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U.S. FDA Advisory Panel Meetings: Strategies to Maximize Success

Monday, June 4; 4 PM – 5 PM
Presenters:
Chris Mullin, Director of Product Development Strategy (NAMSA)
Richard Kotz, Principal Product Development Strategist (NAMSA and formerly with the FDA)

Description
Often, U.S. Food & Drug Administration (FDA) Advisory Panel meetings are the capstone to what is characteristically a long and arduous medical device development journey. While these meetings typically close with a voting session on a device’s approvability, recent real-world experiences demonstrate that achieving a favorable set of panel votes does not always guarantee swift FDA approval of the device under consideration.

This session will seek to provide global medical device manufacturers a better understanding of how to effectively prepare and plan for successful Advisory Panel meetings, and will include information on:

  • Understanding the role of FDA Advisory Panel meetings and how they contribute to the FDA’s decision-making
  • Examining the three key aspects of Advisory Panel meeting preparation:
    • Planning the appropriate clinical strategy
    • Executing successfully on the set strategy
    • Anticipating issues and concerns throughout the process
  • Exploring how to improve chances of FDA approval, including post-meeting initiatives
  • Exploring how Advisory Panel meeting takeaways can be used more broadly throughout the medical device continuum