The FDA publishes updated Definitions of Face‑to‑Face Formal Meetings.
The Agency will update necessary PDUFA and BsUFA webpages to reflect that a face-to-face (FTF) meeting can include in‑person meetings as well as virtual (with cameras on) meetings consistent with PDUFA VII and BsUFA III commitment letters.
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.
While the revised face-to-face definition includes either in-person or virtual meetings, FDA is not currently holding in-person meetings.
Once FDA returns to in-person meetings, sponsors/applicants will be notified of that option for a face-to-face meeting.
doubts about: Formal Meetings & virtual meetings
- FDA is not currently holding in-person meetings this means face-to-face meetings will only be virtual at this time.
- Face-to-Face meeting between FDA and Industry is defined as either in-person or virtual with cameras on.
- sponsors/applicants may still request a teleconference.
- When a meeting is granted as a teleconference is audio only and is not considered a face-to-face meeting.
- When FDA returns to in-person meetings, sponsors/applicants will be notified of that option for a face-to-face meeting.
Learn More about Face-to-Face Format for Formal Meetings with FDA
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