FDA, EC offer guidance on COVID-19 convalescent plasma

Regulatory NewsRegulatory News | 09 April 2020 |  By 

The US Food and Drug Administration (FDA) and European Commission (EC) recently released guidance on convalescent plasma collected from individuals who have recovered from COVID-19 and which may potentially be used as a treatment for COVID-19.

FDA’s 9-page guidance, which follows the agency’s granting of the use of single patient emergency Investigational New Drug Applications (eINDs) to the investigational plasma, is meant to provide recommendations to health care providers and investigators on the administration and study of the plasma.

The guidance discusses clinical trials, expanded access, single patient eINDs and how to obtain them, as well as information on patient eligibility and the collection of COVID-19 convalescent plasma.

“Although promising, convalescent plasma has not yet been shown to be safe and effective as a treatment for COVID-19,” FDA said, noting that its use has been studied in outbreaks of other respiratory infections too, including the 2003 SARS-CoV-1 epidemic, the 2009-2010 H1N1 influenza virus pandemic and the 2012 MERS-CoV epidemic.

The EC guidance, meanwhile, discusses COVID-19 convalescent plasma collection, testing, processing, storage and distribution. The guidance also explains how to test donated plasma and how to submit donation data and clinical outcomes data.

“EU-wide collaboration on establishing common protocols for donor recruitment, donation and gathering outcome data on a large scale will support the demonstration of safety and quality of convalescent plasma for transfusion,” the guidance adds.

FDA Guidance: Investigational COVID-19 Convalescent Plasma

EC Guidance on the collection and transfusion of convalescent COVID-19 plasma


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you

No taxonomy