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  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup September 18, 2020

    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup September 18, 2020 | site |



    (September 18, 2020) - - Today, September 18, 2020, the U.S. Food and Drug Administration published the following information:

    The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
    • The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to:
      • Indicate that testing is for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.”
      • Clarify that testing is authorized for laboratories certified under CLIA and meet the requirements to perform high, moderate, or waived complexity tests.
      • Clarify that testing facilities within the United States and its territories
    ...
    See more | Go to post

  • U.S. Department of Housing and Urban Development provides 100 Million Dollars in CARES ACT Funding to Native American Tribes to support Coronavirus Recovery Efforts

    U.S. Department of Housing and Urban Development provides $100 Million in CARES ACT Funding to Native American Tribes to support Coronavirus Recovery Efforts | site |



    (August 31, 2020) - - The U.S. Department of Housing and Urban Development published (today) the following information:

    WASHINGTON - Today, the U.S. Department of Housing and Urban Development (HUD) Secretary Ben Carson announced that HUD has awarded a total of $100 million to Tribes across the Nation as part of HUD’s Indian Community Development Block Grant Imminent Threat program (ICDBG-CARES). This funding helps address problems that pose an imminent threat to public health or safety of Tribal residents and will be used to help Tribes prevent, prepare for, and respond to COVID-19. See list of funding here.

    “The Trump Administration is committed to helping families throughout Indian Country to access essential resources during the coronavirus outbreak,” said Secretary
    ...
    See more | Go to post

  • U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup May 28, 2020

    Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020| site |



    (May 28, 2020) - - Today (May 28, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    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 issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. N95 respirators containing cellulose-based materials
    ...
    See more | Go to post

  • Centers for Disease Control and Prevention says United States Coronavirus Death Toll Surpasses 100,000

    Centers for Disease Control and Prevention says United States Coronavirus (COVID-19) Death Toll Surpasses 100,000 | site |


    May 28, 2020) - - Today, the Centers for Disease Control and Prevention (CDC) published the following information: Today the number of people in the United States who have died from COVID-19 surpassed 100,000. Families, friends, coworkers, loved ones and community members are grieving for each person who has been lost to this disease. Reaching the milestone of 100, 000 persons lost in such a short timeframe is a sobering development and a heart-breaking reminder of the horrible toll of this unprecedented pandemic. COVID-19 has touched families in every part of America – with communities across the country experiencing the pandemic in different ways. As many communities are strategically reopening, it is important for everyone to work together to continue efforts to prevent community spread of COVID-19. We ask that all Americans continue to follow t...
    See more | Go to post

  • U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests

    U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests| site |



    (May 21, 2020) - - The U.S. Food and Drug Administration (FDA) published today (May 21, 2020) the following information:

    Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on
    ...
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  • U.S. Department of Labor Adopts Revised Enforcement Policies for Coronavirus

    U.S. Department of Labor Adopts Revised Enforcement Policies for Coronavirus

    U.S. Department of Labor Adopts Revised Enforcement Policies for Coronavirus| site |



    (May 19, 2020) - - Today (May 19, 2020) the U.S. Department of Labor published the following information: WASHINGTON, DC – The U.S. Department of Labor's Occupational Safety and Health Administration (OSHA) has adopted revised policies for enforcing OSHA's requirements with respect to coronavirus as economies reopen in states throughout the country. Throughout the course of the pandemic, understanding about the transmission and prevention of infection has improved. The government and the private sector have taken rapid and evolving measures to slow the virus's spread, protect employees, and adapt to new ways of doing business. Now, as states begin reopening their economies, OSHA has issued two revised enforcement policies to ensure employers are taking action to protect their employees. First, OSHA is increasing in-person inspections at all types of workplaces. The ...
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  • Newsweek Article suggests that Coronavirus COVID-19 may have been Created with aid of U.S. Dollars

    Newsweek Article suggests that Coronavirus COVID-19 may have been Created with aid of U.S. Dollars | site |



    Article says China lab received millions of U.S. Dollars for bat disease research


    April 30, 2020 - - The publication Newsweek suggested in an April 28, 2020 article that the Coronavirus COVID-19 may have been created in a China lab in which the research was partially funded by millions of U.S. Dollars.

