IND Submissions
- IND Checklist for IND Submission
- FDA Form 1571 - IND Application
- FDA Form 1572 - IND Investigator Statement
- FDA Form 1572 (Box 8) - Protocol Summary Template
- FDA Form 3454 - Certification: Financial Interests and Arrangements of Clinical Investigator
- FDA Form 3455 - Investigator Financial Interest Disclosure
- FDA Form 3674 - IND Certification of Compliance
- IND Application Template
- IND Cover Letter
- IND Protocol Template
- Request for Orphan Drug Determination
IND Amendments
Annual and Final Reports
- IND Annual Report Cover Letter
- IND Annual Report Template
- IND Final Report Cover Letter
- IND Final Report Template
Safety Reports
Useful Links
- 21 CFR 312
- Biological IND Submissions
- Center for Drug Evaluation & Research Guidance Documents
- Center for Biologics and Research Guidance Documents
- Content and Format of IND Applications
- Exploratory INDs (aka Phase 0)
- FAQs about the IND Application
- FAQs about the Pre-IND Meeting
- FDA Form 1571
- FDA Form 1572
- FDA Form 3454
- FDA Form 3455
- FDA Form 3674
- Investigational New Drug Applications
- UCSF Guidance for IND
Need assistance or have regulatory questions? Please contact CTSI Consultation Services