The formal FDA meetings will be chaired by an FDA staff member. It is important to note that no audio or visual recordings of the discussions at the meetings are allowed. Presentations are not needed as the topics of discussion have already been shared in the meeting package. However, if you plan on making a presentation, please discuss it with the FDA project manager in advance. Additionally, it is recommended that at the end of the meeting, either a representative from the FDA or from the sponsors summarize the key discussion points, agreements, and action items, to ensure mutual understanding.
You can find more detailed information and guidance (agendas, outlines, dos and don’ts, etc.) on conducting the formal FDA meetings in the respective sections of this playbook.