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USA: FDA Issues Revised ICH Risk-Benefit Submission Guidance

Thursday, July 27, 2017: The United States Food & Drug Administration (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.

 
 
 
 
 
 
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