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首页> 美国政府科技报告 >Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.
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Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion.

机译：工业指南：预存储白细胞减少全血和血液成分用于输血。

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We, FDA, are issuing this guidance document to provide you, blood establishments, with recommendations for pre-storage leukocyte reduction of Whole Blood and blood components intended for transfusion, including recommendations for validation and quality control monitoring of the leukocyte reduction process. We also provide information to licensed blood establishments for submitting biologics license application supplements to include leukocytes reduced components. This guidance applies to Whole Blood, Red Blood Cells, Plasma, and Platelets manufactured from Whole Blood or collected by automated methods. This guidance document finalizes the draft guidance of the same title dated January 2011 and supersedes the FDA memorandum issued on May 29, 1996, entitled Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products. We support the use of leukocytes reduced blood and blood components for specific indications (see section II.B) and seek to streamline the licensing procedure for leukocytes reduced blood components to assist blood establishments in making pre-storage leukocytes reduced blood components more widely available.

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