FDA Form 1571 is the official FDA form used to submit and maintain an Investigational New Drug (IND) application for human clinical studies in the United States.
The form identifies the sponsor, investigational product, study type, and key submission details that support FDA authorization to proceed. While the form itself is not an ethics review document, it links regulatory authorization to the clinical protocols and supporting data that must be ethically overseen. Accurate completion is essential for compliant IND activation and lawful study continuation. Errors or inconsistencies can delay regulatory processing and affect trial timelines.