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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John K. Leighton, Ph.D., DABT
Not replace standard assessment
Start dose selection
Acute toxicity testing
Electronic NDA submission
BiotechnologyFDA/ICH Guidance Topics