Draft “Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps);” Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps)" dated June 2002. The draft guidance document provides information that would assist manufacturers of human cellular and tissue-based products in minimizing the possible risk of transmission of CJD/vCJD by HCT/Ps through deferral of donors with possible exposure to the agents of CJD and vCJD. Because there is no readily available demographic information about the HCT/P donor population, FDA encourages establishments to submit with their comments study data concerning the effect that implementation of these recommendations could have on the HCT/P supply.