IND Templates, Education & Useful Links

• IND Decision Tool
• IND Exemption Letter (example 1)
• IND Exemption Letter (example 2)
• Pre-IND Briefing Package
• Pre-IND Meeting Request
• INTERACT Meeting Briefing Package
• INTERACT Meeting Request - CBER
• INTERACT Meeting Request - CDER

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

• IND Amendment Cover Letter
• IND Protocol Amendment Template
• IND Transfer of Obligations

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 ResearchGo.