United States Food and Drug Administration Issues Guidance on COVID-19 Convalescent Plasma
The Food and Drug Administration (FDA) announced on April 8, 2020 the issuance of final guidance regarding the administration and study of convalescent plasma collected from individuals who have recovered from COVID-19. The use of COVID-19 convalescent plasma is regulated by the FDA as an investigational product, and health care providers wishing to use this therapy as an option must therefore participate in investigational pathways. The guidance provides information on this and a variety of topics as listed below:
- pathways for use of investigational COVID-19 convalescent plasma,
- patient eligibility,
- collection of COVID-19 convalescent plasma, including donor eligibility and donor qualifications,
- labeling, and
- recordkeeping
