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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 15, 2021

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 15, 2021 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 15, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    ...
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  • Coronavirus COVID-19 Update - - - January 8, 2021

    Coronavirus COVID-19 Update - - - January 8, 2021

    Coronavirus (COVID-19) Update: January 8, 2021 | site |



    (The following is part of the information contained in U.S. Food and Drug Administration [FDA] press release: January 8, 2021)


    The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 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, including:
      • Details on the effect of genetic variants on test performance.
      • Recommendations for clinical laboratory staff and health care providers.
      • Actions the FDA has taken.
      • Instructions for reporting problems with a test.
    • This week, the FDA posted a new webpage, Moderna COVID-19 Vaccine Frequently
    ...
    See more | Go to post

  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - January 5, 2021

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



    (Information included in U.S. Food and Drug Administration [FDA] press release dated: January 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:
    • Today, the FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains.

    The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to:
    Expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA. Include
    ...
    See more | Go to post

  • U.S. Department of Labor publishes Guidance on Expiration of Paid Sick Leave

    U.S. Department of Labor publishes Guidance on Expiration of Paid Sick Leave

    U.S. Department of Labor publishes Guidance on Expiration of Paid Sick Leave and Expanded Family and Medical Leave for Coronavirus | site |




    (Information contained in U.S. Department of Labor press release dated: December 31, 2020)

    Washington, DC - - The U.S. Department of Labor’s Wage and Hour Division (WHD) today announced additional guidance to provide information to workers and employers about protections and relief offered by the Families First Coronavirus Response Act (FFCRA). The FFCRA’s paid sick leave and expanded family and medical leave requirements will expire on Dec. 31, 2020.

    The new guidance, in the form of Frequently Asked Questions on the WHD website, addresses whether workers who did not use their leave entitlement under the FFCRA in 2020 may use such leave after Dec. 31, 2020. It also explains how WHD will maintain its enforcement authority over employers’ leave responsibilities while the FFCRA’s paid leave
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 30, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 30, 2020 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 30, 2020)

    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 published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. Furthermore, a new COVID-19 Communication Toolkits webpage provides links to all FDA toolkits on COVID-19 topics to help everyone communicate accurate and timely information to patients, the public, and health care professionals.
    ...
    See more | Go to post

  • FDA Coronavirus COVID-19 Update - - - December 28, 2020

    FDA Coronavirus COVID-19 Update - - - December 28, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 28, 2020 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 28, 2020)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    • On Dec. 23, the FDA updated the Device Shortage List on our web page that lists Medical Device Shortages During the COVID-19 Public Health Emergency. Specifically, the FDA added the following device types in the testing supplies and equipment category: pipette tips (product codes LXG and PPM) and micro pipettes (product code JRC). The FDA also added clarifying notes and links to more resources in the “Additional Information” column, as well as adding clarity to the categories, such as grouping gloves under “Personal Protective Equipment – Gloves.” The device shortage list reflects the categories of
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 22, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 22, 2020 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 22, 2020)

    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 has posted translations of the Moderna COVID-19 Vaccine fact sheet for recipients and caregivers, and the fact sheet for healthcare providers in languages including: Arabic, Chinese, French, Spanish, Tagalog, and Vietnamese. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
    • The FDA recently approved three abbreviated new drug applications (ANDAs):
    On Dec. 18, one ANDA for etomidate injection, indicated for the induction of general anesthesia. The most common side effects of etomidate injection are venous pain on injection and
    ...
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  • Statement by Secretary Steven T. Mnuchin on Passage of the Coronavirus Response and Relief Supplemental Appropriations Act

    Statement by U.S. Treasury Secretary Steven T. Mnuchin on Passage of the Coronavirus Response and Relief Supplemental Appropriations Act | site |


    (Information contained in U.S. Department of the Treasury press release statement: December 22, 2020)



    Statement by Secretary Steven T. Mnuchin on Passage of the Coronavirus Response and Relief Supplemental Appropriations Act

