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  • CMS says it Puts Patients Over Paperwork with New Rule that Addresses the Prior Authorization Process

    Centers for Medicare and Medicaid Services says it puts Patients Over Paperwork with New Rule that Addresses the Prior Authorization Process | site |



    (Information contained in Centers for Medicare and Medicaid Services press release dated: January 15, 2021) Today, the Centers for Medicare & Medicaid Services (CMS) finalized a signature accomplishment of the new Office of Burden Reduction & Health Informatics (OBRHI). This final rule builds on the efforts to drive interoperability, empower patients, and reduce costs and burden in the healthcare market by promoting secure electronic access to health data in new and innovative ways. These significant changes include allowing certain payers, providers and patients to have electronic access to pending and active prior authorization decisions, which should result in fewer repeated requests for prior authorizations, reducing costs and onerous administrative burden to our frontline providers. This final rule ...
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  • U.S. Department of Health and Human Services publishes Statements on FDA Authorization of Moderna Vaccine

    U.S. Department of Health and Human Services publishes Statements on FDA Authorization of Moderna Vaccine | site |



    (The following information was contained in a U.S. Department of Health and Human Services [HHS] press release dated: December 18, 2020)



    HHS and DoD Statements on FDA Authorization of Moderna Vaccine



    On Friday, the Food and Drug Administration announced that it had issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, the second COVID-19 vaccine to receive an EUA. Operation Warp Speed has allocated more than 5.9 million doses of the vaccine for jurisdictions to receive in the coming week. Below are statements from HHS Secretary Alex Azar and Acting Defense Secretary Christopher Miller. “On January 7, before China had reported even one death from the novel coronavirus or confirmed human-to-human transmission, NIH scientists and innovators at Moderna agreed to b...
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  • NIH publishes Statement on the FDA Emeregency Use Authorization of the Moderna COVID-19 Vaccine

    National Institutes of Health publishes Statement on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine| site |


    (The following is information contained in a National Institutes of Health [NIH] press release dated: December 18, 2020)


    Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine


    Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, for its COVID-19 vaccine, which was co-developed with scientists at the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). This innovative and monumental partnership has enabled NIH and Moderna to develop a safe and effective COVID-19 vaccine within the span of a year that will be manufactured and distributed across the U.S. The vaccine, called mRNA-1273, is a messenger...
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  • FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine

    U.S. Food and Drug Administration Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine | site |


    FDA says "Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: December 18, 2020) Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in...
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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...
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  • HHS Secretary Azar Statement on FDA Authorization of First Fully At-Home, Over-the-Counter COVID-19 Test

    U.S. Department of Health and Human Services Secretary Azar Statement on FDA Authorization of First Fully At-Home, Over-the-Counter COVID-19 Test | site |



    (The following information was contained in U.S. Department of Health and Human Services [HHS] press release: December 15, 2020) On Tuesday, the 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 that does not require a prescription, the Ellume COVID-19 Home Test, which was developed with $30 million in support from the NIH’s RADx Tech program. HHS Secretary Alex Azar issued the following statement: “FDA has authorized the first COVID-19 test that you can purchase over-the-counter, take at home, and get a rapid result, representing a major breakthrough for Americans’ ever-expanding access to convenient COVID-19 testing options. HHS provided support for this new option through NIH’s RADx in...
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  • NIH-funded COVID-19 Home Test is First to receive Over-the-counter Authorization from FDA

    National Institutes of Health-funded COVID-19 Home Test is First to receive Over-the-counter Authorization from FDA | site |


    Ellume USA’s rapid at-home test was developed through the NIH RADx Initiative.


    (Information contained in National Institutes of Health [NIH] press release: December 15, 2020)

    The U.S. Food and Drug Administration granted emergency use authorization (EUA) today for an innovative COVID-19 viral antigen test developed with support from the National Institutes of Health’s Rapid Acceleration of Diagnostics (RADx) Initiative. Ellume USA LLC, Valencia, California, designed the test for use at home without a prescription. This is the first EUA awarded for an at-home COVID test that can be purchased over the counter. Ellume developed the test with a $30 million contract and technical support from the RADx Tech program, managed by the National Institute of Biomedical Imaging and Bioengineering (NIBIB), part...
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  • American Medical Association Statement on FDA Authorization of first COVID-19 Vaccine

    American Medical Association Statement on FDA Authorization of first COVID-19 Vaccine| site |


    (Information contained in American Medical Association [AMA] press release dated: December 11, 2020)


    AMA Statement on FDA Authorization of first COVID-19 Vaccine


    The following statement is attributable to:
    Susan R. Bailey, M.D. President, American Medical Association “For much of this year, physicians, nurses and frontline health care personnel have done herculean, unprecedented work to care for patients and prevent the spread of COVID-19 – all while scientists and researchers sprinted to develop a safe and effective vaccine. After a thorough, rigorous, transparent review process, today’s decision by the FDA to grant an Emergency Use Authorization (EUA) for the first COVID-19 vaccine developed by Pfizer and BioNTech is a monumental milestone with the potential to set us on a road to recovery. The comprehensive, science-based, tr
    ...
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  • Statement from CMS Administrator Seema Verma on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate

