Overview
This page compiles links to the IND resources referenced on all other pages.
IND Background Information
Making IND Drug Determinations
- National Library of Medicine DailyMed database for approved indications
- UCSF Resource: IND Decision Tool
- FDA Guidance Investigational New Drug Applications (INDs) – Determining Whether Human Research Studies Can Be Conducted without an IND (especially pages 5-7)
- UCSF Sample IND exemption request letter for FDA
Pre-IND Meeting Guidance
FDA Guidance
- Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products Guidance for Industry (September 2023)
- Small Business and Industry Assistance: Frequently Asked Questions on the Pre-Investigational New Drug (IND) Meeting
- Pre-IND Consultation Contacts for Center for Drug Evaluation and Research (CDER)
UCSF Templates
IND Initial Application
FDA Guidance
- Investigator-Initiated Investigational New Drug (IND) Applications, especially Regulatory and Administrative Components
- FAQs about the IND Application
- Content and Format of IND Applications
- Exploratory INDs (aka Phase 0)
- IND Forms and Instructions
- Information for Investigators submitting INDs
- Request for Orphan Drug Determination
- Biological IND Submissions
Templates & Forms
- IND Cover Letter
- IND Application Template
- FDA Form 1571 - IND Application (and FDA Form 1571 Instructions)
- FDA Form 1572 - Statement of the IND Investigator (see sample Box 8 - Protocol Summary Template)
- FDA Form 3454 - Certification: Financial Interests and Arrangements of Clinical Investigators
- FDA Form 3455 - Investigator Financial Interest Disclosure
- FDA Form 3674 - IND Certification of Compliance
- IND Protocol Template An alternative template protocol can be found here from the NIH National Institute on Aging.
IND Protocol Amendments
FDA Guidance & Forms
- IND Protocol Amendments
- IND Information Amendments
- Form 1571 (PDF - 830KB) should accompany all amendments or reports.
- Form 3674 (PDF - 3MB) should be submitted for all new clinical trials.
- Form 1572 (PDF - 718KB) should be included if the amendment concerns change in application sponsor, addition of a new investigator, or transfer of IND obligations.
UCSF Templates
IND Safety Reports
FDA guidance documents
- Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
- Guidance for Industry and Investigators: Safety Reporting Requirements for INDs and BA/BE Studies (PDF - 227KB)
- Final Rule: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans
- Sponsor Responsibilities—Safety Reporting Requirements and Safety Assessment for IND and Bioavailability/Bioequivalence Studies Guidance for Industry
- Adverse Event Reporting to IRBs (January 2009)
All IND safety reports must be submitted:
- On a Form 3500A (if from clinical trials). See Instructions for completing Form 3500A
- accompanied by FDA Form 1571 - Investigational New Drug Application (IND)
- optional UCSF template: IND Safety Report Cover Letter
IND Annual Reporting
FDA Guidance & Forms
- Information to Include in an IND Annual Report
- Form 1571 (PDF - 830KB) should accompany all annual reports.
- Form 1572 (PDF - 718KB) should be included if the amendment concerns change in application sponsor or addition of a new investigator.
UCSF Templates
- Annual Report
- Final Report