Draft “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;” Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft 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 August 2001. The draft guidance document provides comprehensive current recommendations to all registered blood and plasma establishments for deferral of donors with possible exposure to the agent of vCJD. The new recommendations are intended to minimize the possible risk of vCJD transmission from blood products. When the draft guidance is finalized, the guidance document entitled "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and New Variant Creutzfeldt-Jakob Disease (nvCJD) by Blood and Blood Products" dated November 1999 will be superseded.