14/15 December 2023
In January 2016, the Food and Drug Administration's Center for Biologics Evaluation and Research (CBER) published the updated issue of the Guidance for Industry" Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products".
This document is part of a series of guidelines on that topic - please also see thew news
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.
The guideline document includes, amongst an introduction and some background about CJD and the regulatory history, the following chapters:
For more details please read the complete Guideline "Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products".