FDA - Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products (Catapult's regulatory round-up - March)

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19 février 2024

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ELSIBI

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info:eu-repo/semantics/openAccess



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adelage, « FDA - Recommendations for Evaluating Donor Eligibility Using Individual Risk-Based Questions to Reduce the Risk of Human Immunodeficiency Virus Transmission by Blood and Blood Products (Catapult's regulatory round-up - March) », ELSIBI, ID : 10.58079/vv4z


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The Centre for Biologics Evaluation and Research (CBER) has issued a draft guidance to receive comments on revised recommendations for evaluating donor eligibility using individual risk-based questions. This draft guidance, when finalized will provide blood establishments that collect blood or blood components, including Source Plasma, with FDA’s revised donor deferral recommendations for individuals with increased risk for transmitting human immunodeficiency virus (HIV) infection. Published...

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