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Guidance for Clinical Investigators Sponsors and IRBs Investigational New Drug A

S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologics Evalua tion and Research CBER Center for Food Safety and Applied Nutrition CFSAN September 2013 ClinicalMedical

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Guidance for Clinical Investigators Sponsors and IRBs Investigational New Drug A






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