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  • FDA Coronavirus (COVID-19) Update - - - Daily Roundup October 23, 2020

    FDA Coronavirus (COVID-19) Update - - - Daily Roundup October 23, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020
    | site |



    (October 23, 2020) - - Today, October 23, 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:
    • On Thursday, the FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. The FDA revised the Emergency Use Authorization (EUA) for Veklury to remove those uses that are now approved under Gilead’s New Drug Application (NDA). The EUA for Veklury continues
    ...
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  • FDA Approves First Treatment for COVID-19

    FDA Approves First Treatment for COVID-19

    U.S. Food and Drug Administration Approves First Treatment for COVID-19 | site |




    (October 22, 2020) - - Today, October 22, 2020, the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered und
    ...
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  • U.S. Administration Adds 1,275 Miles to the National Trail System

    U.S. Administration Adds 1,275 Miles to the National Trail System

    Trump Administration Adds 1,275 Miles to the National Trail System | site |



    30 trails designated, continued expansion of outdoor recreation



    (October 22, 2020) - - Today, October 22, 2020, the U.S. Department of the Interior published the following information:

    BOULDER CITY, Nev. — U.S. Secretary of the Interior David L. Bernhardt announced 30 new national recreation trails in 25 states, adding more than 1,275 miles to the National Trails System. Secretary Bernhardt made the announcement from Lake Mead National Recreation Area, where he designated 76 miles of the Colorado River within Lake Mead National Recreation Area as a national water trail. The newly designated Mohave National Water Trail begins where the Black Canyon National Water Trail ends, providing water recreation opportunities for 106 miles along the Colorado River.


    Today’s announcement is in addition to the 370 miles of national recreation trails...
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  • Trump Administration Provides Saliva Test at Surge Testing Site in Waco, TX

    Trump Administration Provides Saliva Test at Surge Testing Site in Waco, TX

    Trump Administration Provides Saliva Test at Surge Testing Site in Waco, TX | site |




    Test Bolstered Through NIH Rapid Acceleration of Diagnostics (RADxSM) Initiative


    (October 16, 2020) - - Today, October 16, 2020, the U.S. Department of Health and Human Services (HHS) published the following information:

    Starting today, communities that are part of the federal surge testing effort for COVID-19, supported by the Trump Administration, have a new option: a test that uses samples of saliva collected by spitting into a sterile container. Made by Fluidigm Corporation and supported in part by the National Institutes of Health (NIH), the easy-to-use saliva test detects SARS-CoV-2, the virus that causes COVID-19, on a molecular level using a microfluidics platform. The accuracy of the test is comparable to other molecular-level tests of nasal swab samples, according to a clinical study conducted by the manufacturer. The U.S.
    ...
    See more | Go to post

  • FDA Coronavirus (COVID-19) Update - - - Daily Roundup October 20, 2020

    FDA Coronavirus (COVID-19) Update - - - Daily Roundup October 20, 2020

    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: Daily Roundup October 20, 2020 | site |




    (October 20, 2020) - - Today, October 20, 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 posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., and Dr. Peter Marks, the Director of FDA's Center for Biologics Evaluation and Research, discussing the upcoming Vaccines and Related Biological Products Advisory Committee meeting on October 22, 2020.
    ...
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  • Trump Administration Announces Historically Low Premiums and New Insulin Benefit as Medicare Open Enrollment Begins

    Trump Administration Announces Historically Low Premiums and New Insulin Benefit as Medicare Open Enrollment Begins | site |



    Medicare Parts A & B


    (October 15, 2020) - - Today, October 15, 2020, the Centers for Medicare & Medicaid Services published the following information: Today, the Centers for Medicare & Medicaid Services (CMS) announced that 2021 Medicare Open Enrollment is officially open and will run through December 7, 2020. More than 60 million people with Medicare can review health and drug plans, and make changes to their healthcare coverage for next year, based on their financial and medical needs, from the comfort of their homes. With Medicare Advantage (or private Medicare health plans) and Part D prescription drug plan premiums at historic lows – and hundreds of healthcare plans now offering $35 monthly co-pays for insulin – there are plenty of reasons to compare coverage options. As part of this year’s open enro...
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  • Trump Administration Welcomes Amazon to the U.S. Food Loss and Waste 2030 Champions

