Notices. Notice; withdrawal
293 words·~1 min read·
/register/2020/09/21/2020-20801·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4164-01-P 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. 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. [FR Doc. 2020-20801 Filed 9-18-20; 8:45 am]