federal_register: 2012-14034

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2012-14034 Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products,” Availability Notice The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Amendment (revisions to labeling recommendations for potential risk of vCJD) to `Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products' " dated June 2012. The draft guidance document proposes amendments to the labeling recommendations for plasma-derived products, including albumin and products containing plasma-derived albumin, in the guidance document entitled "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products" dated May 2010 (2010 CJD/vCJD guidance). When finalized, the revised labeling recommendations will be incorporated into the 2010 CJD/vCJD guidance, but FDA will otherwise continue with its recommendations in the 2010 CJD/vCJD guidance as currently provided. 2012-06-11 2012 6 https://www.federalregister.gov/documents/2012/06/11/2012-14034/draft-guidance-for-industry-amendment-to-guidance-for-industry-revised-preventive-measures-to-reduce https://www.govinfo.gov/content/pkg/FR-2012-06-11/pdf/2012-14034.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 document entitled "Guidance for Industry: Amendment (revisions to labeling recommendations for potential risk of vCJD) to `Guidance for Industry: Revised Preventive...  

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