The US FDA has updated its guidance on COVID-19 convalescent plasma to amend requirements for potential donors and to provide clarification on how researchers may submit investigational applications.
Previous guidance stated that eligible donors should have complete resolution of symptoms for 28 days or resolution for 14 and a negative diagnostic test. According to the new document, the FDA has amended eligibility by removing requirements for the negative COVID-19 lab test, and shortened the resolution of symptoms to at least 14 days, total.
In addition, the revised guidance also clarifies that FDA does not recommend storing a retention sample from the convalescent plasma donation for single patient emergency investigation new drug applications (INDs).
The complete guidelines are available here and at the FDA website.
