Being awarded an FDA clinical meeting is an exciting indicator of success. Yet, the process and pressure to make it past the meeting can be intimidating. If you haven't participated in an FDA Clinical Meeting before here are few pointers to help you prepare.
Most Important, Be Prepared.
You will find the FDA folks are very well prepared. They will have studied your briefing documents sent earlier and understand them very well. You should be equally or even better informed.
For example, one clinical meeting I attended the first question asked was what was the chemical structure of our steroidal molecule. None of us knew this but for the FDA Director it was useful. We still did have a productive meeting but it shows you how detailed the questions can be.
Almost always, the FDA does not want a canned presentation for background information. They will have reviewed your briefing documents and will go directly to a discussion of your issues.
6 Quick Tips
- You should have already sent your important questions with the briefing package but you should also be prepared to discuss potential FDA answers with your own assessments of the best route to follow in the development process. They will be open to discussion.
- Have appropriate slides for elucidation available but usually only as a back-up.
- Mirror their collegial, professional and open atmosphere. The FDA specialists will be experts in their fields and will know the FDA requirements. They are open to any new approach that makes good sense.
- Designate someone as note taker. Review the FDA draft report by comparing it to your notes so that there is consistency. The FDA is quite cooperative for any justified changes.
- The time allotted for your meeting will be taken literally, it will start on time and end as scheduled whether you are finished or not. Do not use up your time with lengthy orations. Stick to your important information points.
- Allot time for security. Since it is a federal building, security is strict and can be drawn out. Arrive at front door well ahead of time. It is imperative to be in the meeting room ahead of time to set up and welcome the FDA members as they arrive. Blaming tardiness on security is not a welcome excuse.
There you have it. Nothing is too complicated, but preparing for the little things will make your meeting go smoother. Plan for the details and let the rest follow. If you have any questions please leave a comment or tweet us at @clinsmartCRO.