Templates

The Office of Regulatory Support (ORS) can provide templates for many of the FDA submissions during the lifetime of an Investigational New Drug (IND) or Investigational Device Exemption (IDE).

Contact the Research Help Desk if you need assistance with drafting communications to the FDA or for templates for any of the following items:

Investigational New Drug Applications

  • Request for IND Exemption
  • Pre-IND meeting request and briefing package
  • IND Application
  • IND Annual Report
  • IND Withdrawal
  • IND Letter of Cross-Reference
  • Cover Letters
  • Investigator Brochures

Investigational Device Exemptions Applications

  • Cover Letter
  • Pre-IDE meeting request and briefing package
  • IDE Application
  • IDE Progress Report
  • Final Reports

Click here to email the Research Help Desk                    Click here to Request a Consultation

 

NIH Funding Acknowledgement ** Important ** All publications resulting from the utilization of CTSI resources are required to credit the CTSI grant by including the NIH FUNDING ACKNOWLEDGEMENT and must comply with the NIH Public Access Policy.