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FDA Advisory Committee Meetings

You can hear the fireworks, taste the champagne, all that’s left is an Advisory Committee Meeting with the Food and Drug Administration (FDA). Your success now depends on the flawless execution of your meeting strategy.

We have pioneered a unique marketing-based approach to FDA Advisory Committee Meetings to get you through this high-stakes interaction. Each Advisory Committee is different and has specific needs and concerns, and you must keep these in mind as you discuss your product.

After learning about key issues in your product’s history and identifying critical issues in your current application, ProPharma Group will create a strategy for your meeting that is predicated on concerns likely to be raised by the FDA Advisory Committee, and the data necessary to address them. With this strategy in place, we will help you to prepare a slide presentation that presents all information in a complete, understandable, and simple manner. Since most Committee members will review this information before the meeting, we must make it easy for them to understand why approval is rational. Next, we will make sure all participants are prepped for the meeting by conducting a rehearsal to train the speakers. Finally, we will attend the meeting with you, along with select Key Opinion Leaders (KOLs), providing data and presentations as needed during the meeting.

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