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Thread: FDA Orders Companies To Submit Antibody Test Data

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    Default FDA Orders Companies To Submit Antibody Test Data

    Sheila Kaplan
    May 4 2020

    The agency had come under fire from members of Congress and other groups for allowing dozens of wildly inaccurate tests to proliferate

    The Food and Drug Administration announced on Monday that companies selling coronavirus antibody tests must submit data proving accuracy within the next 10 days or face removal from the market.
    The antibody tests are an effort to detect whether a person had been infected with the coronavirus, but results have been widely varied. Since mid-March, the agency has permitted dozens of manufacturers to sell the tests without providing evidence that they are accurate.

    Read more: https://www.nytimes.com/2020/05/04/h...8b0e20e9725adc
    Last edited by Islander; 4 Weeks Ago at 10:11 PM.

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