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  • 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
    ...
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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 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 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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  • FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases

    FDA Approves First Treatment for Group of Progressive Interstitial Lung Diseases

    U.S. Food and Drug Administration Approves First Treatment for Group of Progressive Interstitial Lung Diseases| site |



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

    The U.S. Food and Drug Administration today approved Ofev (nintedanib) oral capsules to treat patients with chronic fibrosing (scarring) interstitial lung diseases (ILD) with a progressive phenotype (trait). It is the first FDA-approved treatment for this group of fibrosing lung diseases that worsen over time.

    “The FDA continues to encourage the development of therapies for patients with limited or no treatment options,” said Banu Karimi-Shah, M.D., acting deputy director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA’s Center for Drug Evaluation and Research. “Today’s approval helps to fulfill an unmet treatment need, as patients with these life-threatening lung diseases
    ...
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  • Coronavirus Update - - - FDA Steps to Ensure Quality of Foreign Products

    Coronavirus Update - - - FDA Steps to Ensure Quality of Foreign Products

    Coronavirus Update: U.S. Food and Drug Administration Steps to Ensure Quality of Foreign Products| site |



    (February 24, 2020) - - Today (February 24, 2020), the U.S. Food and Drug Administration (FDA) published the following information:


    Coronavirus Update: FDA steps to ensure quality of foreign products


    February 24, 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.


    Recently, we provided an update on FDA-wide activities we are engaged in related to the novel coronavirus outbreak: COVID-19. We continue to take a multi-pronged approach to this public health emergency, including focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply...
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  • FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications

    U.S. Food and Drug Administration Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications | site |




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


    Statement From:
    Director - CDRH Offices: Office of the Center Director
    Dr. Jeffrey E. Shuren MD, JD
    Director - Center for Drug Evaluation and Research
    Janet Woodcock M.D.



    Pharmacogenetic testing is a type of genetic test that in some instances can predict how a person will respond to specific medications. Thus, this type of testing offers promise for informing the selection or dosing of some medications for certain individuals. When there is sufficient scientific evidence demonstrating a relationship between how a person’s genes may impact their metabolism of a drug or how they may respond to the drug, this...
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  • National Institutes of Health Scientists Identify Atomic Structure of Novel Coronavirus Protein

    National Institutes of Health Scientists Identify Atomic Structure of Novel Coronavirus Protein | site |




    (February 19, 2020) - - Today, the National Institutes of Health's (NIH) National Institute of Allergy and Infectious Diseases (NIAID) made public the following information:

    NIAID scientists working with investigators from the University of Texas at Austin (UT) identified the atomic structure of an important protein on the surface of the novel coronavirus (SARS-CoV-2, formerly called 2019-nCoV). The findings appear in the peer-reviewed journal Science. The authors note that the findings will aid in the design of candidate vaccines and the development of treatments for COVID-19, the disease caused by the new virus, which was first identified in China in December 2019. Like other coronaviruses, SARS-CoV-2 particles are spherical and have mushroom-shaped proteins called spikes protruding from their surface, giving the particles a crown-lik...
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  • FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

    FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

    U.S. Food and Drug Administration's Actions in Response to 2019 Novel Coronavirus at Home and Abroad| site |



    (February 14, 2020) - - Today, the U.S. Food and Drug Administration (FDA) published the following statement from Stephen M. Hahn M.D., Commissioner of Food and Drugs, U.S. Food and Drug Administration: The FDA plays an essential role in overseeing our Nation’s medical products as part of our vital mission to protect and promote public health, including during public health emergencies. The FDA is an active partner in the Novel Coronavirus (COVID-19) response, working closely with our government and public health partners across the U.S. Department of Health and Human Services, as well as with our international counterparts. Our work is multifaceted, focusing on actively facilitating efforts to diagnose, treat and prevent the disease; surveilling the medical product supply chain for potential shortages or disruptions and helping to mitigate such impact...
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  • FDA Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures

    U.S. Food and Drug Administration Announces Key Actions to Advance Development of Novel Coronavirus Medical Countermeasures | site |



    (January 27, 2020) - - The U.S. Food and Drug Administration published (today, January 27, 2020) the following information:

    (Silver Spring, MD) – Today, the U.S. Food and Drug Administration (FDA) announced critical actions to advance development of novel coronavirus medical countermeasures.

    As with any emerging public health threat, the FDA will collaborate with interagency partners, product developers, international partners and global regulators to expedite the development and availability of medical products needed to diagnose, treat, mitigate and prevent such outbreaks.

    “We have a vital mission to protect and promote public health and the FDA is closely collaborating with our domestic and international public health partners to mitigate the impact of the novel coronavirus that emerged
    ...
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