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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 and Biologic Templates

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Investigational Device Templates

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Education and Training

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