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Guidance for industry : cooperative manufacturing arrangements for licensed biologics
2008
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Electronic and Book
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Demonstration of comparability of human biological products, including therapeutic biotechnology-derived products
1996
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Guidance for industry and review staff : labeling for human prescription drug and biological products : determining established pharmacologic class for use in the highlights of prescribing information
2009
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Guidance for industry : considerations for allogeneic pancreatic islet cell products
2008
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Guidance for industry : indexing structured product labeling
2008
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Guidance for industry : integrated summary of effectiveness
2008
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Guidance for industry : providing regulatory submissions to the Center for Biologics Evaluation and Research (CBER) in electronic format, lot release protocols
2007
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Guidance for industry : labeling for human prescription drug and biological products, implementing the new content and format requirements
2006
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Emerging health care issues : follow-on biologic drug competition
2009
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Australia : follow-on biologics
by
White, Lisa J.
2007
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