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  • Coronavirus COVID-19 Update - - - FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

    Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants | site |



    Suite of Guidances Addresses Vaccines, Diagnostics and Therapeutics


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 22, 2021) Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. “The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, M.D. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the ...
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  • Veterans Affairs says it advances Medical Research for Minority Veterans with new Genomic Tool

    U.S. Department of Veterans Affairs says it advances Medical Research for Minority Veterans with new Genomic Tool | site |



    (Information contained in U.S. Department of Veterans Affairs press release dated February 5, 2021)

    Washington - - The Department of Veterans Affairs (VA) launched a new genomic research tool designed to help VA researchers learn more about how conditions such as cancer, diabetes and heart disease affect Veterans from minority backgrounds.

    Debuting in January, the laboratory tool, known as the Ethnic Focused genotyping array or DNA chip, will test more than 750,000 genetic variants, including over 300,000 that are more common in minority populations.

    The tool was custom-built for VA’s Million Veteran Program (MVP) which studies how genes affect health. “This is potentially a game changer in medical research for Black and Hispanic Veterans and other members of minority ethnic and racial
    ...
    See more | Go to post

  • American Medical Association applauds Biden Administration on first-day Executive Actions

    American Medical Association applauds Biden Administration on first-day Executive Actions | site |


    (Information contained in American Medical Association [AMA] press release dated January 20, 2021)

    Chicago — The American Medical Association (AMA) today applauded the Biden Administration’s first-day actions that tackle the COVID-19 pandemic and climate change, re-engage with the World Health Organization (WHO), and advance racial equity, among other policies. The executive orders, memoranda, and other actions are first steps on issues critical to improving the health of the nation.


    Addressing the COVID-19 pandemic
    • Launching a “100 Days Masking Challenge”
    • Re-engaging with the WHO
    • Coordinating a unified federal response to COVID-19
    “Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus—wearing masks, practicing physical distancing,...
    See more | Go to post

  • American Medical Association Statement on HHS Decision to remove Barriers for Opioid Treatment

    American Medical Association Statement on U.S. Department of Health and Human Services Decision to remove Barriers for Opioid Treatment| site |



    (Information contained in American Medical Association [AMA] press release dated: January 14, 2021)


    The following statement is attributable to:

    Patrice Harris, M.D., M.A. Chair, AMA Opioid Task Force Immediate Past President, American Medical Association “The AMA strongly endorses today’s decision by HHS to allow physicians to prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder. Patients are struggling to find physicians who are authorized to prescribe buprenorphine; the onerous regulations discourage physicians from being certified to prescribe it. The AMA urged HHS to change the regulations last year in order to remove a major barrier to reducing the nationwide epidemic of drug-related overdose and death.
    ...
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  • American Medical Association Underscores need for Coordinated, Comprehensive Pandemic Response

    American Medical Association Underscores need for Coordinated, Comprehensive Pandemic Response | site |




    (Information contained in American Medical Association [AMA] press release dated: January 12, 2021)


    Chicago - - In a national address today, American Medical Association (AMA) President Susan R. Bailey, M.D., outlined immediate action necessary for a coordinated, comprehensive federal response to the COVID-19 pandemic. The address, titled “COVID-19: The Long Road to Recovery,” focused on steps policymakers should take to tackle the pandemic and ensure we are better prepared for future tests of our health system and public health infrastructure. Dr. Bailey also focused on the need for a science-based approach to decision making, highlighted the scientifically rigorous process that produced the COVID-19 vaccines, and urged Americans to get the vaccine when it is their turn. In the speech delivered via livestream ...
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  • 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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  • American Medical Association urges Social Media Companies to Combat Vaccine Misinformation

    American Medical Association urges Social Media Companies to Combat Vaccine Misinformation | site |


    (Information contained in American Medical Association [AMA] press release dated: December 21, 2020) Chicago - - As the United States begins an unprecedented effort to administer COVID-19 vaccines to more than 300 million Americans, the American Medical Association (AMA) today urged the CEOs of six leading social media and e-commerce companies to assist the effort by combatting misinformation and disinformation about the vaccine on their platforms. The AMA also urged the platforms to share timely, accurate information on the vaccine from trusted public health institutions, including the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. The letter was sent to the top executives at Google, Facebook, Instagram, Twitter, TikTok, and YouTube. “As we work tirelessly to stop the spread of COVID-19, please remain vigilant against...
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  • American Medical Association article says AHA, AMA, ANA urge Health Care Workers to take COVID-19 Vaccine

    American Medical Association article says AHA, AMA, ANA urge Health Care Workers to take COVID-19 Vaccine | site |


    The following information is contained in American Medical Association (AMA) press release dated December 15, 2020 and titled as follows:



    AHA, AMA, ANA urge health care workers to take COVID-19 vaccine



    Washington, DC — With the initial distribution and administration of a COVID-19 vaccine underway, leading U.S. medical, nursing and hospital organizations thanked health care professionals in an open letter today and urged them to continue their battle against COVID-19 by taking a vaccine and sharing their experience with others, noting their position as trusted and valued voices in their communities.

