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USFDA Proposal: IND Annual Reports for More Comprehensive, Consistent with International Regulations

Earlier today (08-December-2022), the US Food and Drug Administration proposed a new annual reporting requirement for investigational new drugs (INDs) that would replace the current requirement with a new one: "FDA Development Safety Update Report (FDA DSUR)".

A sponsor must submit an annual report to the FDA detailing the status of every ongoing study related to the IND, as well as the results of the previous year's studies.

The proposed FDA DSUR regulation would require sponsors to submit a more comprehensive and detailed report that will include a summation of cumulative safety information and a comprehensive safety analysis. As a result of these changes, FDA and sponsors will have a better understanding of the investigational drug's safety profile and have the ability to take protective measures to help protect research study participants as appropriate.

Moreover, FDA's proposed DSUR is more consistent with other countries and regions safety reporting requirements because it intentionally mimics the format and content of the annual report that the International Council for Harmonisation (ICH) endorses.

As a result of this change, a uniform reporting process would simplify and streamline the reporting process for sponsors, who could submit similar reports to the FDA and regulatory agencies in various countries or regions of the world.

Overall the proposed annual FDA DSUR regulation, if finalized, would require an annual report that is more comprehensive and informative than the IND annual report currently required under FDA regulations.

Click this LINK to know more about the New proposal for Investigational New Drug Application Annual Reporting.


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