FDA Sets Rules for Using Blood Plasma In and Outside COVID-19 Trials
Researchers planning trials on the use of convalescent blood plasma to treat COVID-19 must submit an investigational new drug (IND) application, according to a new FDA final guidance that will remain in effect only for the duration of the public health emergency.
Because blood plasma collected from recovered COVID-19 patients does not yet have FDA approval for broad public use, the agency is requiring investigators and healthcare providers to follow one of three pathways already established for requesting permission to use an investigational product.
Clinical trials should use the traditional IND process and provide evidence that the plasma to be used will be obtained from an FDA-registered blood establishment. The agency’s Center for Biologics Evaluation and Research has committed to reviewing such IND applications “expeditiously,” the straight-to-final guidance states.
Physicians not involved in a clinical trial have two other options for gaining FDA permission to administer convalescent blood plasma to their COVID-19 patients. For patients with serious or immediately life-threatening conditions who are unable to participate in a clinical trial, physicians may request expanded access to the product through an acute care facility that already holds an IND for COVID-19 convalescent
If neither a trial nor expanded access is available, an individual patient’s physician may request a single-patient emergency IND from the agency.
The FDA will accept comments on the guidance at any time.
Read the guidance here: https://bit.ly/39XFZlR.