On December 8th 2022 the U.S. FDA (Food and Drug Administration) issued the Investigational New Drug Application Annual Reporting proposed rule that would replace its current investigational new drug (IND) annual reporting requirement with a new requirement: the FDA Development Safety Update Report (FDA DSUR).

FDA currently requires sponsors to submit an annual report with information about each ongoing study related to the IND, and those studies completed in the previous year. The proposed FDA DSUR regulation would require sponsors to submit a more comprehensive and informative report. It would ask for an overall safety analysis and a summary of cumulative safety information, among other requirements. These changes would help FDA and sponsors understand the safety profile of the investigational drug and, as appropriate, take actions to help protect research study participants.

In addition, the proposed FDA DSUR is more consistent with the annual safety reporting requirements in other countries and regions, as FDA intentionally made its format and content similar to the annual report that the International Council for Harmonisation (ICH) supports. This uniformity would make the reporting process more efficient for sponsors, who could submit similar reports to FDA and regulatory authorities in the European Union and other countries or regions. This action aligns with FDA’s broader goal to make international regulatory requirements more compatible, when appropriate.

Comments will be sought by the FDA on this draft guidance until 9 March 2023.

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