The PDUFA VII and BsUFA III commitment letters provide an update to the definition of face-to-face formal meetings with Industry. This update clarifies that a face-to-face meeting “includes in-person meetings and virtual meetings on IT platforms that allow for both audio and visual communication.”¹ In other words, a face-to-face meeting between FDA and Industry is defined as either in-person or virtual with cameras on. FDA is in the process of updating our formal meetings guidance documents to reflect this revised definition. In the interim, we are highlighting this change on our public website to help reduce uncertainties on this point.

We note that while the revised face-to-face definition includes either in-person or virtual meetings, FDA is not currently holding in-person meetings, as communicated in our guidance Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications—Questions and Answers. This means face-to-face meetings will only be virtual at this time. Once FDA returns to in-person meetings, sponsors/applicants will be notified of that option for a face-to-face meeting.

As a reminder, sponsors/applicants may still request a teleconference. When a meeting is granted as a teleconference, regardless of the platform (e.g., Zoom) on which the teleconference is held, the meeting is audio only (i.e., no cameras on) and thus is not considered a face-to-face meeting.

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¹See footnote 9 in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, and footnote 2 in Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027.