Instructions for Form FDA1571 Investigational New Drug Application (Ind)

Form FDA1571 Investigational New Drug Application (Ind)

This document contains official instructions for Form FDA1571 , Investigational New Drug Application (Ind) - a form released and collected by the U.S. Department of Health and Human Services - U.S. Food and Drug Administration. An up-to-date fillable Form FDA1571 is available for download through this link.

FAQ

Q: What is Form FDA 1571?A: Form FDA 1571 is an application used to submit an Investigational New Drug (IND) application.

Q: What is an Investigational New Drug (IND) application?A: An Investigational New Drug (IND) application is a request for permission from the FDA to conduct clinical trials with an investigational new drug in humans.

Q: What is the purpose of Form FDA 1571?A: The purpose of Form FDA 1571 is to provide the FDA with the necessary information about the investigational new drug and the proposed clinical trials.

Q: Who needs to file Form FDA 1571?A: Sponsors or clinical investigators who want to conduct clinical trials with an investigational new drug in the United States need to file Form FDA 1571.

Q: What information is required in Form FDA 1571?A: Form FDA 1571 requires information on the investigational new drug, the proposed clinical trials, and the qualifications of the clinical investigators.

Q: What happens after submitting Form FDA 1571?A: After submitting Form FDA 1571, the FDA will review the application and determine whether to grant permission to proceed with the proposed clinical trials.

Q: Is it possible to amend Form FDA 1571?A: Yes, it is possible to submit amendments to Form FDA 1571 if there are changes to the investigational new drug or the proposed clinical trials.

Q: What happens if Form FDA 1571 is denied?A: If Form FDA 1571 is denied, the sponsor or clinical investigator may have the opportunity to address the FDA's concerns and reapply for permission to conduct the clinical trials.