FDA Redefines Face-to-Face Meetings to Include Virtual Option

The FDA is changing its definition of face-to-face meetings to clarify that they include both in-person meetings and virtual meetings on audio- and video-enabled platforms. But at the moment it won’t be holding in-person meetings.

“Face-to-face meetings will only be virtual at this time,” the FDA said in a notice posted yesterday, pointing to its COVID-19 guidance on formal meetings and user fee applications.

The FDA’s guidances on formal meetings will be updated to reflect this change. The updated definition implements commitments the agency made for the reauthorized Prescription Drug User Fee Amendments (PDUFA VII) and Biosimilar User Fee Amendments (BsUFA III).

The FDA said it will notify sponsors once it returns to in-person meetings.

Read the FDA’s updated definitions here: bit.ly/3fAt7e7. — Selma Khenissi