Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Ho
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Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Ho

S Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research CDER Center for Biologics Evaluation and Research CBER October 2000 User Fees Revision 1 Guidance for Industry Submitting and Reviewing Com

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Guidance for Industry Submitting and Reviewing Complete Responses to Clinical Ho




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