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MEMORANDUM

Recommendations Regarding License Amendments and Procedures for Gamma Irradiation of Blood Products July 1993

Download the Final Memorandum
Final
Docket Number:
FDA-2013-S-0613
Issued by:
Guidance Issuing Office
Center for Biologics Evaluation and Research

This memorandum transmits recommendations regarding license amendments and procedures pertinent to irradiated blood and blood products. Irradiation of these products is a practice which has developed over many years to reduce the risk of transfusion-­associated graft-versus-host disease in recipients at this complication.

Since labeling of blood and blood products as irradiated pertains to safety and intended use, irradiated and non-irradiated products are considered different products by the Center for Biologics Evaluation and Research. Recommendations are provided here regarding manufacturing and quality control procedures, labeling and other aspects of production and use of irradiated blood and blood products.

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All written comments should be identified with this document's docket number: FDA-2013-S-0613.

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