NDAs and INDs must include subgroup analyses of gender, age and race -- proposed rule.
This article was originally published in The Tan Sheet
Executive Summary
NDAs AND INDs MUST INCLUDE ANALYSES OF GENDER, AGE AND RACIAL SUBGROUPS, according to an FDA proposed rule published in the Sept. 8 Federal Register. "The proposed rule would clearly define in the NDA format and content requirements the need to present effectiveness and safety data for important demographic subgroups, specifically gender, age and racial subgroups," the notice states.