DIA 2022 Global Annual Meeting

Component Type: Session
Level: Basic

FDA and Industry joint dialogue session to discuss FDA and sponsor-specific best practices to ensure interactions with FDA are efficient, timely, and productive

Learning Objectives

Discuss FDA and industry's new PDUFA VII commitments regarding scientific dialogue between sponsors of applications and the FDA; Describe new thinking and ideas on interaction with the Agency will be explored in tandem with industry’s responsibility (per PDUFA VII) to collect sponsor specific best practices for meeting management.