    The open letter from the American Medical Association, American Hospital Association, and American Nurses Association is available here. The full text is below: An open letter to all health care prof
    ...
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  • HHS and DOD Award 11.6 Million Dollars Contract to Puritan Medical Products to Boost U.S. Production of Swabs for Cue Health COVID-19 Tests

    HHS and DOD Award $11.6 Million Contract to Puritan Medical Products to Boost U.S. Production of Swabs for Cue Health COVID-19 Tests | site |


    (Information contained in U.S. Department of Health and Human Services press release: November 23, 2020) The U.S. Department of Health and Human Services (HHS) and the U.S. Department of Defense (DOD) have jointly awarded an $11.6 million contract to Puritan Medical Products Company, LLC, to expand domestic production capacity of Cue Sample Wands, the nasal swabs used exclusively with the COVID-19 cartridge-based molecular testing system developed and manufactured by Cue Health, Inc. The test generates results in about 20 minutes at the point-of-care (POC). Awarded November 19, the new contract will allow Puritan Medical to expedite upgrades at its Maine facility and increase production capability of Cue’s nasal swabs to 3 million per month by March 2021. These efforts support the federal government’s procurement of 6 millio...
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  • AMA CEO says COVID-19 is a Painful Validation of Our Long-term Vision for Health Care

    American Medical Association CEO says "COVID-19 is a Painful Validation of Our Long-term Vision for Health Care" | site |





    (Information contained in American Medical Association [AMA] press release: November 13, 2020)





    AMA CEO James L. Madara, MD



    In his address to the House of Delegates at the American Medical Association (AMA) November Special Meeting, AMA CEO James L. Madara, MD, highlights how the AMA has supported physicians during the pandemic and how COVID-19 is a painful validation of the organization’s long-term strategic vision for health care.






    ...
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  • American Medical Association Policy aimed at Combatting Misinformation about COVID-19 Vaccines

    American Medical Association Policy aimed at Combatting Misinformation about COVID-19 Vaccines | site |


    Policy aimed at educating physicians on speaking with patients about COVID-19 vaccination


    (November 17, 2020) - - On November 17, 2020 the American Medical Association (AMA) published the following information: Chicago - - With misinformation about the COVID-19 vaccine development process circulating widely, physicians at the Special Meeting of the American Medical Association (AMA) House of Delegates adopted policy today aimed at educating physicians on speaking with patients about COVID-19 vaccination, bearing in mind the historical context of “experimentation” with vaccines and other medication in communities of color, and providing physicians with culturally appropriate patient education materials. Educating the public about the safety and efficacy of the COVID-19 vaccine programs, particularly among populations that have been dispropo...
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  • American Medical Association President urges reliance on Science to Guide COVID-19 Response

    American Medical Association President urges: Rely on Science to Guide COVID-19 Response | site |


    (November 13, 2020) - - On November 13, 2020 the American Medical Association published the following information: CHICAGO — With COVID-19 cases at an all-time high, American Medical Association (AMA) President Susan R. Bailey, M.D., today addressed the Special Meeting of the American Medical Association (AMA) House of Delegates and outlined ongoing challenges in the fight against COVID-19, praised physicians and other frontline health care workers battling the virus, and discussed how only science and evidence will light our way forward. Dr. Bailey also touted AMA efforts to boost availability of PPE and testing supplies, as well as ongoing work to provide financial lifelines to physician practices across the country so they can survive the pandemic and continue to serve their communities. Finally, with significant advances regarding vaccines on the horizon, Dr. Bai...
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  • New AMA PSA urges Three Key Actions as COVID-19 Cases Spike

    New AMA PSA urges Three Key Actions as COVID-19 Cases Spike

    New American Medical Association Public Service Announcement urges Three Key Actions as COVID-19 Cases Spike | site |




    (November 11, 2020) - - On November 11, 2020 the American Medical Association (AMA) published the following information:

    CHICAGO — With record numbers of COVID-19 cases and deaths being reported across the country, the American Medical Association (AMA) today released a public service announcement (PSA) urging the general public to take three simple steps to help stop the spread of COVID-19: wash your hands frequently, practice physical distancing by staying at least six feet away from others and #MaskUp. The PSA is part of ongoing efforts by America’s physicians to urge individuals to take the necessary health and safety precautions this season to protect themselves, loved ones and the health care workers who are on the front lines handling the dramatic increase in cases.




    ...
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  • FDA Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development

    U.S. Food and Drug Administration Offers Guidance to Enhance Diversity in Clinical Trials, Encourage Inclusivity in Medical Product Development | site |




    (November 9, 2020) - - Today the U.S. Food and Drug Administration (FDA) published the following information:


    November 09, 2020

    Statement From: Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D. Throughout my career as a cancer doctor and medical researcher, I have been concerned about and have sought to address issues related to health care disparities. One important step that researchers and medical product sponsors can take to confront health care disparities is to make sure that clinical trials for medical products are more inclusive of multiple populations. We have seen these health care disparities, for example, during our fight against COVID-19, as certain segments of the population (e.g., older adults, pregnant women, children, a
    ...
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  • FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order

    FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order| site |



    (October 30, 2020) - - Today, October 30, 2020, the U.S. Food and Drug Administration (FDA) published the following information:

    Statement From:
    Commissioner of Food and Drugs - Food and Drug Administration
    Stephen M. Hahn M.D.

