FDA Guidance: Changes to an Approved Application: Biological Products: Human Blood and Blood Components, 12/14

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In December, 2014, the US FDA published this guidance for industry,ﾠChanges to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture.

This document provides manufacturers of licensed Whole Blood and blood components intended for transfusion, or for further manufacturer, including Source Plasma, with recommendations intended to assist in determining which reporting mechanism is appropriate for submission of changes to an approved Biological License Application (BLA).

Appendix D of this document contains a table showing the FDA’s reporting recommendations for changes associated with various types and uses of Blood Establishment Computer Software (BECS).