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Vaccine Pre-clinical Toxicology Testing

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Flowchart 4: Preparing an Investigational New Drug Application

Flowchart 4: Preparing an Investigational New Drug Application Vaccine discovery, background, rationale, immunogenicity information manufacturing COA Pre-clinical toxicology pre-IND Pre-IND Pre-IND meeting request manufacturing COA CMC Pre-Clinical Toxicology Pre-Clinical Toxicology Investigators' Brochure IND Vaccine manufacturing, controls, characterization, COA information Pre-clinical toxicology proposed protocol(s) Proposed Phase 1 clinical protocol(s) Written pre-IND meeting request Pre-IND meeting materials Pre-IND meeting with CBER CBER recommendations Finalize manufacturing process & lot release criteria COA & CMC section Modify Pre-Clinical Toxicology testing design Conduct Pre-Clinical Toxicology studies Modify Clinical Protocol design Prepare Investigators' Brochure IND Submission


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Last updated January 23, 2003 (cs)