Guidance Issued on Investigational COVID-19 Convalescent Plasma

On Feb. 11, 2021, FDA published guidance that gives recommendations to health care providers and investigators on the use of COVID-19 convalescent plasma or investigational convalescent plasma. Recommendations are also provided regarding blood collection.The document also discusses the agency’s interim compliance and enforcement policy for investigational new drug requirements for the use of investigational convalescent plasma.

The new guidance, which supersedes guidance issued in January 2021 and previous versions, includes revised recommendations for convalescent plasma donors. “The revisions address when individuals who have received an investigational COVID-19 monoclonal antibody therapy as a participant in a clinical trial, or received an authorized or licensed COVID-19 monoclonal antibody therapy, qualify as convalescent plasma donors,” the guidance states.

Recommendations for qualification and labeling of high titer COVID-19 convalescent plasma under the Emergency Use Authorization have also been revised. The guidance was also updated to “note that FDA intends to exercise enforcement discretion related to the investigational new drug requirements for use of convalescent plasma including when, among other circumstances, the donor meets the qualifications for individuals who have received a COVID-19 vaccine or COVID-19 monoclonal antibody therapy in accordance with section III.B.1 of this guidance.”

Source: FDA