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FDA Considerations for the Development of Dried Plasma Products Intended for Transfusion

蒋千琴 12/23/2021 浏览 320 FDA 美国

标准简介

Considerations for the Development of Dried Plasma Products Intended for Transfusion [附网盘链接]由FDA于过去发布，适用于美国。

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Considerations for the Development of Dried Plasma Products Intended for Transfusion [附网盘链接]
Considerations for the Development of Dried Plasma Products Intended for Transfusion [附网盘链接](截图)

 

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标准部分原文

Considerations for the Development of Dried Plasma Products Intended for Transfusion Guidance for Industry This guidance represents the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff responsible for this guidance as listed on the title page. I. INTRODUCTION We, FDA, are providing recommendations intended to assist manufacturers, sponsors, and applicants developing dried plasma products intended for transfusion in order to facilitate the 1

availability of safe and effective dried plasma products in the United States (U.S.). This guidance provides considerations for the successful development and licensing of dried plasma products and for the approval of devices used to manufacture dried plasma. The guidance 2

includes recommendations on optimal sources of input plasma; manufacturing and product quality, including product characterization; packaging and reconstitution; clinical studies; and device submissions. This guidance finalizes the draft guidance of the same title dated October 2018. FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the FDA’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in FDA’s guidances means that something is suggested or recommended, but not required. II. BACKGROUND Plasma is a critical component of early transfusion therapy in the management of traumatic hemorrhage (Ref. 1). Plasma can replenish various coagulation proteins that are consumed during the coagulopathy that may accompany traumatic injury (Ref. 2). Because plasma 1

For the purposes of this guidance, “dried plasma” means dried (e.g., lyophilized, spray-dried) plasma that is intended for transfusion following reconstitution. 2

For the purposes of this guidance, “input plasma” describes plasma used as the starting material for the preparation of the dried plasma product or used as the input into a device intended for the preparation of a dried plasma product. Recommendations regarding use of Plasma (as defined in 21 CFR Part 640, Subpart D) or Source Plasma (as defined in 21 CFR 640, Subpart G) as input plasma appear in section III.A of this guidance.

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