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In This Section
Investigational New Drug Application Process
This section provides comprehensive information for investigators that helps determine whether or not an IND is needed for the proposed study, the process of applying for an IND with the FDA, and the responsibilities of investigators who hold INDs. Additionally, the IND/IDE Support Office is a resource for investigators who would like to consult with us regarding study protocol design.
- IND Training Slide Decks
- IND Exemption Checklist
- FDA guidance regarding expanded access IND applications