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  • Blood Product Guidance Amended to Reflect New Disease Transmission Risks

    The US Food and Drug Administration (FDA) has released new guidance detailing how sponsors should include additional warnings on their products to reduce the risk of the transmission of Creutzfeldt-Jakob Disease (CJD). FDA last released a guidance on the topic in 2010, which made recommendations for labeling plasma-derived products to reflect the risks of CJD, which is a form of transmissible spongiform encephalopathy (TSE) spread through prions.  In its 11 June F...