Preparing Early for a Successful FDA Advisory Committee or Device Panel Meeting

May 18, 2016

Given the Food and Drug Administration’s (FDA) increased scrutiny of clinical and long‐term safety, the agency is calling for more public Advisory Committee hearings each year. Good data alone are no longer enough to win approval. In today’s environment, it is critical to prepare a clear, credible and engaging presentation and to start the preparation process early. You must ensure that your team is ready for the most difficult questions in order to sustain credibility and achieve a positive committee recommendation. Importantly, Sponsors need to understand the FDA’s guidance on panel review meetings and their implications so that they can anticipate likely panel questions well before NDA or PMA submission. In doing so, Sponsors can proactively engage with FDA early and consistently throughout the product development program. Most companies are ill‐equipped to prepare for a daunting FDA Advisory Committee or Device Panel meeting. With so much at risk in a single presentation, all stakeholders must mobilize and have a clear strategy when approaching FDA for market approval. This presentation will walk you through key aspects of FDA’s guidance and provide you with proven steps that will optimize your success before an FDA Advisory Committee meeting.

Learning Objectives:

Upon the presentation’s conclusion, you should be able to:

  • Understand the process leading up to an Advisory Committee or Device Panel meeting, for both the Sponsor and FDA
  • Understand all the essential steps necessary to be successful at an FDA Advisory Committee meeting
  • Identify key project activities that can be strengthened by incorporation of panel considerations
  • Staff a team of internal personnel and external advisors to properly prepare for an FDA Advisory Committee meeting
  • Strategize opportunities for improving the chances of success

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