When it comes to presenting at an FDA Advisory Committee meeting, there is no substitute for great data and clear messaging. But that isn’t enough. In addition to “what” you say – “how” you say it is important. The panel needs to believe that YOU believe what you’re saying. These tips are designed to help you DELIVER a highly effective presentation.
The FDA has just announced a new Draft Guidance entitled “Procedures for Meetings of the Medical Devices Advisory Committee.” Some significant procedural clarifications and modifications have been proposed that could have a broad impact on Sponsors. This article outlines key actions for Sponsors to mitigate potential risks associated with CDRH’s new approach.
There are few presentations as important as one delivered before an FDA Advisory Committee. After helping companies write nearly 150 FDA AdComm presentations, we at 3D Communications are more convinced than ever of our guiding principle. And that is, “An FDA Advisory Committee meeting is the wrong time for an original thought!” These tips are designed to help you write a highly effective presentation.
The article provides a brief history of the purpose and significance of advisory committee meetings, details how a sponsor can best prepare for these high-stakes events, and discusses how an FDA Advisory Committee Meeting can impact a companies’ development plans. Originally published in the November 2014 issue of TOPRA Regulatory Rapporteur.