Recommendations To Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components; Draft Guidance for Industry; Availability

概要

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled "Recommendations to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt Jakob Disease by Blood and Blood Components." The draft guidance provides blood establishments that collect blood and blood components with revised recommendations intended to reduce the possible risk of transmission of Creutzfeldt-Jakob disease (CJD) and variant Creutzfeldt-Jakob disease (vCJD) by blood and blood components. The recommendations in the draft guidance apply to the collection of Whole Blood and blood components intended for transfusion or for use in further manufacturing, including Source Plasma. The draft guidance replaces the document entitled "Amendment to `Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt- Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products,' " Draft Guidance for Industry, dated December 2017, and when finalized, will supersede the document entitled "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Cr