    Trump Administration Welcomes Amazon to the U.S. Food Loss and Waste 2030 Champions | site |




    (October 16, 2020) - - Today, October 16, 2020, the U.S. Department of Agriculture published the following information:

    WASHINGTON (Oct. 16, 2020) — Today, on World Food Day, U.S. Environmental Protection Agency (EPA) Administrator Andrew Wheeler and U.S. Department of Agriculture (USDA) Secretary Sonny Perdue welcomed Amazon as a new member of the U.S. Food Loss and Waste 2030 Champions. Champions are U.S. businesses and organizations that pledge to reduce food loss and waste in their own operations by 50 percent by the year 2030. The commitment and action of these businesses will help the U.S. move closer to the national goal, protect and save valuable resources, and improve food system efficiencies while reducing waste.

    “The Trump Administration is leading the way in combating food waste, and the addition of Amazon to our Food Loss
    ...
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  • HHS says Trump Administration Partners with CVS and Walgreens to Provide COVID-19 Vaccine

    U.S. Dept. of Health and Human Services says Trump Administration Partners with CVS and Walgreens to Provide COVID-19 Vaccine to Protect Vulnerable Americans in Long-Term Care Facilities Nationwide | site |




    (October 16, 2020) - - Today, October 16, 2020, the U.S. Department of Health and Human Services (HHS) published the following information:

    To meet the Trump Administration's Operation Warp Speed (OWS) goals, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD exit disclaimer icon) today announced agreements with CVS and Walgreens to provide and administer COVID-19 vaccines to residents of long-term care facilities (LTCF) nationwide with no out-of-pocket costs. Protecting especially vulnerable Americans has been a critical part of the Trump Administration’s work to combat COVID-19, and LTCF residents may be part of the prioritized groups for initial COVID-19 vaccination efforts until there are enough
    ...
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  • Trump Administration Drives Telehealth Services in Medicaid and Medicare

    Trump Administration Drives Telehealth Services in Medicaid and Medicare

    Trump Administration Drives Telehealth Services in Medicaid and Medicare | site |


    (October 14, 2020) - - The Centers for Medicare and Medicaid Services published today, October 14, 2020, the following information: Today, the Centers for Medicare & Medicaid Services (CMS) expanded the list of telehealth services that Medicare Fee-For-Service will pay for during the coronavirus disease 2019 (COVID-19) Public Health Emergency (PHE). CMS is also providing additional support to state Medicaid and Children’s Health Insurance Program (CHIP) agencies in their efforts to expand access to telehealth. The actions reinforce President Trump’s Executive Order on Improving Rural Health and Telehealth Access to improve the health of all Americans by increasing access to better care. “Responding to President Trump’s Executive Order, CMS is taking action to increase telehealth adoption across the country,” said CMS Administrator Seema Verma. “Medicaid patients should not be ...
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  • U.S. Food and Drug Administration Approves First Treatment for Ebola Virus

    U.S. Food and Drug Administration Approves First Treatment for Ebola Virus

    U.S. Food and Drug Administration Approves First Treatment for Ebola Virus | site |


    (October 14, 2020) - - The U.S. Food and Drug Administration (FDA) published today, October 14, 2020, the following information:

    Today, the U.S. Food and Drug Administration approved Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), a mixture of three monoclonal antibodies, as the first FDA-approved treatment for Zaire ebolavirus (Ebola virus) infection in adult and pediatric patients.

    “Today’s action demonstrates the FDA’s ongoing commitment to responding to public health threats—both domestically and abroad—on the basis of science and data,” said FDA Commissioner Stephen M. Hahn, M.D. “This approval was made possible because of our steadfast dedication to facilitate the development of safe and effective treatments for infectious diseases as part of our vital public health mission.”

