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Center for Biologics Evaluation and Research (U.S.)
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Guidance for industry : potency tests for cellular and gene therapy products.
Published 2008
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Guidance for industry : guidance for human somatic cell therapy and gene therapy.
Published 1998
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Guidance for FDA reviews and sponsors : content and review of chemistry, manufacturing, and control (CMC) information for human gene therapy investigational new drug applications (...
Published 2008
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Guidance for industry : validation of growth-based rapid microbiological methods for sterility testing of cellular and gene therapy products.
Published 2008
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Guidance for industry : gene therapy clinical trials, observing subjects for delayed adverse events.
Published 2006
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Guidance for industry : supplemental guidance on testing for replication competent retrovirus in reroviral vector based gene therapy products and during follow-up of patients in cl...
Published 2006
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