Overview
IND Sponsor-Investigators are expected to submit brief annual reports of the progress of the investigations conducted under their IND application within 60 days of the anniversary date that the application went into effect.
Submitting IND Annual and Final Reports to the FDA
- 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.
FDA Guidance and UCSF Templates
FDA Guidance
- Information to Include in an IND Annual Report external site (opens in a new window)
- FDA adopted the Guidance for Industry: E2F Development Safety Update Report (DSUR) (PDF - 272KB) external site (opens in a new window) which describes a common standard for periodic reporting on drugs under development among the ICH regions and is intended to meet the IND annual reporting requirements. To promote global harmonization, FDA will accept the DSUR to meet an IND application annual report requirements.
UCSF Templates
Annual Report
- IND Annual Report Cover Letter external site (opens in a new window)
- IND Annual Report Template external site (opens in a new window)
Final Report