    The article, titled, "Dr. Fauci Backed Controversial Wuhan Lab with Millions of U.S. Dollars" is located online at https://www.newsweek.com/dr-fauci-ba...search-1500741

    or

    Please press HERE
    ...
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  • U.S. Securities and Exchange Commission Provides Temporary Additional Flexibility to Registered Investment Companies Affected by Coronavirus

    U.S. Securities and Exchange Commission Provides Temporary Additional Flexibility to Registered Investment Companies Affected by Coronavirus | site |


    Permits Funds to Use Additional Funding and Other Tools to Manage their Portfolios for the Benefit of Investors



    (March 23, 2020) - - Today (March 23, 2020), the U.S. Securities and Exchange Commission (SEC) published the following information: Washington D.C., March 23, 2020 —The Securities and Exchange Commission today announced temporary flexibility for registered funds affected by recent market events to borrow funds from certain affiliates and to enter into certain other lending arrangements. Today’s relief is designed to provide funds with additional tools to manage their portfolios for the benefit of all shareholders as investors may seek to rebalance their investments. “Today’s temporary action will provide an additional tool that funds can use to manage their portfolios for the bene...
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  • Coronavirus COVID-19 Update - - - FDA provides Update on Patient Access to certain REMS Drugs during COVID-19 Public Health Emergency

    Coronavirus COVID-19 Update - - - FDA provides Update on Patient Access to certain REMS Drugs during COVID-19 Public Health Emergency | site |




    (March 22, 2020) - - The U.S. Food and Drug Administration (FDA) published today (March 22, 2020) the following information:

    Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus pandemic (COVID-19), the agency issued a new guidance to sponsors and healthcare providers regarding certain Risk Evaluation and Mitigation Strategy (REMS)-required testing during this time.

    “The FDA recognizes that during the COVID-19 public health emergency, the completion of some REMS-required laboratory testing or imaging studies may be difficult because patients suspected of having COVID-19 may be self-isolating and/or subject to quarantine,” said FDA Principal Deputy Commissioner Amy Abernethy, M.D., Ph.D. “Under these circumstances, undergoing
    ...
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  • Coronavirus COVID-19 Update - - - FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators

    Coronavirus COVID-19 Update - - - FDA Continues to Facilitate Access to Crucial Medical Products, Including Ventilators | site |




    (March 22, 2020) - - The U.S. Food and Drug Administration (FDA) published today (March 22, 2020) the following information:

    Today, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing. “The FDA’s new actions will mean America can make more ventilators during this crisis,” said Health and Human Services Secretary Alex Azar. “Today’s actions are another step by the FDA and HHS to eliminate every possible barrier to the all-of-America approach that President Trump has called for. With this boost from the FDA, medical device makers can more easily make changes to existing products, such as changes
    ...
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  • Coronavirus COVID-19 Update - - - FDA Issues first Emergency Use Authorization for Point of Care Diagnostic

    Coronavirus COVID-19 Update - - - FDA Issues first Emergency Use Authorization for Point of Care Diagnostic | site |




    (March 21, 2020) - - The U.S. Food and Drug Administration published today (March 21, 2020) the following information:

    Today, the U.S. Food and Drug Administration issued the first emergency use authorization for a point-of-care COVID-19 diagnostic for the Cepheid Xpert Xpress SARS-CoV-2 test. “The test we’re authorizing today will be able to provide Americans with results within hours, rather than days like the existing tests, and the company plans to roll it out by March 30, which is an incredibly rapid timeline for such an effort. With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them,” said HHS Secretary Alex Azar. “With the development of point of care diagnostics, Americans who need tests will be able to
    ...
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  • Coronavirus COVID-19 Update - - - FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits

    Coronavirus COVID-19 Update - - - FDA Alerts Consumers About Unauthorized Fraudulent COVID-19 Test Kits | site |



    Statement From:

    Commissioner of Food and Drugs - Food and Drug Administration
    Stephen M. Hahn M.D.
    Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs
    Judith A. McMeekin Pharm.D.





