FDA updates EUA for COVID-19 convalescent plasma

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FDA updates EUA for COVID-19 convalescent plasma
tjordan_drupal
Feb 8, 2021

The Food and Drug Administration last week revised and reissued its emergency use authorization for COVID-19 convalescent plasma to treat hospitalized patients with COVID-19.

The changes include updates based on additional clinical trials; clarify the authorization’s limit to high-titer convalescent plasma for hospitalized patients early in the disease and those with impaired humoral immunity; and add to the tests acceptable for qualifying high-titer COVID-19 convalescent plasma. 

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FDA updates EUA for COVID-19 convalescent plasma
tjordan_drupal
Feb 8, 2021

The Food and Drug Administration last week revised and reissued its emergency use authorization for COVID-19 convalescent plasma to treat hospitalized patients with COVID-19.

The changes include updates based on additional clinical trials; clarify the authorization’s limit to high-titer convalescent plasma for hospitalized patients early in the disease and those with impaired humoral immunity; and add to the tests acceptable for qualifying high-titer COVID-19 convalescent plasma. 

COVID-19: CDC, FDA and CMS Guidance
COVID-19: Vaccines and Therapeutics

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