Preparing the Initial IND Application Components

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

IND Forms and Instructions

FDA Guidance

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

For specific situations: