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Guidance Issuing OfficeCenter 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.
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
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-2013-S-0613.