Welcome to the Innovative Science Solutions Online FDA AdComm Toolbox. With millions of dollars at stake and only one shot to influence the outcome, you need ISS and our FDA AdComm ToolBox to help you prepare and put your best data forward. Here you will find tools and resources to help you better understand the FDA AdComm review process, prepare for an upcoming meeting, and to stay abreast of the latest updates from the FDA. 

Get Smart. The FDA AdComm review process is very stressful. Thankfully, ISS has developed a program that can be adjusted to fit any timeline, works across therapeutic categories, and ensures success every time:

Figure 1 - The ISS Program to Prepare for FDA AdComms

Explore the rest of our ToolBox to find more AdComm insights...

Click on the button below to download our overview of the FDA AdComm process and to understand our approach!

What is the impact of a negative AdComm? Download our analysis of negative FDA AdComms from the past 5 years and read what we found.

Advisory Committee Materials

• Rosters - click here to see all the current rosters for Drug, Medical Device, and Biologics committees.
• Calendar - click here to see FDA's advisory committee meeting calendar.
• Meeting Materials - click here to see recently updated advisory committee materials.
• Advisory Committee Updates - click here to receive advisory committee updates from FDA.

FDA Guidances

• FDA guidance on how the public can participate in the open public hearing (OPH) portion of an FDA AdComm (December 2010). Download it here.
• FDA guidance on how to develop, organize, and submit advisory committee briefing materials for public release and how to identify information that is exempt from public disclosure (August 2008). Download it here.
• FDA guidance on factors the FDA considers in deciding whether to refer a matter to an advisory committee for consideration (August 2008). Download it here.
• FDA guidance on public conduct during an FDA advisory committee meeting. Download it here.