FDA Issues Revised ICH Risk-Benefit Submission Guidance

The FDA issued a revised version of its ICH-developed guidance on completing the clinical overview section of the Common Technical Document, including more details on risk-benefit submissions.

The guidance, known as M4E(R2), lists what sponsors should consider when describing risks and benefits, but does not specify a particular industry approach for completing assessments.

An ICH working group said the section of the CTD weighing benefits and risks — section 2.5.6, which also includes information on therapeutic context — should succinctly describe the sponsor’s thought process, but not present new data.