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Guidance on Blood Safety, Supply with H1N1 Pandemic

11/19/2009

Federal Register Notice: FDA is making available a Draft Guidance for Industry: Recommendations for the Assessment of Blood Donor Suitability, Blood Product Safety, and Preservation of the Blood Supply in Response to Pandemic (H1N1) 2009 Virus. It provides recommendations for assessing blood donor suitability and blood product safety and maintaining blood and blood product availability in response to pandemic (H1N1) 2009 virus. It is intended for establishments that manufacture whole blood and blood components intended for use in transfusion and blood components intended for further manufacture, including recovered plasma, source plasma and source leukocytes. To download this draft guidance, click here. To view this notice, click here.

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