This is a legal form that was released by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration on July 1, 2018 and used country-wide. Check the official instructions before completing and submitting the form.
Q: What is Form FDA 1571?
A: Form FDA 1571 is the application for Investigational New Drug (IND).
Q: What is an Investigational New Drug (IND) application?
A: An Investigational New Drug (IND) application is a request to the FDA for authorization to test an experimental drug in humans.
Q: Why is Form FDA 1571 used?
A: Form FDA 1571 is used to provide the necessary information to the FDA in order to obtain permission to conduct clinical trials of a new drug.
Q: What information is required in Form FDA 1571?
A: Form FDA 1571 requires information on the drug substance, drug product, manufacturing details, proposed clinical studies, and the qualifications and experience of the investigator.
Q: Who needs to submit Form FDA 1571?
A: Sponsors or researchers who intend to conduct clinical trials with a new drug need to submit Form FDA 1571 to the FDA.
Q: Is Form FDA 1571 mandatory?
A: Yes, Form FDA 1571 is mandatory for anyone seeking permission to conduct clinical trials with a new drug in the US.
Q: How long does it take for FDA to review Form FDA 1571?
A: The FDA aims to review and respond to Form FDA 1571 within 30 days of submission, but the timeline may vary depending on the complexity of the application.
Q: What happens after FDA approval of Form FDA 1571?
A: After FDA approval of Form FDA 1571, the sponsor or researcher can proceed with the planned clinical trials of the new drug.
Q: Can Form FDA 1571 be amended?
A: Yes, Form FDA 1571 can be amended if there are changes to the proposed clinical studies or other relevant information. Amendments should be submitted to the FDA for review and approval.
Q: What are the consequences of not submitting Form FDA 1571?
A: Failure to submit Form FDA 1571 or obtaining FDA approval before conducting clinical trials of a new drug may result in regulatory action or legal consequences.
Download a fillable version of Form FDA1571 by clicking the link below or browse more documents and templates provided by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration.