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Sponsor(s): Sponsoring Section/Society: ASA BIOMETRICS

Session Time: 8:30-10:20 Wednesday

Estimated Audience Size: 400-500

A/V Request: Overhead and slides

Session Title: Statistics and Policy Setting at the Food and Drug Administration

Theme Session: Yes $\quad$ Applied Session: Yes

Organizer: Ellenberg, Susan S.  

Session Timing: 110 minutes total Opening Remarks by Chair - 5 or 0 minutes First Speaker - 30 minutes (or 25) Second Speaker - 30 minutes Third Speaker - 30 minutes Discussant - 10 minutes (or none) Floor Discussion - 10 minutes (or 5 or 15)

Chair: Cambell, Gregory  

1. Statistics, Statisticians and Policymaking at the FDA $\quad$ Ellenberg, Susan S.  

2. Active Control Equivalence Trials in Drug Development $\quad$ Temple, Robert J.  

3. The Role of the Statistician on FDA Advisory Committees $\quad$ D'Agostino, Sr., Ralph  

Discussant: O'Neill, Robert T.  

List of speakers who are nonmembers: Temple, Robert J.

David Scott