FDA Policy/General

CDER/CBER Restarting In-Person Industry Meetings

CDER and CBER say that beginning 2/13 they will restart limited in-person, face-to-face industry meetings. It was just a matter of time for in-person industry meetings to restart after FDA commissioner Robert Califf announced late last year that FDA staff this year would be transitioning to a hybrid workplace at the White Oak, MD headquarters (see earlier story).

An FDA notice says that to avoid conference room overcrowding, the agency will employ a hybrid strategy too — only core industry and FDA participants with a primary speaking role will attend in-person while others join virtually. “To support hybrid meetings, White Oak conference rooms are being upgraded, in phases, over the course of 2023 with new technology (e.g., noise-canceling, boom-forming microphones, face/conversation tracking video cameras),” the notice says. “The availability of hybrid conference rooms will initially limit the number of in-person meeting requests that can be granted. The number of meetings that can be granted and held in-person with a hybrid component will increase as conference rooms are upgraded and staff transition over the course of 2023.”

Because of limited upgraded conference rooms, the first hybrid meeting requests will be for Type A, BPD Type 1, and Type X meetings. Type A meetings are those that are necessary for a stalled drug development program to proceed. A BPD Type 1 meeting is a meeting that is necessary for a stalled biosimilar product development program to proceed. And a Type X meeting is necessary for an otherwise stalled OTC monograph development program to proceed.

Face-to-face meeting requests for other meeting types will be considered under the current virtual meeting program. “Existing meetings received or scheduled before 2/13 will not be converted to the in-person format to permit fair implementation of the transition,” FDA says.

As more conference rooms are upgraded, FDA says it will allow other face-to-face (FTF) meeting requests (Type B, BPD Type 2, and Type Y meetings). “The final phase of this transition will enable any FTF formal meeting to be considered for in-person format,” it says.

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