So, you have just been granted a face-to-face (FTF) meeting with the FDA. Woohoo! You’re going to Bethesda! Don’t be too quick to make those plane and hotel reservations. This morning, the FDA published a clarification from the FDA, CDER, Small Business and Industry Assistance (SBIA) program in its INDUSTRY NEWS section titled FDA Describes Updated Definitions of Face‑to‑Face Formal Meetings (here).
The Agency will update necessary PDUFA and BsUFA webpages to reflect that aFTF meeting can include in‑person meetings as well as virtual meetings consistent with PDUFA VII and BsUFA III commitment letters. Apparently, there may have been some questions or confusion about the FTF designation. When you get the invitation, just tamper your excitement and be sure to find out whether you’ll have the privilege of making the trek to the Bethesda campus or whether you’ll be watching the FDA side of the event on the small screen.