이 기사의 번역을 준비하고 있습니다. 그동안 영어 원문을 임시로 표시합니다.
비즈니스 · 2001. 1. 31.1 분 읽기
Draft “Guidance for Industry: Pre-Storage Leukocyte Reduction of Whole Blood and Blood Components Intended for Transfusion;” Availability
로컬 자동 번역 · 원본 출처 언어
요약
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 The draft guidance document provides recommendations on manufacturing and quality assurance applicable to pre-storage leukocyte reduction of blood components intended for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 This draft guidance document describes manufacturing procedures and controls that should be in place and would supersede the FDA memorandum issued on May 29, 1996, entitled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."
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →