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Guidance Documents/Guidance-Document/Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final Guidance

Changes to an Approved Application: Biological Products: Human Blood and Blood Components Intended for Transfusion or for Further Manufacture: Final Guidance

Detailed guidance document from FDA and regulatory agencies.

Document Details

Guidance Document

December 1, 2014

August 22, 2019

Center for Biologics Evaluation and Research

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