    Zaire ebolavirus, commonly known as Ebola virus, is one
    ...
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  • U.S. Social Security Administration Announces 1.3 Percent Benefit Increase for 2021

    U.S. Social Security Administration Announces 1.3 Percent Benefit Increase for 2021 | site |


    (October 13, 2020) - - Today, October 13, 2020, the U.S. Social Security Administration published the following information: Social Security and Supplemental Security Income (SSI) benefits for approximately 70 million Americans will increase 1.3 percent in 2021, the Social Security Administration announced today. The 1.3 percent cost-of-living adjustment (COLA) will begin with benefits payable to more than 64 million Social Security beneficiaries in January 2021. Increased payments to more than 8 million SSI beneficiaries will begin on December 31, 2020. (Note: some people receive both Social Security and SSI benefits). The Social Security Act ties the annual COLA to the increase in the Consumer Price Index as determined by the Department of Labor’s Bureau of Labor Statistics. Some other adjustments that take effect in January of each year are based on the increase in a...
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  • U.S. Food and Drug Administration Coronavirus - - - COVID-19 - - - Update: Daily Roundup October 13, 2020

    U.S. Food and Drug Administration Coronavirus - - - COVID-19 - - - Update: Daily Roundup October 13, 2020 | site |


    (October 13, 2020) - - Today, October 13, 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:
    ...
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  • Federal Housing Administration launches FHA Catalyst Electronic Multifamily Application Submission Capabilities

    Federal Housing Administration launches FHA Catalyst Electronic Multifamily Application Submission Capabilities | site |



    First FHA Catalyst module for Multifamily lenders will eliminate paper-based submissions of FHA insurance applications


    (October 14, 2020) - - Today, the U.S. Department of Housing and Urban Development published the following information:

    WASHINGTON - The Federal Housing Administration (FHA) today announced the availability of the first module on its FHA Catalyst technology platform for Multifamily lenders doing business with FHA. The FHA Catalyst: Multifamily Applications module will allow eligible Multifamily lenders to electronically submit applications for FHA insurance on multifamily properties. The new capability supports lenders in providing FHA-insured mortgage financing while working remotely because of the COVID-19 National Emergency. Multifamily lenders currently submit insurance applications – usually
    ...
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  • Trump Administration Makes Major Investment to Increase Availability of Fast Molecular POC Test

    Trump Administration Makes Major Investment to Increase Availability of Fast Molecular POC Test | site |


    Federal investment will scale up portable molecular test and acquire for national use


    (October 13, 2020) - - Today, October 13, 2020, the U.S. Department of Health and Human Services published the following information: Today, the U.S. Department of Health and Human Services (HHS) in collaboration with the Department of Defense (DOD) awarded a $481 million Other Transaction Agreement to Cue Health, Inc. to expand U.S. production capacity for a cartridge-based point-of-care COVID-19 molecular test that produces results in about 20 minutes. This partnership with HHS and DOD will allow Cue to expand its industrial base and increase domestic production to 100,000 COVID-19 test kits per day by March 2021, and demonstrate this capacity through the delivery of six million COVID-19 tests and 30,000 instruments to the U.S. Government to support the...
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  • U.S. Small Business Administration Proposes Small Business Size Standard Revisions in Eight Industrial Sectors

    U.S. Small Business Administration Proposes Small Business Size Standard Revisions in Eight Industrial Sectors to Increase Small Business Eligibility for Contracting and Loan Programs | site |

    ​​​​​​

    Public Comments Due by Dec. 1



    (October 2, 2020) - - Today, October 2, 2020, the U.S. Small Business Administration published the following information: The U.S. Small Business Administration is seeking public comments on two proposed rules that would revise the small business size standards for businesses in eight North American Industrial Classification System (NAICS) sectors to increase small business eligibility for SBA’s loan and contracting programs. The NAICS sectors reviewed in the first proposed rule are: Agriculture, Forestry, Fishing, and Hunting; Mining, Quarrying, and Oil and Gas Extraction; Utilities; and Construction. The NAICS sectors reviewed in the second proposed rule are: Transportation and Warehousing; Informatio
    ...
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  • Staff Reporter 1
    FDA Coronavirus (COVID-19) Update - - - Daily Roundup October 23, 2020
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: Daily Roundup October 23, 2020
    | site |



