Pharmaceutical industry stakeholders urged the US Food and Drug Administration (FDA) to better align its investigational new drug application (IND) annual reporting proposal with the International Council’s for Harmonization’s (ICH) E2F guidance on development safety update report (DSUR), especially with regard to the cut-off date for submitting annual reports.
These comments are in response to FDA’s proposed rule issued in December 2022 outlining changes to the current annual reporting requirements under 21 CFR 312.22 for investigational new drug applications (INDs) to better harmonize the format and content for periodic safety reporting during clinical trials with the ICH E2F guideline, which was adopted in 2010.
FDA received 16 comments on the guideline from major industry groups such as the Pharmaceutical Research and Manufacturers of America (PhRMA) and the Consumer Healthcare Products Association (CHPA), as well as pharmaceutical companies, hospitals, and research centers. The deadline for commenting was 9 March…
