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FDA Guidance for Industry Recommendations to Reduce the Risk of Transfusion-Transmitted Malaria

Internet:

https://www.gmp-compliance.org/files/guidemgr/Recommendations-to-Reduce-the-Risk-of-Transfusion-Transmitted-Malaria_Dec-2022.pdf

Origin/Publisher:

Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/ , http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Blood/UCM080784.pdf

Document Type:
Guidance for Industy
Content:
This guidance document provides you, blood establishments that collect blood and blood components, with FDA’s recommendations to reduce the risk of transfusion-transmitted malaria (TTM). The recommendations contained in this guidance apply to the collection of Whole Blood and blood components, except Source Plasma. Blood establishments are not required to assess Source Plasma donors for malaria risk (21 CFR 630.15(b)(8)). This guidance supersedes the guidance titled “Revised Recommendations to Replace the Risk of Transfusion-Transmitted Malaria; Guidance for Industry” dated April 2020 (April 2020 guidance).

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