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# Covid-19 Convalescent Plasma Guidance
- URL: https://www.fdaweb.com/covid-19-convalescent-plasma-guidance/
- Published: 2024-07-25T12:00:00.000Z
- Updated: 2026-09-14T14:36:29.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157433

FDA has published a guidance, *Recommendations for Investigational and Licensed Covid-19 Convalescent Plasma*, with recommendations to blood establishments for submitting a BLA for the manufacture of Covid-19 convalescent plasma for transfusion intended to treat patients with immunosuppressive disease or receiving either outpatient or inpatient immunosuppressive treatment. The [document](https://www.fda.gov/media/180209/download?ref=fdaweb.com) also has recommendations for INDs for investigational Covid-19 convalescent plasma for transfusion.

The guidance is being implemented without prior public comment, FDA says, because the agency recognizes SARS-CoV-2 continues to circulate and Covid-19 remains a serious health risk, especially for patients with immunosuppressive disease or receiving immunosuppressive therapy.

FDA says the recommendations for INDs supersede the recommendations on that issue in a 10/2023 guidance. All the other recommendations in that guidance remain in effect. The agency says it intends to withdraw the 10/2023 guidance when Covid-19 convalescent plasma is no longer authorized for emergency use.