Online Program

What Role Does a Statistician Play in an FDA Advisory Committee Meeting? (302448)

*Sue-Jane Wang, US Food and Drug Administration 

Keywords: Advisory committee meeting, regulatory statistician

U.S. Food and Drug Administration (US FDA) Advisory Committee meeting is a public hearing meeting. It is mostly designed to openly discuss and solicit from expert opinions on whether an investigational drug as a new molecular entity has demonstrated substantial evidence on efficacy and safety. The voting to the thoughtful prepared questions relating to efficacy and/or safety of the investigational drug, then, takes place toward the end of the AC meeting. The results of the voting are meant to facilitate ultimate regulatory recommendation on the approvability of the investigational drug.

In this presentation, I will relay my role as a regulatory statistician in an FDA advisory committee meeting setting. In this role, I’d share my experience as a regulatory statistical reviewer, as a regulatory expert statistician or as a regulatory supervisory statistician to facilitate the discussion at the US FDA AC meeting and for the AC members to form and opine their expert opinions. I plan to articulate these roles with use of publicly available resources.

*This abstract reflects the views of the author and should not be construed to represent the views or policies of the U.S. Food and Drug Administration.