FDA Will Allow Access to COVID-19 Convalescent Plasma for Possible Treatment of Critical Patients
- March 27, 2020
The Food and Drug Administration (FDA) said March 24 it is facilitating access to COVID-19 convalescent plasma for use in patients with serious or immediately life-threatening COVID-19 infections.
According to the agency, it is investigating whether convalescent plasma that contains antibodies to SARS-CoV-2 (the virus that causes COVID-19) might be effective against the infection.
FDA noted that clinical trials are still being conducted but “given the public health emergency that the expanding COVID-19 outbreak presents,” the agency will allow access to convalescent plasma for use in critical patients through the process of single patient emergency Investigational New Drug Applications (eINDs) for Individual patients under 21 C.F.R. 312.310.