USA – COVID convalescent plasma guidance gets EUA updates

Guidance for industry on the use of convalescent plasma for patients with COVID-19 has been updated to reflect the 23 August Emergency Use Authorization (EUA) for the investigational product. The guidance clarifies which pathways are available for use of COVID-19 convalescent plasma and announces a period of enforcement discretion for transition to collection requirements outlined in the EUA.
 
Updates to the US Food and Drug Administration (FDA) guidance account for the addition of the EUA pathway for use of investigational convalescent plasma to the original Investigational New Drug (IND) pathway that was delineated the April 2020 version of the guidance and updated the next month. (RELATED: FDA updates guidance on investigational use of convalescent plasma for COVID-19, Regulatory Focus 04 May 2020)…