Draft “Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion;” Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a draft document entitled "Guidance for Industry: Pre- Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion." The draft guidance document provides recommendations on manufacturing and quality assurance applicable to pre-storage leukocyte reduction of blood components intended for transfusion. This draft guidance document describes manufacturing procedures and controls that should be in place and would supersede the FDA memorandum issued on May 29, 1996, entitled "Recommendations and Licensure Requirements for Leukocyte-Reduced Blood Products."