federal_register: 2012-16528

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
2012-16528 Draft Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry, and Product Management To Reduce the Risk of Transfusion-Transmitted Malaria; Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of Transfusion-Transmitted Malaria" dated June 2012. The draft guidance document provides blood establishments that collect blood and blood components with recommendations for questioning and deferring donors of blood and blood components, allowing their reentry, and product management to reduce the risk of transfusion-transmitted malaria. This guidance replaces the draft guidance entitled "Guidance for Industry: Recommendations for Donor Questioning Regarding Possible Exposure to Malaria" dated June 2000. The draft guidance, when finalized, will supersede the FDA memorandum to all registered blood establishments entitled "Recommendations for Deferral of Donors for Malaria Risk" dated July 26, 1994. The recommendations contained in the draft guidance are not applicable to donors of Source Plasma. 2012-07-06 2012 7 https://www.federalregister.gov/documents/2012/07/06/2012-16528/draft-guidance-for-industry-recommendations-for-donor-questioning-deferral-reentry-and-product https://www.govinfo.gov/content/pkg/FR-2012-07-06/pdf/2012-16528.pdf Health and Human Services Department; Food and Drug Administration 221,199 The Food and Drug Administration (FDA) is announcing the availability of a draft guidance document entitled "Guidance for Industry: Recommendations for Donor Questioning, Deferral, Reentry and Product Management to Reduce the Risk of...

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