Guidance

Determining and Documenting The Need To File An IND/IDE Application

The Clinical Research Support Office, Program of IND Assistance(PIA) will provide assistance in determining the need to file an application. To consult with the IND specialist, please bring or send information on your proposal, any available literature documenting safe use in the intended population, or any available drug package insert. Summary guidance as to the need to submit an IND is provided on the FDA IND FAQs page. Assistance can also be provided to arrange an FDA pre-IND consultation if desired.
 

Overview of IND/IDE regulations

Title 21 of the federal register (21 CFR 312) contains the regulations regarding IND applications. The FDA Center for Drug Evaluation and Research IND Applications page provides links and information about the IND application process and applicable regulations. The information in the pages below provides additional explanations and links to assist investigators in navigating the sites, guidance and regulations. The IND specialist is available to help at all stages of the process.

21 CFR 312 specifies IND regulations for investigators and sponsors relevant to the conduct of FDA-regulated research.

Investigator-Sponsor Obligations

Investigators who are also acting as the sponsor, so-called, "sponsor-investigators", are held to both the responsibilities of sponsors and the responsibilities of investigators.

The sponsor-investigator is responsible for:

Additional instructions and links regarding execution of responsibilities are in the Conduct and Oversight section of this site.



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Contact Us: IND Specialist/Monitor 212-327-7408 or
Kimberly.Bazylewicz@rockefeller.edu