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Guidance on Blood Donor Suitability in Ebola Outbreaks
12/03/2015
 

Federal Register Notice: FDA is making available a draft document entitled Recommendations for Assessment of Blood Donor Suitability, Donor Deferral and Blood Product Management in Response to Ebola Virus; Draft Guidance for Industry. It provides blood establishments that collect blood and blood components for transfusion or further manufacture, including source plasma, with FDA recommendations for assessing blood donor suitability, donor deferral, and blood product management in the event that an outbreak of Ebola virus disease with widespread transmission is declared in at least one country. The draft guidance document applies primarily to Ebola virus (species Zaire ebolavirus), but recommendations are expected to apply to other viruses of the Ebola virus genus such as Sudan virus, Bundibugyo virus, and Taï Forest virus. The recommendations would apply to routine collection of blood and blood components for transfusion or further manufacture, including source plasma. To download this guidance, click here. To view this notice, click here.

 
 
 
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