IND/IDE Assistance Program

The IND/IDE Assistance Program has been established to assist investigators holding an IND or IDE at all stages of an investigation. Specifically, the IND/IDE assistance program will:

  • Assist in the determination if there is a requirement for the submission of an investigator-sponsored IND or IDE.

  • Provide education to investigators regarding the regulatory responsibilities as the sponsors of INDs or IDEs.

  • Provide guidance in the preparation and submission of sponsor-investigator IND or IDE requirements.

  • Provide regulatory assistance during FDA inspections of sponsor-investigator clinical trials.

The program may be accessed via email at

Please find the IND and IDE Decision Worksheets below.