The proposed rule seeks to revise FDA’s regulations for IND annual reporting.  The proposed rule would modify the format and content of the IND annual report to be generally consistent with those of the annual DSUR standards devised by the ICH. The proposed harmonization would result in savings in labor costs for certain sponsors who may no longer have to prepare a different type of periodic safety report for submission to certain other countries or regions in which a drug might be studied.  Moreover, FDA would receive safety data on investigational new drugs that is more comprehensive, which would enhance our ability to oversee the progress and safety of clinical investigations.  Costs would arise from increased labor associated with preparing and submitting a periodic safety report that is more comprehensive to meet the proposed requirements. Costs to government would arise from increased FDA resources being used to review the more comprehensive report.

Regulatory Impact Analysis: Investigational New Drug Application Annual Reporting Regulatory Impact Analysis (PDF - 441KB)  

Federal Register: 87 FR 75551, December 9, 2022

Docket:  FDA-2020-N-0258