Helping researchers navigate clinical & translational research regulatory processes. Regulatory Foundations, Ethics, and Law Program

Investigational Drugs and Devices (IND/IDE)

Overview

Getting Started | Submission & Responsibilities | Regulations & Forms | Additional Education | Request Consultation | Collaborate

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.

The language in the Code of Federal Regulations and the Food and Drug Safety Act is difficult to interpret and often misunderstood. 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.

* A sponsor-investigator is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug or device is being administered, dispensed, or used. The obligations of a sponsor-investigator include those of both an investigator and a sponsor. For more information about responsibilities for Sponsor-Investigators, please see the Sponsor-Investigator Frequently Asked Questions.

Getting Started

Submission & Responsibilities

IND/IDE Application Submission and Review

Who can I contact at the FDA?

Where to send applications?

Regulations & Forms

FDA Regulations

FDA Forms

FDA Guidance

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Additional Education

Consultation

  • Request a Consult

    The Harvard Catalyst IND/IDE Consult Service focuses on providing assistance to researchers both during the early stages of research development and maintenance. The goal of offering this service is to help increase regulatory compliance and further development of innovative drugs, biologics, and medical devices, with guidance on how to use all available Harvard Catalyst resources. 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.

Collaborate

  • Harvard Catalyst IND/IDE Subcommittee
    The Harvard Catalyst IND/IDE Subcommittee includes IND/IDE compliance leaders as well as those new to the regulatory compliance arena who offer a fresh perspective and novel approaches. The subcommittee assists IRBs as well as Harvard faculty working under the FDA regulations of investigational new drugs and devices. Participation in the IND/IDE Subcommittee provides an opportunity to collaborate with and learn from area experts around this topic. Learn more about the committee's functions on the How We Work page.
  • Connect with IND/IDE Contacts at Participating Institutions via the Harvard Catalyst Regulatory Atlas.

Contacts

Emily Ouellette, JD
IND/IDE Subcommittee Co-Chair
QI Program Assistant Director, FDA and Regulatory Support
Partners HealthCare
Email

Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Email
617-432-7811

Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations
Email
617-432-5755

Hila Bernstein
Regulatory Affairs Officer
Email
617-432-1167

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The above materials has been developed or compiled by the Harvard Catalyst IND/IDE Subcommittee. Resources marked with an asterisk have been developed at Harvard affiliated institutions, and those without link to FDA and other external regulatory resources as noted.