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 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 Ellenberg, Susan S.
2. Active Control Equivalence Trials in Drug Development Temple, Robert J.
3. The Role of the Statistician on FDA Advisory Committees D'Agostino, Sr., Ralph
Discussant: O'Neill, Robert T.
List of speakers who are nonmembers: Temple, Robert J.