    Statement from Centers for Medicare and Medicaid Services Administrator Seema Verma on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate | site |



    (Information contained in Centers for Medicare and Medicaid Services [CMS] press release: December 12, 2020)


    Statement from CMS Administrator Seema Verma on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate

    “Today’s announcement is a historic turning point in the fight against the virus. The beginning of the end of this chapter in our world’s history has arrived. Our hearts and minds continue to be with those who have lost loved ones, and I urge states to prioritize nursing homes and vulnerable seniors in their distribution of the vaccine. As we approach more widespread distribution, all Americans can take comfort in the fact that CMS has laid the groundwork to guarantee that every American can get the vaccine for free.”...
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  • U.S. Food and Drug Administration takes Key Action in Fight Against COVID-19 by Issuing Emergency Use Authorization for First COVID-19 Vaccine

    U.S. Food and Drug Administration takes Key Action in Fight Against COVID-19 by Issuing Emergency Use Authorization for First COVID-19 Vaccine | site |



    FDA says "Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: December 11, 2020)

    Today, the U.S. Food and Drug Administration issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. The emergency use authorization allows the Pfizer-BioNTech COVID-19 Vaccine to be distributed in the U.S. “The FDA’s authorization for emergency use of the first COVID-19 vaccine is a significant milestone in battling...
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  • Walgreens Statement Regarding FDA Emergency Use Authorization of COVID-19 Vaccine

    Walgreens Statement Regarding FDA Emergency Use Authorization of COVID-19 Vaccine | site |


    (Information contained in Walgreens press release dated: December 11, 2020) Deerfield, Ill., December 11, 2020 - The announcement from the FDA providing Pfizer with emergency use authorization on its COVID-19 vaccine is a historic milestone and important step toward ending the pandemic. We have the opportunity to turn the tide on a pandemic that has wreaked havoc on our lives and livelihoods. Walgreens is preparing to immediately bring vaccines to high-priority populations, as determined by the Centers for Disease Control (CDC) and federal and state governments. These include long-term care facility residents and staff, as well as healthcare workers. We will be collaborating with nearly 35,000 skilled nursing and assisted living facilities nationwide that have selected Walgreens as their vaccine provider. As states finalize their distribution plans, we believe we can begin ad...
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  • Statement published by HHS on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate

    Statement published by U.S. Department of Health and Human Services on FDA Emergency Use Authorization of a COVID-19 Vaccine Candidate | site |


    (Information contained in U.S. Department of Health and Human Services [HHS] press release dated: December 11, 2020) Today the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) to Pfizer for its COVID-19 vaccine, the first authorization for a COVID-19 vaccine in the United States. Operation Warp Speed and private sector partners now begin distributing the first allocation of doses to sites designated by the public health jurisdictions and five federal agencies with which OWS and CDC have been working to plan distribution. HHS Secretary Alex Azar and Acting Secretary of Defense Christopher C. Miller released the following statements: “It is nothing short of a medical miracle to have FDA authorization of a vaccine for COVID-19 just over 11 months since the virus was made known to the w...
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  • American Hospital Association Statement on FDA Emergency Use Authorization of Pfizer COVID-19 Vaccine

    American Hospital Association Statement on FDA Emergency Use Authorization of Pfizer COVID-19 Vaccine | site |



    (Information contained in American Hospital Association [AHA] press release: December 11, 2020)

    AHA Statement on FDA Emergency Use Authorization of Pfizer COVID-19 Vaccine

    Rick Pollack
    President and CEO
    American Hospital Association

    December 11, 2020


    America’s hospitals and health systems believe the announcement by the Food and Drug Administration (FDA) of an Emergency Use Authorization (EUA) of the Pfizer COVID-19 vaccine is an important step forward in ending this pandemic. This authorization was made on advice after a careful review by scientific and clinical experts through a thoughtful process. We will continue to be guided by science and follow the evidence that the FDA lays out on the safety and efficacy of the various vaccines in development. In addition to playing ...
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  • Coronavirus COVID-19 Update - - - FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate

    Coronavirus (COVID-19) Update: FDA Holds Advisory Committee Meeting to Discuss Authorization of COVID-19 Vaccine Candidate as Part of Agency’s Review of Safety and Effectiveness Data | site |


    (Information contained in U.S. Food and Drug Administration [FDA] press release: December 10, 2020)

    December 10, 2020
    Statement From:
    Commissioner of Food and Drugs - Food and Drug Administration

