Federal Register
Notice: FDA is making available a document entitled Guidance for Industry: Biological Product Deviation Reporting for Blood and Plasma Establishments. The guidance provides blood and plasma establishments, including licensed blood establishments, unlicensed registered blood establishments, and transfusion services, with FDA's current thinking on biological product deviation reporting requirements, such as determining when a report is required, the timeframe for reporting, and how to submit the report. To download this guidance, click here. To view this notice, click here.