Investigational COVID-19 Convalescent Plasma | FDA

Investigational COVID-19 Convalescent Plasma | FDA

Emergency Use Authorization (EUA) updates

Guidance update: Investigational COVID-19 Convalescent Plasma The FDA updated its guidance, Investigational COVID-19 Convalescent Plasma, to provide additional information related to the recently issued EUA for the use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. This update includes a discussion regarding FDA’s intent to exercise temporary enforcement discretion regarding the IND requirements for the use of this product when blood establishments, hospitals, and health care providers collect plasma that does not meet the Conditions of Authorization of the EUA. The revised guidance continues to provide recommendations for health care providers who wish to administer and study convalescent plasma under an Investigational New Drug Application. In addition, the agency updated the web page, Recommendations for Investigational COVID-19 Convalescent Plasma, which also provides this information. (September 2, 2020)  Diagnostic test EUAs To date, the FDA has currently authorized 243 tests under EUAs; these include 195 molecular tests, 44 antibody tests, and 4 antigen tests. Also see: Coronavirus Testing Basics