In a recent poll of Advisory Committee members, 81% said that testimony in the Open Public Hearing could influence their decision on the day of the Advisory Committee meeting. Yet, many pharmaceutical and device companies overlook this valuable opportunity when preparing for their Advisory Committee meetings. These 5 tips will help you plan for such a critical hour on a critical day.
In the scientific and regulatory community, effectively communicating data is one of the biggest challenges for a presenter. These tips help you put together a clear, coherent PowerPoint presentation that maximizes the impact of your data.
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The FDA has just announced a new Draft Guidance entitled “Procedures for Meetings of the Medical Devices Advisory Committee.”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.