    Washington - - Secretary Steven T. Mnuchin issued the following statement on passage of the Coronavirus Response and Relief Supplemental Appropriations Act as part of the Consolidated Appropriations Act of 2021: “I am pleased that the United States Senate and House of Representatives have passed on an overwhelmingly bipartisan basis the Coronavirus Response and Relief Supplemental Appropriations Act, as part of the Consolidated Appropriations Act of 2021. I want to thank President Trump for his leadership and Leader McConnell, Leader Schumer, Speaker Pel...
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  • FDA Coronavirus (COVID-19) Update - - - December 21, 2020

    FDA Coronavirus (COVID-19) Update - - - December 21, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 21, 2020 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 21, 2020)

    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 has posted translations of the Pfizer-BioNTech COVID-19 Vaccine fact sheet for recipients and caregivers in languages including: Arabic, Burmese, Cherokee, Chinese (Simplified and Traditional), Chuukese, German, Haitian Creole, Hindi, Hmong, Korean, Mam, Polish, Portuguese, Russian, Spanish, Somali, Tagalog, Vietnamese, and Yiddish. We will post additional language translations of the fact sheet for recipients and caregivers to this page as we receive the translations.
    • Today, the agency updated its FDA COVID-19 Response At-A-Glance Summary, which provides a quick look at facts, figures, and highlights on
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 17, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 17, 2020| site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 17, 2020)

    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’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), made up of independent scientific and public health experts from around the country, met to discuss a request for emergency use authorization (EUA) for a vaccine for COVID-19 prevention, submitted by ModernaTX, Inc. This meeting is an important step in the review process, providing an opportunity for outside experts to provide valuable advice and input for the agency to consider as part of its review. Importantly, the final decision about whether to authorize the vaccine for emergency use will be made by FDA’s career officials.
    • Also
    ...
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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 16, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 16, 2020 | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: December 16, 2020)

    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 new Emergency Use Authorization (EUA) for the BinaxNOW COVID-19 Ag Card Home Test for at-home use with a prescription. The BinaxNOW COVID-19 Ag Card Home Test is an antigen test that detects fragments of proteins from SARS-CoV-2, the virus that causes COVID-19, from a nasal swab sample. It is authorized for use at home with self-collected samples in individuals age 15 years or older who are suspected of having COVID-19 by a health care provider within the first seven days of symptom onset. The test is also for use with individuals aged four years or older who
    ...
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  • NIH Observational Study of Coronavirus Infection and Multisystem Inflammatory Syndrome in Children Begins

    National Institutes of Health Observational Study of Coronavirus Infection and Multisystem Inflammatory Syndrome in Children Begins | site |



    (Information contained in National Institutes of Health [NIH] press release: December 16, 2020) An observational study has launched to evaluate the short- and long-term health outcomes of SARS-CoV-2 infection in children, including multisystem inflammatory syndrome in children (MIS-C), and to characterize the immunologic pathways associated with different disease presentations and outcomes. SARS-CoV-2 is the virus that causes COVID-19. The study, called the Pediatric Research Immune Network on SARS-CoV-2 and MIS-C (PRISM), will enroll at least 250 children and young adults ages 20 years or younger from diverse racial and ethnic backgrounds at approximately 20 sites nationwide. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is sponsoring and funding the study. ...
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  • FDA Coronavirus COVID-19 Update - - - FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 16, 2020) Today, the U.S. Food and Drug Administration 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. The BinaxNOW COVID-19 Ag Card Home Test is authorized for prescription use at home with self-collected nasal swab samples from individuals ages 15 years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. It is also authorized for use with adult-collected nasal swab samples from individuals ages four years or older who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset. The test will b...
    See more | Go to post

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

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: FDA Authorizes Antigen Test as First Over-the-Counter Fully At-Home Diagnostic Test for COVID-19 | site |


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


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 15, 2020)

    Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the first over-the-counter (OTC) fully at-home diagnostic test for COVID-19. 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. The test detects fragments of proteins of the SARS-CoV-2 virus from a nasal swab sample from any individual 2 years of age or older. “Today’s authorization is a major milestone in diagnostic testing for COVID-19. By authorizing a test for over- the-c
    ...
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  • Excerpt from FDA Coronavirus COVID-19 Update - - - December 14, 2020

    Excerpt from FDA Coronavirus COVID-19 Update - - - December 14, 2020

    Excerpts from U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 14, 2020 | site |




    (The following are EXCERPTS from information contained in a U.S. Food and Drug Administration [FDA] press release: December 14, 2020)

    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 posted the review memorandum outlining the basis of the agency’s decision to authorize the Pfizer-BioNTech COVID-19 Vaccine. To ensure all Americans can have trust and confidence in the carefulness of FDA’s review, we have made, and will continue to make, the vaccine review process as transparent as possible.
    • On Dec. 11, the agency approved an abbreviated new drug application for midazolam injection, indicated for preoperative sedation/anxiolysis (anxiety)/amnesia; as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic
    ...
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  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - January 15, 2021
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 15, 2021 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: January 15, 2021)

    The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:
    ...
    01-17-2021, 05:15 AM
  • Staff Reporter 1
    Coronavirus COVID-19 Update - - - January 8, 2021
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: January 8, 2021 | site |



    (The following is part of the information contained in U.S. Food and Drug Administration [FDA] press release: January 8, 2021)


    The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 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, including:
      • Details on the effect of genetic variants on test performance.
      • Recommendations for clinical laboratory staff and health care providers.
      • Actions the FDA has taken.
      • Instructions for reporting problems with a test.
    • This week, the FDA posted a new webpage, Moderna COVID-19 Vaccine Frequently
    ...
    01-09-2021, 05:39 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - January 5, 2021
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: January 5, 2021 | site |



    (Information included in U.S. Food and Drug Administration [FDA] press release dated: January 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:
    • Today, the FDA posted a new webpage on the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) highlighting authorities that are intended to enhance the FDA’s ability to identify, prevent, and mitigate possible drug shortages by, among other things, enhancing the FDA’s visibility into drug supply chains.

    The CARES Act amended the Federal Food, Drug, and Cosmetic (FD&C) Act to:
    Expand the requirement for manufacturers of certain drugs to provide information on permanent discontinuances and interruptions in manufacturing that may lead to a meaningful disruption in supply to the FDA. Include
    ...
    01-06-2021, 02:05 AM
  • Staff Reporter 1
    U.S. Department of Labor publishes Guidance on Expiration of Paid Sick Leave
    by Staff Reporter 1
    U.S. Department of Labor publishes Guidance on Expiration of Paid Sick Leave and Expanded Family and Medical Leave for Coronavirus | site |




    (Information contained in U.S. Department of Labor press release dated: December 31, 2020)

    Washington, DC - - The U.S. Department of Labor’s Wage and Hour Division (WHD) today announced additional guidance to provide information to workers and employers about protections and relief offered by the Families First Coronavirus Response Act (FFCRA). The FFCRA’s paid sick leave and expanded family and medical leave requirements will expire on Dec. 31, 2020.

    The new guidance, in the form of Frequently Asked Questions on the WHD website, addresses whether workers who did not use their leave entitlement under the FFCRA in 2020 may use such leave after Dec. 31, 2020. It also explains how WHD will maintain its enforcement authority over employers’ leave responsibilities while the FFCRA’s paid leave
    ...
    01-02-2021, 07:50 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - - December 30, 2020
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: December 30, 2020 | site |



    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 30, 2020)

    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 published a new toolkit to help stakeholders communicate in English and Spanish about hand sanitizer safety and use during the COVID-19 pandemic. New materials include social media messages and graphics, consumer information, and health professional messaging. Furthermore, a new COVID-19 Communication Toolkits webpage provides links to all FDA toolkits on COVID-19 topics to help everyone communicate accurate and timely information to patients, the public, and health care professionals.
    ...
    12-31-2020, 06:26 AM

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