These template documents are meant to serve as a guide for preparation of regulatory submissions to the FDA. Additional regulatory tools and educational resources for academic researchers are available on the ReGARDD website.
Please note that all Duke-sponsored regulatory submissions to the FDA (or other federal regulatory agency) must be reviewed and submitted by the Duke Office of Regulatory Affairs and Quality (ORAQ). To request ORAQ review of your submission, please contact the ORAQ Regulatory Affairs Scientist assigned to the project. For assistance with a new project, please complete the Regulatory Affairs (RA) Service Request Form. Please refer to the Regulatory Service Request webpage for additional information on ORAQ review timelines.
When sending regulatory documents to ORAQ for review and submission, please provide the documents in Word format (vs. PDF) to facilitate review. You are encouraged to reach out to the ORAQ Regulatory Affairs Scientist assigned to the project for assistance with preparation of your submission or with any questions on the submission.
When preparing a new submission, we recommend downloading a new template to ensure you have the latest version.
Investigational Drug and Biologic Templates
INTERACT Meeting Templates (CBER)
Pre-IND and End-of-Phase (EOP) Meeting Templates
- Meeting Request Template
- Pre-IND Meeting Package Template
- EOP Meeting Package Template
- Meeting Package Cover Letter Template
Initial IND Submission Templates
- Sponsor Investigator Initial IND Template (simple version)
- Sponsor Investigator Initial IND Template (expanded version)
- Initial IND Submission Cover Letter Template
- Initial IND Submission Cover Letter with Exemption Rationale Template
Note: If you are planning to submit a commercial IND (i.e. an IND for a drug or biologic that you intend to commercialize in the future), please contact your assigned ORAQ Regulatory Affairs Scientist to discuss the appropriate format and template documents.
Investigor's Brochure Template
IND Maintenance Templates
- IND Maintenance Cover Letter Template
- IND Annual Report Template (single-study)
- IND Annual Report Template (multi-study)
- IND Safety Reporting Instruction Sheet
Transfer of IND Ownership Templates
- Sponsor Transfer Cover Letter Template
- Sponsor Acceptance Cover Letter for Sponsor-Investigators Template
- Sponsor Acceptance Cover Letter for Multi-Investigator Study Template
Orphan Drug Designation Templates
Investigational Device Templates
- Pre-Submission Instruction Sheet
- Pre-Submission Template (general)
- Pre-Submission Template (IVD)
- Pre-Submission Cover Letter Template
- Pre-Submission Meeting Minutes Template
Study Risk Determination Templates
Original IDE Templates
- Original IDE Template Instruction Sheet
- Original IDE Template
- Original IDE Cover Letter Template (CDRH)
- IDE Investigator Agreement Template