IND/IDE

Mission and Purpose

The mission of the University of South Florida IND/IDE Assistance Program is to provide comprehensive regulatory support, guidance and education to Sponsor-Investigators who need to file an Investigational New Drug (IND) or Investigational Device Exemption (IDE) application for U.S. Food and Drug Administration (FDA)-regulated clinical research. The goal of the IND/IDE Assistance Program is to facilitate excellence in research by ensuring regulatory compliance in innovative research projects that utilize drug, biologics or medical devices.

Scope:

The USF IND/IDE Assistance Program is available to USF System faculty researchers and/or University start-up biotech companies or other companies seeking regulatory support, guidance or education related to the IND/IDE application process.

IND and IDE Regulatory Assistance Services:

The USF IND/IDE Assistance Program will provide regulatory guidance and assistance to Sponsor-Investigators seeking to conduct clinical research that requires advance approval from the FDA. Regulatory assistance offered includes services such as those listed below:

  • IND/IDE consultation, including determination of need for IND or IDE
  • IND and IDE application submission assistance. The IND/IDE Assistance Program will assist Sponsor-Investigators with completing their application or review an application prior to submission and answer any questions the Sponsor-Investigator might have.
  • Monitoring program: The IND/IDE Assistance Program offers a monitoring program to assist Sponsor-Investigators with the monitoring requirements set forth in the federal regulations.
  • The Program will assist with the maintenance requirements of INDs and IDEs, including submission of amendments, annual reports and safety reports.
  • Quality assurance program: The IND/IDE Assistance Program will, upon request of a Sponsor-Investigator, conduct an audit of a regulatory file for quality assurance/quality improvement purposes.

For questions regarding these services or inquiries regarding additional services with which we might be able to assist, please contact us by email or (813) 974-5638.