Today’s pre-publication of the Federal Register contains a proposed rule (here) that will require the expansion of the current IND annual report. “Current § 312.33 requires sponsors that have an IND in effect to submit an annual report that must contain individual study information, which generally includes brief summaries of the status of each ongoing study and of each study completed during the previous year.”
The new proposed report, to be called the FDA Drug Safety Update Report (DSUR), will be much more comprehensive and include additional safety information, such as the requirement for an integrated overall safety analysis and a “summary of cumulative pertinent safety information.” The goal is obviously to obtain as much safety data as possible earlier in the process; as clinical studies are getting more complex, the Agency believes that the new report format and requirements will place more data before the FDA for it to, perhaps, see specific safety signals that might otherwise go undetected until later in the study. The Agency says, “[F]urthermore, because FDA intends that the DSUR be consistent with the format and content of submission of the DSUR supported by ICH, the annual reporting process for sponsors would be more efficient by supporting one format for submission to FDA and multiple regulatory authorities in the European Union (EU) and other countries and regions. This action is consistent with FDA’s overarching goal of fostering international harmonization of regulatory requirements to the extent appropriate and feasible.”
The document is sixty pages in length and spells out the new requirements as well as how firms will need to report the information. Have a look-see and you will have ninety days to provide comments on the proposed rule.