Regulatory Foundations, Ethics, and Law Program

Investigational Drugs and Devices (IND/IDE)

As defined by the Food and Drug Administration (FDA), an IND, or investigational new drug application, is a request for authorization from the FDA to administer an investigational drug or biological product to humans. An IDE, or investigational device exemption, allows an investigational device to be used in a clinical study to collect safety and effectiveness data required to support a premarket approval (PMA) application or a premarket notification [510(k)] submission to the FDA.

Many researchers make the mistake of not filing an IND or IDE when regulations dictate they must. When a researcher becomes a sponsor-investigator, it is imperative that they become aware of the specific obligations in their roles as both the investigator and sponsor of the study. This knowledge will help to ensure compliance with all applicable regulations in maintaining and conducting research under INDs/IDEs.

External Resources

     FDA Investigational New Drug (IND) Application

     FDA Investigational New Device (IDE) Application

     Duke University School of Medicine Office of Regulatory Affairs

IND/IDE Case Studies

A series of case studies examining the regulatory issues specific to sponsor-investigator initiated research studies.

Consultation

The Harvard Catalyst IND/IDE Consult Service focuses on providing assistance to researchers both during the early stages of research development and maintenance. Volunteer IND/IDE regulatory experts from Harvard University and partnering institutions offer expertise, resources, and shared experiences to assist sponsor-investigators in meeting regulatory requirements for their ongoing and/or new clinical and translational projects.

To request any of the documents on this page be made accessible please email communications@catalyst.harvard.edu.