REGULATORY UPDATE: FDA Issues New Guidance on COVID-19 Convalescent Plasma; AABB Toolkit Available

The Food and Drug Administration issued final guidance on Monday for immediate implementation, providing blood establishments and sponsors with current recommendations to expedite the development of COVID-19 convalescent plasma (CCP).

Titled "Recommendations for Investigational and Licensed COVID-19 Convalescent Plasma," the guidance outlines two regulatory pathways for CCP manufacturing. It includes recommendations for blood establishments to submit a biologics license application (BLA) for CCP intended to treat patients with immunosuppressive diseases or those receiving immunosuppressive treatment, in both outpatient and inpatient settings. Additionally, the guidance offers recommendations for investigational new drug (IND) applications for investigational CCP intended for transfusion.

The guidance includes the following notable recommendations:

• Registered-only blood establishments must submit a BLA to ensure "consistent manufacturing." FDA describes that manufacturing of CCP involves unique considerations, including donor selection and component suitability (titer).
• The dating period for CCP should be six months from the date of collection.
• Once the emergency use authorization (EUA) is revoked, FDA does not plan to object to the distribution or use of CCP manufactured under the EUA. However, manufacturers should consider whether the products are likely to contain antibodies against the currently circulating strains of COVID-19. FDA recommend units more than six months from the date of collection not be distributed as CCP.

In a Federal Register notice (FRN), the FDA specified that the recommendations in section III.A.2 of today's guidance supersede the recommendations in section III.C. of the "Investigational COVID-19 Convalescent Plasma" guidance issued in October. While the FDA released the guidance for immediate implementation, the agency is accepting comments. Submission instructions are available in the FRN.

AABB Toolkit Available 

AABB’s Department of Regulatory Affairs released a toolkit (member-protected) on Tuesday that provides members with resources to support the submission of a BLA for licensure. This and other members-only toolkits are available on AABB'S Regulatory Toolkits for Members web page. Those with questions may contact regulatory@aabb.org.