Preparing the Initial IND Application Components

An IND submission requires the following components:

1. IND Cover Letter
2. IND Application Template
3. FDA Form 1571 - IND Application (and FDA Form 1571 Instructions)
4. FDA Form 1572 - Statement of the IND Investigator) 
5. FDA Form 3454 - Certification: Financial Interests and Arrangements of Clinical Investigators
6. FDA Form 3455 - Investigator Financial Interest Disclosure
7. FDA Form 3674 - IND Certification of Compliance
8. IND Protocol Template
9. If applicable, Letter of Authorization (LOA) for the right of reference to the information contained in an existing IND application.

• IND Forms and Instructions
• Information for Investigators submitting INDs 

The following FDA documents provide an overview of the IND application process:

• Investigator-Initiated Investigational New Drug (IND) Applications, especially Regulatory and Administrative Components
• FAQs about the IND Application
• Content and Format of IND Applications
• Exploratory INDs (aka Phase 0)

For specific situations:

• Request for Orphan Drug Determination
• Biological IND Submissions