Millions of dollars are riding on your FDA Advisory Committee meeting. Any misstep can affect approval likelihood and timing. Be prepared. Innovative Science Solutions (ISS) can help ensure a timely approval by providing an integrated approach to managing all aspects of an FDA Advisory Committee meeting for your product. ISS has over a decade of experience across therapeutic categories, a proven, long-standing relationship with the FDA, a state-of-the-art slide management system as well as the scientific and business acumen to navigate the complicated waters of the advisory committee process. We provide a one-stop solution for all the mission critical elements and deliver unmatched services.

Key FDA Advisory Committee Review Services  

• Strategy
• Message Development & Management
• Briefing Book
• Mock and Internal Rehearsals
• Meeting Logistics
• Speaker and Presentation Training
• Slide Development and Management
• Audio/Visual Management
• Q&A Preparation
• Open Public Hearing Management

Why ISS?

• Experience. ISS has over a decade of experience in developing regulatory strategies including support for FDA Advisory Committee meetings. We are involved in more FDA Advisory Committee meeting s per year than even the largest  pharmaceutical companies.  Click here for a case study.
• Regulatory & Scientific Acumen. ISS is a team of highly qualified regulatory, clinical, and communication with an understanding of the complex issues confronting drugs and medical devices. We have developed successful regulatory and clinical strategies across many different therapeutic categories, supporting clients in: oncology, pulmonology, neurology, reproductive health, cardiovascular health, diagnostics …and the list goes on! 
• Proprietary Slide Management Solution. ISS utilizes a proprietary, state-of-the-art slide management system, specifically designed and successfully used for FDA Advisory Committee meetings. We also provide the latest audio/visual equipment and support.

ISS has assembled a collection of FDA Advisory Committee resources for your convenience. We provide our own insights on how to best prepare for an FDA Advisory Committee meeting, learnings from past meetings, as well as important documents relevant upcoming meetings. Access our ToolBox and bookmark the page to stay up to date with everything related to FDA Advisory Committee meetings.

Are you anticipating an FDA Advisory Committee meeting? Or has your meeting date recently been confirmed? Need help?