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Guidance for industry : submission of documentation in applications for parametric release of human and veterinary drug products terminally sterilized by moist heat processes
2010
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Electronic and Book
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In vitro diagnostic (IVD) device studies, frequently asked questions
2010
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Assay migration studies for in vitro diagnostic devices
2009
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Draft guidance for industry and FDA staff : technical considerations for pen, jet, and related injectors intended for use with drugs and biological products
2009
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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 : animal models : essential elements to address efficacy under the animal rule
2009
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Guidance for industry : assay development for immunogenicity testing of therapeutic proteins
2009
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Guidance for industry : clinical pharmacology section of labeling for human prescription drug and biological products : content and format
2009
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Guidance for industry : Current Good Tissue Practice (CGTP) and additional requirements for manufacturers of human cells, tissues, and cellular and tissue based products (HCT/Ps).
2009
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Guidance for industry : drug-induced liver injury, premarketing clinical evaluation
2009
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