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Guidance on Cell/Tissue Donor Eligibility

02/28/2007

Federal Register Notice: FDA is making available the Guidance for Industry: Eligibility Determination for Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) to assist establishments with making eligibility determinations for such products. The guidance finalizes a draft guidance of the same name dated 5/04. This guidance also finalizes the draft guidance, Guidance for Industry: Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt- Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/ Ps),'' dated 6/02. To download the guidance, click here. To view this notice, click here.

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