The FDA ADCOM Meeting Checklist: Your Guide to an Organized Meeting

An FDA Advisory Committee (ADCOM) meeting is arguably the most important day of a product’s life cycle. To prepare for a successful meeting, you’ll need to carefully coordinate many moving parts. The last thing you want, is to forget a seemingly small detail that could derail an otherwise successful FDA ADCOM meeting.

This is our checklist of high priority (and often forgotten!) steps to make sure your “game day” runs smoothly.

 

FDA ADCOM Day High level Logistics (FDA, White Oak, Great Room):

  • Meeting Space at White Oak: There are only two meeting rooms available at FDA’s White Oak facility in addition to the FDA Advisory Committee “Great Room” where the meeting is held. Find out from your designated federal officer (DFO) if you can reserve one (or ideally both) of those rooms exclusively for your company. One room should be used to set up a “War Room.” The War Room is staffed with a team who watches the ADCOM meeting from a live feed and provides data and responses to ADCOM members’ questions that the Sponsor may not be able to answer quickly from the lectern. See the “materials list” below for helpful items to have available in a War Room. The second meeting room may be used as an additional meeting place for team members not critical to the War Room.
  • Meals: In the days leading up to your FDA ADCOM meeting, you will likely be preparing at a local hotel. Because there are no eating facilities at White Oak, you should arrange to have breakfast available at the hotel the morning of the ADCOM meeting. Yes, this means eating at 5:30am, but if you want a full breakfast, have it at the hotel. For lunch and coffee breaks during the ADCOM, you’ll need to work before your meeting date with Sodexo, the company that handles all of the food requests onsite. Since there is no formal lunch room, they will set up a table outside of the War Room.
  • Transportation: The easiest way to transport the team between the hotel and FDA is through pre-arranged shuttles. You can easily book them through a transportation company. Plan to arrive to White Oak before 7:00 AM the morning of the ADCOM meeting. The team will have to go through security, so you’ll want to leave plenty of time to deal with lines.
  • After the meeting concludes, you will need to vacate the War Room. If you want to debrief, arrange for this at an offsite hotel.

 

PowerPoint Presentation Slides:

  • All PowerPoint presentation slides (both core and Q&A) should be finalized the day before the ADCOM meeting.
  • The final slides will need to be printed for FDA (two slides per page/color) and the public (six slides per page/B&W). FDA will email you before your meeting with a recommended amount of copies. You’ll give these copies to the DFO about 30 to 45 minutes before the meeting starts.
  • Grab copies of FDA slides and materials once they’re put on the table outside of the Great Room, since copies of FDA’s slides are not reserved for you.
  • Make sure to handle all of the printing the day before the ADCOM meeting. It will take a few hours, so don’t underestimate the timing.
  • All of the slides that are shown at the ADCOM meeting become public, and FDA will post them on their website. This applies to both the core presentation and the Q&A slides. You must give two CDs of all slides shown to the public to the DFO directly after the meeting.

 

Equipment/Internet:

  • Work with FDA beforehand to ensure equipment can be set up and installed the day before the ADCOM meeting. We recommend reaching out to them as soon as the meeting is posted in the Federal Register to start making arrangements. All of the equipment has to go through its own security and scanning, and there is not enough time to do this the morning of your meeting.
  • Even though FDA has free public Internet, have backup Internet access ready for the War Room (i.e. individual MiFi hotspot devices).

 

Miscellaneous but Important Items:

  • All presenters and Q&A responders will be sitting in the Great Room all day. Make sure they have notepads, pens, and water at their seats.
  • Keep a big box in the War Room for all confidential trash, and take this with you upon departure.

 

Materials List:

  • Water
  • Pens
  • Pads
  • Printer/paper
  • Mifi devices (wireless Internet cards for war room)
  • Box for materials to shred
  • CDs (to give to FDA of slides shown)

 

Again, an FDA ADCOM meeting day is a high stakes, high priority meeting for any Sponsor. Working with this checklist early establishes a clear game plan for a smooth day, and allows the team to focus on more critical issues.

 

ABOUT THE AUTHOR

Mike Hilton is a seasoned project manager who helps 3D’s clients in both pharmaceuticals and medical devices prepare for FDA Advisory Committee meetings. He has nearly a decade of experience creating and managing PowerPoint slides for more than 100 mock rehearsals and nearly 50 Advisory Committee meetings. As an integral part of 3D’s technology team, Mike also assists clients with Q&A preparation. Connect with Mike on LinkedIn.