FDA Updates Guidance on COVID-19 Convalescent Plasma Use

The FDA has updated its guidance on the use of convalescent plasma to treat COVID-19 or in clinical trials of treatments to take account of the administration’s Aug. 23 Emergency Use Authorization (EUA).

“Ongoing clinical trials of investigational convalescent plasma should not be amended based on the issuance of the EUA,” the agency said.

Researchers may administer convalescent plasma under the investigational new drug (IND) regulatory pathway, a single-patient IND for emergency use or an intermediate-size population expanded access IND.

The EUA will remain in effect “only for the duration of the public health emergency related to COVID-19 declared by HHS on Jan. 31,” the FDA says.

The guidance also includes recommendations to blood banks on plasma collection, and to all concerned on labeling and recordkeeping requirements.

The updated guidance replaces guidance the agency issued in April and updated in May on the same subject, under the same title.

The FDA will accept comments on the guidance at any time.

Read the updated guidance here: www.fdanews.com/09-03-20-InvestigationalCOVID19ConvalescentPlasma.pdf. — Martin Berman-Gorvine