Countdown to GuidanceFDA Bacterial Guidance October 2021
October 2021 is the FDA Guidance1 deadline to implement a bacterial risk control strategy to enhance the safety and availability of platelets.
Pathogen reduction is the ONLY strategy recommended by FDA Guidance that mitigates transfusion-transmitted-infection (TTI) risk beyond bacteria.
Cerus Webinar Replay: Patient Safety and FDA Platelet Bacterial Guidance Compliance with Dr. Richard Benjamin (Cerus Corporation)
Cerus Webinar Replay: A Software Model to Estimate the Cost and Shelf Life Implications of New Platelet Technologies with Dr. Laura Pizzi (Rutgers University)
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Refer to the package insert for more information.
1. Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion: Guidance for Industry. US FDA; Dec 2020.