-19. The awards are part of $3 billion in funding that CDC has granted to 64 jurisdictions to bolster broad-based vaccine distribution, access, and administration efforts. The funding was made available by the American Rescue Plan and the Coronavirus Response an...
    See more | Go to post

  • 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

  • Biden Administration to Invest 250 Million Dollars in Effort to Encourage COVID-19 Safety and Vaccination Among Underserved Populations

    Biden Administration to Invest $250 Million in Effort to Encourage COVID-19 Safety and Vaccination Among Underserved Populations| site |



    HHS Office of Minority Health Will Offer Localities Funding to Partner with Community Organizations to Connect Minority, Underserved Populations with Vital Services, Promote Pandemic Safety Measures (Information contained in U.S. Department of Health and Human Services [HHS] press release dated: March 8, 2021) As part of President Biden's National Strategy for the COVID-19 Response and Pandemic Preparedness today, the Administration is announcing an effort to invest $250 million to encourage COVID-19 safety and vaccination among underserved populations. The U.S. Department of Health and Human Services (HHS) Office of Minority Health (OMH) will offer the funding as health literacy grants to localities, who will partner with community-based organizations, to reach racial and ethnic minority, rural and other vulnerable populati...
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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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  • Biden Administration Strengthens Requirements that Plans and Issuers Cover COVID-19 Diagnostic Testing Without Cost Sharing

    Biden Administration Strengthens Requirements that Plans and Issuers Cover COVID-19 Diagnostic Testing Without Cost Sharing and Ensures Providers are Reimbursed for Administering COVID-19 Vaccines to Uninsured | site |



    (Information contained in Centers for Medicare and Medicaid Services press release dated: February 26, 2021)

    In accordance with the Executive Order President Biden signed on January 21, 2021, the Centers for Medicare & Medicaid Services (CMS), together with the Department of Labor and the Department of the Treasury, (collectively, the Departments) issued new guidance today removing barriers to COVID-19 diagnostic testing and vaccinations and strengthening requirements that plans and issuers cover diagnostic testing without cost sharing. This guidance makes clear that private group health plans and issuers generally cannot use medical screening criteria to deny coverage for COVID-19 diagnostic tests for individuals with health cove
    ...
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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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  • U.S. Department of Homeland Security Secretary Mayorkas Visits FEMA COVID-19 Vaccination Facility in Philadelphia

    U.S. Department of Homeland Security Secretary Mayorkas Visits FEMA COVID-19 Vaccination Facility in Philadelphia | site |



    (Information contained in U.S. Department of Homeland Security [DHS] press release dated: March 2, 2021)

    Washington - - Today, Homeland Security Secretary Alejandro Mayorkas visited operations at the Federal Emergency Management Agency’s (FEMA) new Community Vaccination Center (CVC) facility at the Pennsylvania Convention Center in Philadelphia, scheduled to open tomorrow and expected to vaccinate up to 6,000 people per day. Secretary Mayorkas thanked and met with the Mayor of Philadelphia, Jim Kenney, and representatives from other partner organizations including the Pennsylvania Emergency Management Agency, Philadelphia Office of Emergency Management, Philadelphia Department of Public Health, and the Department of Defense. “On the first day of his administration, President Biden challenged FEMA to stand up 100 Federal...
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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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  • FEMA Supports Vaccine Distribution - - - COVID-19 Response Update

    FEMA Supports Vaccine Distribution - - - COVID-19 Response Update

    Federal Emergency Management Agency Supports Vaccine Distribution: COVID-19 Response Update | site |



    (Information contained in Federal Emergency Management Agency [FEMA] press release dated: March 2, 2021)


    Washington - - FEMA continues its push to speed up vaccinations across the country, supporting states as they open additional community vaccination centers this week. In addition to Pfizer and Moderna, the Johnson & Johnson vaccine will be delivered to three federal pilot community vaccination centers in California, Florida and Texas, helping to bring this unprecedented pandemic to an end. FEMA continues increasing vaccine allocations to states, tribes and territories, ensuring everyone who wants a vaccine can get one. Using data from CDC’s social vulnerability index, the agency is partnering with state leaders to identify community vaccination centers where they will be able to do the most good for the most vulnerable populations. Today, a comm...
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  • AFT says Nurses, Unions, Allies Urge CDC to Acknowledge Covid-19 Aerosol Transmission to Help Bring Virus Under Control

