Document ID: FDA-2020-D-1825-0011
Agency: fda
Document Type: Notice
Title: Investigational COVID–19 Convalescent Plasma; Guidance for Industry; Withdrawal of Guidance
Posted Date: 2020-09-21T04:00Z

[Federal Register Volume 85, Number 183 (Monday, September 21, 2020)]
[Notices]
[Pages 59320-59321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-20801]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-1825]

Investigational COVID-19 Convalescent Plasma; Guidance for 
Industry; Withdrawal of Guidance

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice; withdrawal.

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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

[[Page 59321]]

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.
[FR Doc. 2020-20801 Filed 9-18-20; 8:45 am]
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