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  • U.S. Food and Drug Administration Expedites Review of Diagnostic Tests to Combat COVID-19

    U.S. Food and Drug Administration Expedites Review of Diagnostic Tests to Combat COVID-19 | site |




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



    March 30, 2020

    Statement From:

    Commissioner of Food and Drugs - Food and Drug Administration

    Stephen M. Hahn M.D.

    The U.S. Food and Drug Administration...
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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
    ...
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  • HHS Supports Mesa Biotech to Develop a Rapid Diagnostic to Detect Novel Coronavirus Infections

    HHS Supports Mesa Biotech to Develop a Rapid Diagnostic to Detect Novel Coronavirus Infections| site |



    (March 18, 2020) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information: In response to the now global pandemic, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), continues to work with its public-private partners to...
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  • HHS Supports Development of First High-Throughput COVID-19 Diagnostic Test

    HHS Supports Development of First High-Throughput COVID-19 Diagnostic Test

    U.S. Department of Health and Human Services Supports Development of First High-Throughput COVID-19 Diagnostic Test| site |




    (March 9, 2020) - - Today, the U.S. Department of Health and Human Services (HHS) published the following information:

    A diagnostic test for coronavirus disease 2019 (COVID-19) - designed for use in a diagnostic system that can process up to 1,000 tests in 24 hours - will receive advanced development support from the U.S. Department
    ...
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  • Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins

    Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins

    Shipping of CDC 2019 Novel Coronavirus Diagnostic Test Kits Begins| site |




    Distribution of CDC Diagnostic Test Kits Will Expand Laboratory Capacity to Detect 2019-nCoV


    (February 6, 2020) - - Today, the Centers for Disease Control and Prevention (CDC) published the following information: A CDC-developed laboratory test kit to detect 2019 novel coronavirus (2019-nCoV) began shipping yesterday to select qualified U.S. and international laboratorie...
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  • FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic

    U.S. Food and Drug Administration takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic| site |




    FDA says Critical Milestone Reached in Response to this Outbreak



    (February 4, 2020) - - Today (February 4, 2020), the U.S. Food and Drug Administration (FDA) published the following information: Today, the U.S Food and Drug Administration issued an ...
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