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Impact of FDA Advisory Committee Voting on FDA Approval Decisions for Drugs and Biologics

Time

Tue, Jun 17 7:15AM
T 36

Title

Impact of FDA Advisory Committee Voting on FDA Approval Decisions for Drugs and Biologics

Abstract Summary

Using committee meeting reports from 2002 to 2013, and computer analysis, committee voting was compared with FDA approval decisions. Committee support was defined as a majority vote of “Yes.” Committee rejection was defined as a majority vote of “No” or an “Equal” vote.

Poster Presenter

Regina Ballinger
BSN, MS, RN,
Senior Manager and Executive Editor,
Thomson Reuters
United States