Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding When Conventional Platelets Are Not Available or Their Use Is Not Practical; Guidance for Industry; Availability

摘要

The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of an immediate in effect guidance entitled "Alternative Procedures for the Manufacture of Cold-Stored Platelets Intended for the Treatment of Active Bleeding when Conventional Platelets Are Not Available or Their Use Is Not Practical." FDA is issuing this guidance to provide a notice of exceptions and alternatives to certain requirements in the biologics regulations regarding blood and blood components. This notice is being issued to respond to a public health need and address the urgent and immediate need for platelets for the treatment of active bleeding when conventional platelets are not available, or their use is not practical. In addition, the guidance document provides recommendations to blood establishments for the manufacture and labeling of cold-stored platelets (CSP).