# Investigational COVID-19 Convalescent Plasma; Guidance for Industry; Withdrawal of Guidance
**AGENCY:**
Food and Drug Administration, Health and Human Services (HHS).
**ACTION:**
Notice; withdrawal.
**SUMMARY:**
The Food and Drug Administration (FDA or Agency) is announcing the withdrawal of a final guidance for industry entitled “Investigational COVID-19 Convalescent Plasma,” which was issued in April 2020 and updated in May 2020. FDA is withdrawing the guidance because the Agency is issuing a new guidance for industry of the same title.
**DATES:**
The withdrawal is applicable September 21, 2020.
**FOR FURTHER INFORMATION CONTACT:**
Shruti Modi, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911.
**SUPPLEMENTARY INFORMATION:**
FDA is withdrawing the guidance for industry entitled “Investigational COVID-19 Convalescent Plasma” (May 2020 guidance) dated April 2020 and updated May 2020. The availability of this guidance was announced in the *Federal Register* of May 26, 2020, (85 FR 31513) and was posted on FDA's website on May 1, 2020.
On August 23, 2020, the Agency issued an emergency use authorization (EUA) (available at: *https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#coviddrugs* ) for COVID-19 convalescent plasma for the treatment of hospitalized patients with COVID-19. Given the issuance of this EUA, FDA is issuing a new guidance of the same title that provides recommendations and additional information related to the EUA for the use of COVID-19 convalescent plasma to treat hospitalized patients with COVID-19. The new guidance supersedes the May 2020 guidance. Elsewhere in this issue of the *Federal Register* , FDA is announcing the availability of the new guidance.
Dated: September 16, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.