Preparation Is Key To FDA Panel Success, Consultants And Industry Reps Say
This article was originally published in The Gray Sheet
Executive Summary
Preparation is key to a successful FDA advisory committee review and can require such steps as creating a contingency plan for unexpected questions, staging mock panel hearings before the main event and double checking data points in panel briefing documents, consultants and industry reps said during a March 29-30 forum in Washington, D.C.