Drug Regulators, FDA, Publish Revised Preventative Measure to Reduce Risk of Transmission of Creutzfeld-Jakob Disease and Variant Disease
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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
This guidance is the latest in a series of guidances addressing the risk of CJD and vCJD transmission by blood and blood products. In 1999, we, FDA, issued a guidance entitled “Guidance for Industry: Revised Precautionary Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products” dated November 1999. Later, we issued a guidance 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 January 2002 (2002 guidance). Still later, we issued a draft guidance entitled “Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible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Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products,’” dated August 2006 (2006 draft guidance).
FDA continues to monitor epidemiological findings and other scientific data regarding CJD and vCJD , and accordingly, is issuing this guidance to amend the 2002 guidance by: a) finalizing the donor deferral recommendation from the 2006 draft guidance (for donors who have received a transfusion of blood or blood components in France since 1980); b) providing updated scientific information; and c) revising labeling recommendations for Whole Blood and blood components intended for transfusion. This final guidance provides comprehensive recommendations, including our most recent recommendation to defer donors who have received a transfusion of blood or blood components in France since 1980, to blood collecting establishments and manufacturers of plasma derivatives. We based these recommendations upon current knowledge and advice from FDA’s Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC). All other recommendations involving CJD and vCJD in the 2002 guidance are unchanged.
Tests are being developed to detect CJD and vCJD infections in blood and plasma donors. However, until suitable donor screening tests become available, FDA is recommending interim preventive measures based on the available scientific data and the evolving state of knowledge regarding these diseases.
We expect that additional epidemiological information will become available as the epidemics of vCJD and Bovine Spongiform Encephalopathy (BSE) continue to evolve. We may update this guidance in the future, in light of developments in testing technology, epidemiological information, and the impact of these recommendations on the supply of blood and blood-derived products.
In this guidance, we recognize full Donor History Questionnaire (DHQ) Version No. 1.3 dated May 2008 (v.DHQ-1.3), prepared by the AABB Donor History Task Force, as an acceptable mechanism that is consistent with FDA requirements and recommendations for collecting donor history information.5 In this guidance, we also provide licensed blood establishments that collect blood and blood components intended for transfusion or for further manufacture with recommendations on how to report to FDA a manufacturing change consisting of the implementation of acceptable DHQ documents.
This guidance applies to Whole Blood and blood components intended for transfusion, and blood components intended for use in further manufacturing into injectable and non-injectable products, including recovered plasma, Source Leukocytes and Source Plasma, and plasma derivatives. Within this document, “donors” refers to donors of Whole Blood and blood components and “you” refers to blood collecting establishments or manufacturers of plasma derivatives.
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