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.

Resources

• IND Training Slide Decks
  • Part 1 - IND Sponsor Responsibilities Training
  • Part 2 IND Sponsor Responsibilities Training
  • Part 3 - IND Sponsor Responsibilities Training
• IND Training Supplement
• Templates
  • IND Exemption Checklist
  • IRB Protocol Template
  • IND Application Template
  • General Cover Letter Template
  • IND Exemption Cover Letter Template
  • Initial IND Cover Letter Template
  • Annual Report Cover Letter Template
  • Annual Report Template
  • Withdrawal Cover Letter Template
• FDA guidance regarding expanded access IND applications