Preparing the Initial IND Application Components

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Overview

The Sponsor-Investigator submits an IND Application to FDA that includes the components listed here.

IND Submission 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) (see sample Box 8 - Protocol Summary Template)
  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

FDA Guidance

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

For specific situations: