FDA to align IND annual reporting requirements with wider world

9 December 2022

The US Food and Drug Administration (FDA) has issued the Investigational New Drug (IND) Application Annual Reporting proposed rule to replace the current regulations.

New requirements will see drugmakers forced to complete the Development Safety Update Report (FDA DSUR), comprising of more comprehensive information.

At present, the FDA 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.

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