FDA to resume in-person formal meetings in February

Regulatory NewsRegulatory News | 30 January 2023 |  By 

After nearly three years of virtual meetings, the US Food and Drug Administration (FDA) on Monday announced it will resume scheduling in-person, face-to-face (FTF) formal meetings with drug and biologics sponsors beginning 13 February 2023.
The shift to virtual meetings took place in the early months of the COVID-19 pandemic, with FDA announcing via guidance that it would hold all CDER and CBER meetings with industry virtually for the duration of the public health emergency. (RELATED: FDA explains impact of COVID-19 on applications, formal meetings, Regulatory Focus 27 May 2020)
The announcement coincides with FDA’s return-to-office plan, which involves transitioning staff at its drug and biologics centers to a hybrid work environment early this year and follows the agency’s recent move to update its definition of “face-to-face” formal meetings with industry. (RELATED: This Week at FDA: Califf on Twitter, ‘face-to-face’ meetings, and more, Regulatory Focus 4 November 2022)
“This transition will enable FTF formal meetings between FDA and industry to be restarted. To avoid overcrowding in the conference rooms, FDA will focus on having only core participants with a primary speaking role in-person while others join virtually,” FDA said, noting that industry is encouraged to “follow this same pattern.”
As such, FDA said that “all in-person FTF formal meetings will have a hybrid component.”
The agency also said that it will be upgrading the conference rooms at its White Oak campus throughout the year to support the hybrid meetings, with new technology such as noise-cancelling, boom-forming microphones and face/conversation tracking cameras.
“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,” FDA said.
As more conference rooms become available, FDA said it will roll out in-person meetings to additional meeting types. Initially, only Type A, Biosimilar Biological Product Development (BPD) Type 1, and Type X meetings will be held in-person. The agency will also consider virtual-only face-to-face meeting requests for other meeting types.
In Phase 2 of the roll out, FDA said it will consider in-person Type A and Type B (milestone) BPD Type 1 and BPD Type 2, Type X and Type Y meetings, and in the final phase, all FTF formal meetings will be considered for in-person format.


© 2023 Regulatory Affairs Professionals Society.

Discover more of what matters to you