Module 5 Presentations

18/07/2024

IND Annual Reports (cont’d.)

These reports are submitted annually and should include the following information: ● Form FDA 1571 ● Individual study information ● Summary information (clinical & nonclinical) ● Updated General Investigational Plan ● Updated Investigator’s Brochure ● Significant protocol updates (Phase 1 protocol modifications not reported to the IND in an amendment) ● Summary of significant foreign marketing developments ● Log of outstanding regulatory business

The Organisation for Professionals in Regulatory Affairs

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IND Annual Reports (cont’d.)

FDA has adopted the Guidance for Industry entitled: E2F Development Safety Update Reports (DSUR) This guidance is intended to meet the IND Annual Reporting requirements and promote global harmonization. It describes a common standard for periodic reporting for drugs under development among the ICH regions. FDA will accept the DSUR to meet IND application Annual Report requirements.

The Organisation for Professionals in Regulatory Affairs

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