    Stephen M. Hahn M.D. For nearly 11 months, we have all been learning to live and function in a state of uncertainty, adjusting to a “new normal” as the COVID-19 pandemic has drastically affected the way most of us live, and has also tragically claimed the lives of hundreds of thousands of Americans. We recognize the urgent need for medical countermeasures to diagnose, treat, and prevent this novel virus and have been working diligently to facilitate their development and availability. In particular, the FDA has been working tirelessly with public
    ...
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  • HHS Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests

    U.S. Health and Human Services Secretary Alex Azar Statement on FDA Authorization of First COVID-19 Test for Home Self-Tests | site |




    (November 17, 2020) - - On November 17, 2020 the U.S. Department of Health and Human Services (HHS) published the following information: On Tuesday, the Food and Drug Administration (FDA) issued an emergency use authorization (EUA) for the first COVID-19 diagnostic at-home test, the Lucira COVID-19 All-In-One Test Kit, a molecular test that provides results in 30 minutes or less and is authorized for use by prescription only. HHS Secretary Alex Azar issued the following statement: “Making it possible for Americans to do their own rapid COVID-19 self-test at home by prescription is the latest addition to our constantly expanding arsenal of COVID-19 testing options. The Trump Administration has built the world’s largest testing system, and we will continue supporting both the development and manufacturing of cuttin...
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  • Staff Reporter 1
    CMS says it Puts Patients Over Paperwork with New Rule that Addresses the Prior Authorization Process
    by Staff Reporter 1
    Centers for Medicare and Medicaid Services says it puts Patients Over Paperwork with New Rule that Addresses the Prior Authorization Process | site |



    (Information contained in Centers for Medicare and Medicaid Services press release dated: January 15, 2021) Today, the Centers for Medicare & Medicaid Services (CMS) finalized a signature accomplishment of the new Office of Burden Reduction & Health Informatics (OBRHI). This final rule builds on the efforts to drive interoperability, empower patients, and reduce costs and burden in the healthcare market by promoting secure electronic access to health data in new and innovative ways. These significant changes include allowing certain payers, providers and patients to have electronic access to pending and active prior authorization decisions, which should result in fewer repeated requests for prior authorizations, reducing costs and onerous administrative burden to our frontline providers. This final rule ...
    01-19-2021, 05:17 AM
  • Staff Reporter 1
    U.S. Department of Health and Human Services publishes Statements on FDA Authorization of Moderna Vaccine
    by Staff Reporter 1
    U.S. Department of Health and Human Services publishes Statements on FDA Authorization of Moderna Vaccine | site |



    (The following information was contained in a U.S. Department of Health and Human Services [HHS] press release dated: December 18, 2020)



    HHS and DoD Statements on FDA Authorization of Moderna Vaccine



    On Friday, the Food and Drug Administration announced that it had issued an Emergency Use Authorization (EUA) for Moderna’s COVID-19 vaccine, the second COVID-19 vaccine to receive an EUA. Operation Warp Speed has allocated more than 5.9 million doses of the vaccine for jurisdictions to receive in the coming week. Below are statements from HHS Secretary Alex Azar and Acting Defense Secretary Christopher Miller. “On January 7, before China had reported even one death from the novel coronavirus or confirmed human-to-human transmission, NIH scientists and innovators at Moderna agreed to b...
    12-22-2020, 06:14 PM
  • Staff Reporter 1
    NIH publishes Statement on the FDA Emeregency Use Authorization of the Moderna COVID-19 Vaccine
    by Staff Reporter 1
    National Institutes of Health publishes Statement on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine| site |


    (The following is information contained in a National Institutes of Health [NIH] press release dated: December 18, 2020)


    Statement from NIH and BARDA on the FDA Emergency Use Authorization of the Moderna COVID-19 Vaccine


    Today, the U.S. Food and Drug Administration issued an Emergency Use Authorization (EUA) to Moderna, Inc., a biotechnology company based in Cambridge, Massachusetts, for its COVID-19 vaccine, which was co-developed with scientists at the National Institutes of Health's National Institute of Allergy and Infectious Diseases (NIAID). This innovative and monumental partnership has enabled NIH and Moderna to develop a safe and effective COVID-19 vaccine within the span of a year that will be manufactured and distributed across the U.S. The vaccine, called mRNA-1273, is a messenger...
    12-21-2020, 10:33 PM
  • Staff Reporter 1
    FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
    by Staff Reporter 1
    U.S. Food and Drug Administration Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine | site |


    FDA says "Action Follows Thorough Evaluation of Available Safety, Effectiveness, and Manufacturing Quality Information by FDA Career Scientists, Input from Independent Experts"


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: December 18, 2020) Today, the U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older. “With the availability of two vaccines now for the prevention of COVID-19, the FDA has taken another crucial step in...
    12-21-2020, 05:15 PM
  • Staff Reporter 1
    FDA Coronavirus COVID-19 Update - - - FDA Issues New Authorization for the BinaxNOW COVID-19 Ag Card Home Test
    by Staff Reporter 1
    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...
    12-16-2020, 10:47 PM

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