    (March 20, 2020) - - Today (March 20, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    March 20, 2020


    Statement From:

    Commissioner of Food and Drugs - Food and Drug Administration
    Stephen M. Hahn M.D.
    Associate Commissioner for Regulatory Affairs - Office of Regulatory Affairs
    Judith A. McMeekin Pharm.D.


    The U.S. Food and Drug Administration is actively and aggressively monitoring the market for any firms marketing products with fraudulent coronavirus (COVID-19) diagnostic, prevention...
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  • Coronavirus COVID-19 Update - - - FDA Allows Expanded Use of Devices to Monitor Patients’ Vital Signs Remotely

    Coronavirus COVID-19 Update - - - FDA Allows Expanded Use of Devices to Monitor Patients’ Vital Signs Remotely | site |



    (March 20, 2020) - - Today (March 20, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    Today, as part of the U.S. Food and Drug Administration’s ongoing efforts to address the coronavirus outbreak (COVID-19), the agency issued a new policy that allows manufacturers of certain FDA-cleared non-invasive, vital sign-measuring devices to expand their use so that health care providers can use them to monitor patients remotely. The devices include those that measure body temperature, respiratory rate, heart rate and blood pressure.

    “Allowing these devices to be used remotely can help health care providers access information about a patient’s vital signs while the patient is at home, reducing the need for hospital visits and minimizing the risk of exposure to coronavirus,” said FDA
    ...
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  • Coronavirus COVID-19 Update - - - FDA provides Guidance on Production of Alcohol-based Hand Sanitizer to help Boost Supply, Protect Public Health

    Coronavirus COVID-19 Update - - - FDA provides Guidance on Production of Alcohol-based Hand Sanitizer to help Boost Supply, Protect Public Health | site |




    (March 20, 2020) - - Today (March 20, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    As part of the U.S. Food and Drug Administration’s ongoing commitment to address the coronavirus (COVID-19) pandemic, the agency has issued two guidance documents to communicate its policy for the temporary manufacture of certain alcohol-based hand sanitizer products. These guidance documents will be in effect for the duration of the public health emergency declared by the Secretary of Health and Human Services (HHS) on January 31, 2020.

    “We are aware of significant supply disruptions for alcohol-based hand sanitizers. Many manufacturers make hand sanitizers, and several have indicated that they are working to increase supply,” said FDA Commissioner
    ...
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  • Coronavirus COVID-19 Update - - - FDA Continues to Facilitate Development of Treatments

    Coronavirus COVID-19 Update - - - FDA Continues to Facilitate Development of Treatments | site |




    (March 19, 2020) - - Today (March 19, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    The U.S. Food and Drug Administration continues to play a critical role in the multifaceted all-of-government response to the COVID-19 pandemic, which includes, among other things, facilitating medical countermeasures to treat and prevent the disease, and surveilling the medical product and food supply chains for potential shortages or disruptions and helping to mitigate such impacts, as necessary. As part of those efforts, President Trump has directed the FDA to continue its work with the public and private sector to ensure the availability of potentially safe and effective life-saving drugs to patients who are in desperate need, including those infected with COVID-19. The FDA has been working closely with other gove...
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  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup September 18, 2020
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup September 18, 2020 | site |



    (September 18, 2020) - - Today, September 18, 2020, the U.S. Food and Drug Administration published the following information:

