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During the last 10 years, the FDA published several guidelines adressing the risk of Creutzfeld-Jakob Disease and variant Creutzfeld-Jakob Diseses e.g. - “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” (1999),
- the “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” (2002)
- and a draft guidance entitled “Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to ‘Guidance for Industry: Revised Preventive Measures to Reduce the Possible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 (2006)’.
End of May, the FDA published the latest version of the "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". The monitored epidemiological data and the current scientific data necessitates to amend the 2002 guidance by: a) finalizing the donor deferral recommendation from the 2006 draft guidance (for donors who have received a transfusion of blood or blood components in France since 1980);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. Based on the knoledge of FDA's Transmissible Spongiform Encephalopathies Advisory Committee (TSEAC), this guideline will give 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. More details can be found here. Author:
Axel H Schroeder
On behalf of the European Compliance Academy (ECA)
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