IND Templates, Education & Useful Links
- IND Decision Tool
- IND Exemption Letter (example 1)
- IND Exemption Letter (example 2)
- Pre-IND Briefing Packet
- Pre-IND Meeting Request
IND Submissions
- FDA IND Application
- FDA Form 1571 - IND Application and Instructions (not optimized for chrome)
- FDA Form 1572 - IND Investigator Statement and Instructions
- FDA Form 1572 (Box 8) - Protocol Summary Template
- UCLA Form FDA 1572 SOP
- FDA Form 3454 - Financial Interest and Arrangement
- FDA Form 3455 - Investigator Financial Interest Disclosure
- FDA Form 3674 - IND Certification of Compliance
- IND Application Template (approved drugs)
- IND Application Template (expanded)
- IND Cover Letter
- UCLA Protocol Template
- Request for Orphan Drug Determination
Expanded Access/Compassionate Use
- Single Patient IND
- Expanded Access IND Submission
- Form 3926 (Individual Patient Expanded Access IND)
- Form 3926 Instructions
- UCLA OHRPP Guidance - Emergency Use of a Test Article
IND Amendments
Annual and Final Reports
- IND Annual Report Cover Letter (CDER)
- IND Annual Report Cover Letter (CBER)
- IND Annual Report Template
- IND Final Report Cover Letter
- IND Final Report Template
Safety Reports
- IND Safety Report Cover Letter
- IND Safety Report and Instructions (not optimized for chrome)
- Safety Reporting Guidance
Useful Links
- 21 CFR 312
- Biological IND Submissions
- Center for Drug Evaluation & Research Guidance Documents (CDER)
- Center for Biologics Evaluation and Research Guidance Documents (CBER)
- 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
- Mobile Medical Apps
- UCLA Guidance for IND
Need assistance or have regulatory questions? Please contact the CTSI Office of FDA Affairs.