Regulatory Focus™ > News Articles > FDA Preparing to Release Guidance on Leukocyte-Based Transfusion Products

FDA Preparing to Release Guidance on Leukocyte-Based Transfusion Products

Posted 24 September 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) is preparing to release a new guidance for industry regarding transfusion products containing leukocyte reductions.

In a pre-release notice of impending availability on 24 September, FDA said the guidance, Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion, provides recommendations for validation and quality control monitoring. In addition, the guidance is also intended to be used by licensed blood establishments submitting biologics license application supplements for leukocyte-reduced components, explained FDA.

Leukocyte reduction, or leukoreduction, is a process in which white blood cells-leukocytes-are removed from blood products during processing, which is thought to reduce the likelihood of adverse events in patients receiving the transfusion.

The guidance, when released, will finalize an earlier draft guidance document by the same name released in January 2011, which replaces a 1996 guidance on the same topic. FDA said it incorporated a number of changes into the final version of the guidance relative to the draft version, including the clarification of some performance qualification criteria, clarification of definitions and removing some recommendations for use.

The guidance is scheduled to be released on 25 September 2012.

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