9/10 November 2021
This draft guidance is intended to amend the guidance entitled "Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob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 May 2010 (2010 CJD/vCJD guidance)(May 27, 2010),1 by revising the recommendations for labelling of plasma-derived products, including albumin and products containing plasma-derived albumin, to reflect current understanding of vCJD transmission through blood. When finalized, the 2010 CJD/vCJD guidance will be updated by incorporating the revised labelling recommendations. However, other recommendations in the 2010 CJD/vCJD guidance will continue to be valid as provided.
For further information please see "Draft Guidance for Industry: Amendment to “Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and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”.