FDA issues guidance on using investigational convalescent plasma

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FDA issues guidance on using investigational convalescent plasma
tjordan_drupal
Nov 17, 2020

The Food and Drug Administration yesterday issued final guidance for health care providers and researchers using investigational COVID-19 convalescent plasma, defined as convalescent plasma that does not meet all conditions of the agency’s emergency use authorization or which is used under an investigational new drug application during the public health emergency.

The updated guidance extends enforcement discretion through February 2021 to allow continued access to convalescent plasma for hospitalized COVID-19 patients while blood establishments develop operating procedures to manufacture the plasma consistent with the EUA.

The guidance also advises against collecting convalescent plasma from individuals who have received an investigational COVID-19 vaccine because the quality of the immune response from such vaccines is uncertain.

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FDA issues guidance on using investigational convalescent plasma
tjordan_drupal
Nov 17, 2020

The Food and Drug Administration yesterday issued final guidance for health care providers and researchers using investigational COVID-19 convalescent plasma, defined as convalescent plasma that does not meet all conditions of the agency’s emergency use authorization or which is used under an investigational new drug application during the public health emergency.

The updated guidance extends enforcement discretion through February 2021 to allow continued access to convalescent plasma for hospitalized COVID-19 patients while blood establishments develop operating procedures to manufacture the plasma consistent with the EUA.

The guidance also advises against collecting convalescent plasma from individuals who have received an investigational COVID-19 vaccine because the quality of the immune response from such vaccines is uncertain.

Novel Coronavirus (COVID-19)
COVID-19: CDC, FDA and CMS Guidance

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