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CDER IND/NDA Reviews Guidance, The Common Technical Document and Good Review Practice

CDER IND/NDA Reviews Guidance, The Common Technical Document and Good Review Practice. John K. Leighton, Ph.D., DABT CDER/FDA. Overview. Current IND/NDA review process FDA/ICH guidance Common Technical Document CDER Pharmacology Good Review Practice. Review Team. Project Managers

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Pivotal safety data - PowerPoint PPT Presentation

CDER IND/NDA Reviews Guidance, The Common Technical Document and Good Review Practice