    (October 23, 2020) - - Today, October 23, 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:
    • On Thursday, the FDA approved Veklury (remdesivir), the first drug approved to treat COVID-19, for use in adults and pediatric patients (12 years of age and older and weighing at least 40 kg) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. The FDA revised the Emergency Use Authorization (EUA) for Veklury to remove those uses that are now approved under Gilead’s New Drug Application (NDA). The EUA for Veklury continues
    ...
    10-24-2020, 12:19 AM
  • Staff Reporter 1
    FDA Approves First Treatment for COVID-19
    by Staff Reporter 1
    U.S. Food and Drug Administration Approves First Treatment for COVID-19 | site |




    (October 22, 2020) - - Today, October 22, 2020, the U.S. Food and Drug Administration (FDA) published the following information:

    Today, the U.S. Food and Drug Administration approved the antiviral drug Veklury (remdesivir) for use in adult and pediatric patients 12 years of age and older and weighing at least 40 kilograms (about 88 pounds) for the treatment of COVID-19 requiring hospitalization. Veklury should only be administered in a hospital or in a healthcare setting capable of providing acute care comparable to inpatient hospital care. Veklury is the first treatment for COVID-19 to receive FDA approval. This approval does not include the entire population that had been authorized to use Veklury under an Emergency Use Authorization (EUA) originally issued on May 1, 2020. In order to ensure continued access to the pediatric population previously covered und
    ...
    10-23-2020, 10:22 AM
  • Staff Reporter 1
    U.S. Administration Adds 1,275 Miles to the National Trail System
    by Staff Reporter 1
    Trump Administration Adds 1,275 Miles to the National Trail System | site |



    30 trails designated, continued expansion of outdoor recreation



    (October 22, 2020) - - Today, October 22, 2020, the U.S. Department of the Interior published the following information:

    BOULDER CITY, Nev. — U.S. Secretary of the Interior David L. Bernhardt announced 30 new national recreation trails in 25 states, adding more than 1,275 miles to the National Trails System. Secretary Bernhardt made the announcement from Lake Mead National Recreation Area, where he designated 76 miles of the Colorado River within Lake Mead National Recreation Area as a national water trail. The newly designated Mohave National Water Trail begins where the Black Canyon National Water Trail ends, providing water recreation opportunities for 106 miles along the Colorado River.


    Today’s announcement is in addition to the 370 miles of national recreation trails...
    10-23-2020, 08:59 AM
  • Staff Reporter 1
    Trump Administration Provides Saliva Test at Surge Testing Site in Waco, TX
    by Staff Reporter 1
    Trump Administration Provides Saliva Test at Surge Testing Site in Waco, TX | site |




    Test Bolstered Through NIH Rapid Acceleration of Diagnostics (RADxSM) Initiative


    (October 16, 2020) - - Today, October 16, 2020, the U.S. Department of Health and Human Services (HHS) published the following information:

    Starting today, communities that are part of the federal surge testing effort for COVID-19, supported by the Trump Administration, have a new option: a test that uses samples of saliva collected by spitting into a sterile container. Made by Fluidigm Corporation and supported in part by the National Institutes of Health (NIH), the easy-to-use saliva test detects SARS-CoV-2, the virus that causes COVID-19, on a molecular level using a microfluidics platform. The accuracy of the test is comparable to other molecular-level tests of nasal swab samples, according to a clinical study conducted by the manufacturer. The U.S.
    ...
    10-22-2020, 04:05 AM
  • Staff Reporter 1
    FDA Coronavirus (COVID-19) Update - - - Daily Roundup October 20, 2020
    by Staff Reporter 1
    U.S. Food and Drug Administration Coronavirus (COVID-19) Update: Daily Roundup October 20, 2020 | site |




    (October 20, 2020) - - Today, October 20, 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 posted a new “FDA Insight” podcast featuring Deputy Commissioner Anand Shah, M.D., and Dr. Peter Marks, the Director of FDA's Center for Biologics Evaluation and Research, discussing the upcoming Vaccines and Related Biological Products Advisory Committee meeting on October 22, 2020.
    ...
    10-22-2020, 02:03 AM

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