Changes Ahead: Prepare for New FDA Guidance on Annual IND Reporting

Are you ready for the IND (Investigational New Drug) annual reporting major changes? The FDA (Food and Drug Administration) has proposed a new guidance for the annual reporting of an IND that would replace the current guidance requirements.

The current requirement contains individual study information, typically including multiple documents in section 1.13 of the eCTD. These documents include brief summaries of the status of each ongoing study and of each study completed during the previous year. These summaries are required to include: (1) a brief description of available results of each study completed during the previous year and interim results of ongoing clinical investigations and (2) information on the number of subjects included in each study [1]. These procedures require the sponsor to submit an annual report providing an update on the progress of clinical investigations conducted under its IND. 

Comprehensive DSUR Reports bring Greater Attention to Safety Profiles 

The new proposal would require sponsors to submit a comprehensive and informative DSUR (Developmental Safety Update Report), which is a compilation of the annual report requirements into one document into section 1.13 of the eCTD. This new proposal is similar to the EMA ICH (International Council for Harmonisation) guideline E2F [2], that is specific to both the overall safety analysis and cumulative safety information, along with additional requirements [3]. This proposed guidance would provide greater attention into the safety profile of the investigational drug and protect the study participants. The new guidance would also be consistent with annual requirements in other countries, which in hope, would make the process more efficient and compatible for sponsors when submitting similar reports to other regulatory authorities.

Proposed Guidance: Creates Consistency Across Regions

Per the FDA, “due to clinical studies becoming increasing complex in their pathway, the DSUR would be able to provide a risk assessment, which would allow sponsors and the FDA to identify and manage potential risks to patients, thus, reducing exposure to patients to unnecessary risks.” [4]  The focal point of the proposed requirement is to effectively encompass the entire scope of a large-scale, international development programs for marketing in multiple countries and regions, as well as, to capture data from all finalized and continuing clinical investigations conducted on behalf of the sponsor anywhere in the world, including investigations not conducted under an IND.  The proposed guidance will require that a sponsor must submit the same annual FDA DSUR for each IND held by the sponsor for that drug.

Get Ready for Enhanced Transparency of All Clinical Investigations

It has been noted that, the proposed IND Annual Report guidance will require sponsors to provide all active and clinical investigations, inclusive of those on clinical hold, any that have not been terminated, and any instance where a study report has not been submitted but the investigation is completed. This is to provide transparency of all relevant investigations conducted on behalf of the sponsor. The reporting period would be the 12-month period during which information was obtained for the annual FDA DSUR and ending with the data lock point [5]. This period would run from the previous anniversary of the date the IND went into effect until 1 calendar day before the anniversary of the date the IND went into effect.

We encourage you to provide comments regarding this proposed guidance by March 09, 2023.
Please see more direct information from the FDA.

Helpful Links:

• Federal Register :: Investigational New Drug Application Annual Reporting

• https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-e2f-development-safety-update-report-step-5_en.pdf
• https://www.fda.gov/media/71255/download
• https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-reporting-annual-reports

References