    American Federation of Teachers says Nurses, Unions, Allies Urge CDC to Acknowledge Covid-19 Aerosol Transmission to Help Bring Virus Under Control | site |




    AFT says "National Nurses United (NNU) and 44 allied unions and organizations, representing over 13 million members and their communities, are joining in coalition to urge the U.S. Centers for Disease Control and Prevention (CDC) to update its Covid-19 guidance to fully reflect the latest scientific evidence regarding SARS-CoV-2 transmission through aerosols that infected people emit when they breathe, speak, cough, sneeze, or sing."


    (Information contained in American Federation of Teachers [AFT] press release dated: February 23, 2021)

    Today, the undersigned unions and organizations delivered a petition with over 10,000 signatures, including scientific experts, urging the CDC to fully recognize Covid-19 aerosol transmission now. The Biden administration has made a
    ...
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  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Revokes Emergency Use Authorization for Monoclonal Antibody Bamlanivimab | site |



    FDA says "Alternative monoclonal antibody therapies authorized to treat patients with COVID-19 remain available"


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

    Today, the U.S. Food and Drug Administration revoked the emergency use authorization (EUA) that allowed for the investigational monoclonal antibody therapy bamlanivimab, when administered alone, to be used for the treatment of mild-to-moderate COVID-19 in adults and certain pediatric patients. Based on its ongoing analysis of emerging scientific data, specifically the sustained increase of SARS-CoV-2 viral variants that are resistant to bamlanivimab alone resulting in the increased risk for treatment failure, the FDA has determined that the known and potential
    ...
    04-18-2021, 04:36 AM
  • Staff Reporter 1
    U.S. Department of Education Releases - - - COVID-19 Handbook, Volume 2: Roadmap to Reopening Safely and Meeting All Students' Needs" - - -
    by Staff Reporter 1
    U.S. Department of Education Releases "COVID-19 Handbook, Volume 2: Roadmap to Reopening Safely and Meeting All Students' Needs" | site |



    (Information contained in U.S. Department Education press release dated: April 9, 2021)

    Today, the U.S. Department of Education (Department) released the COVID-19 Handbook, Volume 2: Roadmap to Reopening Safely and Meeting All Students' Needs to provide additional strategies for safely reopening all of America's schools and to promote educational equity by addressing opportunity gaps that have been exacerbated by the pandemic.

    Building off of Volume 1: Strategies for Safely Reopening Elementary and Secondary Schools, which focused on health and safety measures that schools can use to successfully implement the Centers for Disease Control and Prevention's (CDC) K-12 Operational Strategy, Volume 2 of the Handbook focuses on research-based strategies to address the social, emotional,
    ...
    04-13-2021, 10:02 PM
  • Staff Reporter 1
    CDC Awards 3 Billion Dollars to Expand COVID-19 Vaccine Programs
    by Staff Reporter 1
    Centers for Disease Control and Prevention Awards $3 Billion to Expand COVID-19 Vaccine Programs | site |



    CDC says Funding can be used for innovative partnerships with community-based organizations to increase vaccine uptake, including in underserved populations


    (Information contained in Centers for Disease Control and Prevention press release dated: April 6, 2021)

    The Centers for Disease Control and Prevention (CDC) has awarded funding to support local efforts to increase vaccine uptake by expanding COVID-19 vaccine programs and ensuring greater equity and access to vaccine by those disproportionately affected by SARS-CoV-2, the virus that causes COVID-19. The awards are part of $3 billion in funding that CDC has granted to 64 jurisdictions to bolster broad-based vaccine distribution, access, and administration efforts. The funding was made available by the American Rescue Plan and the Coronavirus Response an...
    04-09-2021, 06:13 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

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