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Laboratory and animal studies

FDA Role Throughout Pandemic Influenza Vaccine Development, Evaluation and Availability Activities Involving FDA Assistance, Research & Review. Pre-Post-IND. Pre-IND. Laboratory and animal studies. Development of manufacturing processes, pilot lots, assays. Development and

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Laboratory and animal studies

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  1. FDA Role Throughout Pandemic Influenza Vaccine Development, Evaluation and Availability Activities Involving FDA Assistance, Research & Review Pre-Post-IND Pre-IND Laboratory and animal studies Development of manufacturing processes, pilot lots, assays Development and selection of candidate vaccines and technologies Immunogen Identification (e.g. protein, strain) and proof of concept IND Phase 1 Human Studies Phase 3 100s – 1000s Licensing Phase 4 General Investigational Plan Phase 2 • Facility • Inspections • Safety • Efficacy • Lot release • Safety • Immunogenicity • Efficacy • Efficacy • Safety • Safety • Immunogenicity • (surrogate markers) • Dose Ranging Manufacturing & Facility Assessment Supplements (e.g. new facilities, population, strains) Possible EUA Pre EUA

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