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비즈니스 · 2007. 7. 26.1 분 읽기
Draft Guidance for Industry: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells; Availability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: Cell Selection Devices for Point of Care Production of Minimally Manipulated Autologous Peripheral Blood Stem Cells (PBSCs)" dated July 2007. The draft guidance document discusses certain cell selection devices that minimally manipulate autologous PBSCs at the point of care for specific clinical indications, and the applicability of the requirements to such PBSCs. The guidance also discusses the submission of data intended to support approval of cell selection devices.
원본 출처 언어: Federal Register — Food and Drug Administration원문 발표 열기 →