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GUIDANCE DOCUMENT

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of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry" Draft Guidance for Industry December 2017

Draft

Not for implementation. Contains non-binding recommendations.

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; Guidance for Industry"

Docket Number:
FDA-2012-D-0307
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This guidance, when finalized, will amend the document entitled “Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Guidance for Industry” updated January 2016 (the “2016 vCJD Guidance”) (Ref. 1). The guidance provides revised recommendations intended to reduce the possible risk of transmission of variant Creutzfeldt-Jakob Disease (vCJD) by blood and blood products by: (1) revising and removing certain recommended deferrals for geographic risk of bovine spongiform encephalopathy (BSE) exposure; and (2) recommending deferral for individuals with a history of blood transfusion in Ireland from 1980 to the present.


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Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2012-D-0307.

Questions?

Contact Point
Office of Communication, Outreach and Development (OCOD)
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Food and Drug Administration
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