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Center for Biologics Evaluation and Research (U.S.)
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PHS guideline on infectious disease issues in xenotransplantation.
Published 2001
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Guidance for industry : certain human cells, tissues and cellular and tissue-based products (HCT/Ps) recovered from donors who were tested for communicable diseases using pooled sp...
Published 2008
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Guidance for industry : characterization and qualification of cell substrates and other biological starting materials used in the production of viral vaccines for the prevention an...
Published 2006
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Guidance for industry : considerations for developmental toxicity studies for preventive and therapeutic vaccines for infectious disease indications.
Published 2006
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Guidance for industry : recommendations for obtaining a labeling claim for communicable disease donor screening tests using cadaveric blood speciments from donors of human cells, t...
Published 2004
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Center for Biologics Evaluation and Research (U.S.)
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