|Helping researchers navigate clinical & translational research regulatory processes.||Regulatory Foundations, Ethics, and Law Program|
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.
Gene Therapy Research
IND Safety Reporting for FDA
Monitoring and Audits
Preparing for an FDA IRB Inspection (FDA)
Information about preparing for an FDA Institutional Review Board inspection, including: what to expect on inspection day, pre- and post-inspection processes, common deficiencies, and points to consider.
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.
Emily Ouellette, JD
IND/IDE Subcommittee Co-Chair
QI Program Assistant Director, FDA and Regulatory Support
Sabune Winkler, JD
Director, Regulatory Foundations, Ethics, and Law Program
Aaron Kirby, MSc
Associate Director, Regulatory Affairs Operations
Regulatory Affairs Officer
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.