    As the U.S. Food and Drug Administration continues our work to address the current pandemic, we are also looking ahead to prepare for the next potential public health emergency. A recent executive order directed the agency, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms. The goal of this work is to ensure the American public is protected against outbreaks of emerging
    ...
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  • Staff Reporter 1
    Coronavirus COVID-19 Update - - - FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants
    by Staff Reporter 1
    Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants | site |



    Suite of Guidances Addresses Vaccines, Diagnostics and Therapeutics


    (Information contained in U.S. Food and Drug Administration [FDA] press release dated: February 22, 2021) Today, the U.S. Food and Drug Administration issued guidances for medical product developers, specifically covering vaccines, diagnostics and therapeutics products, to address the emergence and potential future emergence of variants of SARS-CoV-2, the virus that causes COVID-19. “The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, M.D. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the ...
    02-25-2021, 11:52 AM
  • Staff Reporter 1
    Veterans Affairs says it advances Medical Research for Minority Veterans with new Genomic Tool
    by Staff Reporter 1
    U.S. Department of Veterans Affairs says it advances Medical Research for Minority Veterans with new Genomic Tool | site |



    (Information contained in U.S. Department of Veterans Affairs press release dated February 5, 2021)

    Washington - - The Department of Veterans Affairs (VA) launched a new genomic research tool designed to help VA researchers learn more about how conditions such as cancer, diabetes and heart disease affect Veterans from minority backgrounds.

    Debuting in January, the laboratory tool, known as the Ethnic Focused genotyping array or DNA chip, will test more than 750,000 genetic variants, including over 300,000 that are more common in minority populations.

    The tool was custom-built for VA’s Million Veteran Program (MVP) which studies how genes affect health. “This is potentially a game changer in medical research for Black and Hispanic Veterans and other members of minority ethnic and racial
    ...
    02-10-2021, 04:05 AM
  • Staff Reporter 1
    American Medical Association applauds Biden Administration on first-day Executive Actions
    by Staff Reporter 1
    American Medical Association applauds Biden Administration on first-day Executive Actions | site |


    (Information contained in American Medical Association [AMA] press release dated January 20, 2021)

    Chicago — The American Medical Association (AMA) today applauded the Biden Administration’s first-day actions that tackle the COVID-19 pandemic and climate change, re-engage with the World Health Organization (WHO), and advance racial equity, among other policies. The executive orders, memoranda, and other actions are first steps on issues critical to improving the health of the nation.


    Addressing the COVID-19 pandemic
    • Launching a “100 Days Masking Challenge”
    • Re-engaging with the WHO
    • Coordinating a unified federal response to COVID-19
    “Defeating COVID-19 requires bold, coordinated federal leadership and strong adherence to the public health steps we know stop the spread of this virus—wearing masks, practicing physical distancing,...
    01-23-2021, 06:46 AM
  • Staff Reporter 1
    American Medical Association Statement on HHS Decision to remove Barriers for Opioid Treatment
    by Staff Reporter 1
    American Medical Association Statement on U.S. Department of Health and Human Services Decision to remove Barriers for Opioid Treatment| site |



    (Information contained in American Medical Association [AMA] press release dated: January 14, 2021)


    The following statement is attributable to:

    Patrice Harris, M.D., M.A. Chair, AMA Opioid Task Force Immediate Past President, American Medical Association “The AMA strongly endorses today’s decision by HHS to allow physicians to prescribe without a waiver highly effective medication for the treatment of patients with opioid use disorder. Patients are struggling to find physicians who are authorized to prescribe buprenorphine; the onerous regulations discourage physicians from being certified to prescribe it. The AMA urged HHS to change the regulations last year in order to remove a major barrier to reducing the nationwide epidemic of drug-related overdose and death.
    ...
    01-19-2021, 02:34 AM
  • Staff Reporter 1
    American Medical Association Underscores need for Coordinated, Comprehensive Pandemic Response
    by Staff Reporter 1
    American Medical Association Underscores need for Coordinated, Comprehensive Pandemic Response | site |




    (Information contained in American Medical Association [AMA] press release dated: January 12, 2021)


    Chicago - - In a national address today, American Medical Association (AMA) President Susan R. Bailey, M.D., outlined immediate action necessary for a coordinated, comprehensive federal response to the COVID-19 pandemic. The address, titled “COVID-19: The Long Road to Recovery,” focused on steps policymakers should take to tackle the pandemic and ensure we are better prepared for future tests of our health system and public health infrastructure. Dr. Bailey also focused on the need for a science-based approach to decision making, highlighted the scientifically rigorous process that produced the COVID-19 vaccines, and urged Americans to get the vaccine when it is their turn. In the speech delivered via livestream ...
    01-15-2021, 09:44 PM

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