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