    The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response to the COVID-19 pandemic:
    • The FDA reissued the Emergency Use Authorization (EUA) for the Abbott ID Now COVID-19 test. The revisions to the previous EUA letter of authorization include a revised intended use to:
      • Indicate that testing is for specimens collected “from individuals who are suspected of COVID-19 by their health care provider within the first seven days of the onset of symptoms.”
      • Clarify that testing is authorized for laboratories certified under CLIA and meet the requirements to perform high, moderate, or waived complexity tests.
      • Clarify that testing facilities within the United States and its territories
    ...
    09-21-2020, 10:14 PM
  • Staff Reporter 1
    U.S. Department of Housing and Urban Development provides 100 Million Dollars in CARES ACT Funding to Native American Tribes to support Coronavirus Recovery Efforts
    by Staff Reporter 1
    U.S. Department of Housing and Urban Development provides $100 Million in CARES ACT Funding to Native American Tribes to support Coronavirus Recovery Efforts | site |



    (August 31, 2020) - - The U.S. Department of Housing and Urban Development published (today) the following information:

    WASHINGTON - Today, the U.S. Department of Housing and Urban Development (HUD) Secretary Ben Carson announced that HUD has awarded a total of $100 million to Tribes across the Nation as part of HUD’s Indian Community Development Block Grant Imminent Threat program (ICDBG-CARES). This funding helps address problems that pose an imminent threat to public health or safety of Tribal residents and will be used to help Tribes prevent, prepare for, and respond to COVID-19. See list of funding here.

    “The Trump Administration is committed to helping families throughout Indian Country to access essential resources during the coronavirus outbreak,” said Secretary
    ...
    08-31-2020, 06:29 PM
  • Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus COVID-19 Update - - Daily Roundup May 28, 2020
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: Daily Roundup May 28, 2020| site |



    (May 28, 2020) - - Today (May 28, 2020), the U.S. Food and Drug Administration (FDA) published the following information:

    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 issued an Emergency Use Authorization for the Stryker Sustainability Solutions (SSS) VHP N95 Respirator Decontamination System (RDS). This product uses vapor hydrogen peroxide (VHP) to decontaminate compatible N95 respirators that are, or potentially are, contaminated with SARS-CoV-2 or other pathogenic microorganisms for multiple-user reuse by healthcare personnel to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of face-filtering respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic. N95 respirators containing cellulose-based materials
    ...
    05-29-2020, 07:26 AM
  • Staff Reporter 1
    Centers for Disease Control and Prevention says United States Coronavirus Death Toll Surpasses 100,000
    by Staff Reporter 1
    Centers for Disease Control and Prevention says United States Coronavirus (COVID-19) Death Toll Surpasses 100,000 | site |


    May 28, 2020) - - Today, the Centers for Disease Control and Prevention (CDC) published the following information: Today the number of people in the United States who have died from COVID-19 surpassed 100,000. Families, friends, coworkers, loved ones and community members are grieving for each person who has been lost to this disease. Reaching the milestone of 100, 000 persons lost in such a short timeframe is a sobering development and a heart-breaking reminder of the horrible toll of this unprecedented pandemic. COVID-19 has touched families in every part of America – with communities across the country experiencing the pandemic in different ways. As many communities are strategically reopening, it is important for everyone to work together to continue efforts to prevent community spread of COVID-19. We ask that all Americans continue to follow t...
    05-29-2020, 03:53 AM
  • Staff Reporter 1
    U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests
    by Staff Reporter 1
    U.S. Food and Drug Administration Provides Promised Transparency for Coronavirus COVID-19 Antibody Tests| site |



    (May 21, 2020) - - The U.S. Food and Drug Administration (FDA) published today (May 21, 2020) the following information:

    Today, the U.S. Food and Drug Administration posted a list of antibody tests that are being removed from the “notification list” of tests being offered under the Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency. Antibody tests on this new removal list include those voluntarily withdrawn from the notification list by the test’s commercial manufacturer and those for which there is not a pending Emergency Use Authorization (EUA) request or issued EUA. FDA expects that the tests on the removal list will not be marketed or distributed. Antibody tests offered by commercial manufacturers as outlined under the policy, which was issued on March 16 and updated on May 4, continue to be located on
    ...
    05-26-2020, 05:09 AM

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