Revised Preventive Measures to Reduce the Possible Risk of Transmission of CJD and vCJD by Blood and Blood Products

Monoclonal Antibodies - From Concept to Approval

Recommendation

20/21 May 2025
Vienna, Austria

Monoclonal Antibodies - From Concept to Approval
With a workshop about the development of ADCs

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

"Measures to reduce the Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease" from 17 January 2013,
"FDA issues Amendment to 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" from 11 July 2012
"FDA Guideline to Reduce the Risk of Transmission of CJD and vCJD by Blood and Blood Products" from 16 June 2010

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:

III. EXPLANATION OF CURRENT VCJD RECOMMENDATIONS
IV. RECOMMENDATIONS FOR DONOR DEFERRAL
V. POST-DONATION INFORMATION: RECOMMENDATIONS FOR PRODUCT RETRIEVAL AND QUARANTINE, CONSIGNEE NOTIFICATION, AND BIOLOGICAL PRODUCT DEVIATION REPORTING
VI. RECOMMENDATIONS FOR RECIPIENT TRACING AND NOTIFICATION
VII. LABELING RECOMMENDATIONS
VIII. IMPLEMENTATION OF RECOMMENDATIONS
IX. THE IMPACT OF GEOGRAPHIC DONOR DEFERRALS THAT ARE MORE STRINGENT THAN THOSE RECOMMENDED BY THIS GUIDANCE
X. SOURCES OF ADDITIONAL INFORMATION

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".