Investigational New Drug (IND)/ Investigational Device Exemption (IDE) Regulatory Program

The Investigational New Drug (IND)/Investigational Device Exemption (IDE) Regulatory Program provides guidance to clinical investigators, sponsors, and sponsor-investigators regarding the process to secure institutional approval to serve in the role of sponsor-investigator and submit an application for an IND or IDE to the FDA in accordance with the institutional policy on Investigator-held INDs/IDEs.

The policy does not apply to IND/IDE applications submitted to the FDA before the effective date, IND/IDE exempt studies, or emergency/compassionate use requests for single patients. Read answers to frequently asked questions.

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Johns Hopkins University "JHU" Investigator-held IND/IDE Review Procedures

An Investigator-held IND/IDE Review Procedures Overview flowchart is available.

Regulatory Resources

Investigational Drug, Biologic, and Device template documents are available to members of the Johns Hopkins research community, and are meant to serve as a guide for preparation of regulatory submissions to FDA. To improved the quality of regulatory submissions, increase efficiency and reduce delays in obtaining regulatory approval, and mitigate risk, we recommend partnering with a representative of the IND/IDE Regulatory Program prior to submission to FDA. Email us at [email protected], or schedule a consultation.

Education and Training