Please explore these curated materials including IND-related Templates, IDE-related Templates, FDA Resources for Drugs, and FDA Resources for Devices.
Templates & Resources
IND Related Templates
- FDA IND Checklist
- IND Application Template
- IND Cover Letter
- IND Amendment Cover Letter
- IND Amendment and Annual Report Table
- IND Protocol Amendment Template
- IND Information Amendment Template
- IND Annual Report Cover Letter
- IND Annual Report Template
- IND Final Report Cover Letter
- IND Final Report Template
- IND Safety Report Cover Letter
- IND Exemption Letter Internal Memo Template
- IND Exemption Letter Brief
- IND Exemption Letter Long
- Request for Pre-IND Meeting Template
- Pre-IND Briefing Packet Template
- IND Confirmation that it’s OK to Proceed
FDA Resources
Drugs
- Biological IND Submissions
- Investigator-Initiated INDs
- Center for Drug Evaluation & Research (CDER) Guidance Documents
- Center for Biologics Evaluation & Research (CBER) Guidance Documents
- Exploratory INDs (aka Phase 0)
- FAQs about the IND Application Process
- FAQs about the Pre-IND Meeting
- FDA Form 1571 (IND Application)
- FDA Form 1572 (Statement of Investigator)
- FDA Form 3454 (Certification of Financial Interests)
- FDA Form 3455 (Disclosure of Financial Interests)
- FDA Form 3674 (Certification of Compliance)
>> If above FDA Form 3674 (Certification of Compliance) link does not work, download the form here.
Devices
- FDA Device Advice
- IDE Amendments, Safety, and Annual Reports
- Center for Devices & Radiologic Health (CDRH) Guidance Documents
- Device Classification
- FAQs about IDEs
- FAQs about Medical Devices
- IDE Required Elements
- Sponsor’s Responsibilities for Significant Risk Device Studies
- Significant Risk and Non-significant Risk Device Studies