Saturday 28 May 2016

CBER - Blood and Blood Components

Listed below are the guidances that FDA CBER are planning to issue during the course of the year:

Relabeling of Apheresis Plasma Intended for Transfusion to Concurrent Plasma for Further Manufacture; Draft Guidance for Industry

Recommendations to Reduce the Risk of Transfusion-transmitted Chikungunya Virus (CHIKV); Draft Guidance for Industry

Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry (Revised Draft1)

Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products; Final Guidance for Industry

Labeling of Red Blood Cell Units with Historical Antigen Typing Results; Draft Guidance for Industry

For more details see: CBER

 Posted by Dr. Tim Sandle

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