Physician-Initiated Investigational New Drug (IND) or Device Exemption (IDE)
An Individual or group of individuals or medical center can be considered a sponsor for an investigation if they hold the IND or IDE. These studies are typically called Investigator Initiated Studies and may use an investigational drug or device or use an approved drug or device for investigational purposes.
The SEQuR office will consult with any individual, group which requires obtaining an IND or IDE prior to launching of the project. 207-396-8242
Do I need an IND/IDE to do my research?
IND/IDE Power Point Presentation
Link to UPenn IND Decision Tool
Guidance Documents
FDA Regulated Product - Adhering to Federal Regulations
Investigational New Drug (IND) Sponsor - Investigator Responsibilities
Physician/Investigator as Sponsor of an IDE - Non Significant Risk Device
Physician/Investigator as Sponsor of an IDE - Significant Risk Device