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  1. Prescription Drug User Fee Amendments

Update on In-Person Face-to-Face Formal Meetings with FDA

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.”1 In other words, a face-to-face (FTF) meeting between FDA and industry is defined as either in-person or virtual with cameras on. While OMUFA does not have this formal definition, OMUFA meetings may also be conducted in-person or using the virtual meeting format allowing for both audio and visual communication. FDA is in the process of updating our formal meetings guidance documents to reflect this revised definition. In the interim, we are highlighting this change on our public website to help reduce uncertainties on this point.

In 2023, CDER and CBER staff will be transitioning to a hybrid workplace, with staff returning to work at the White Oak campus (on-site) for a portion of their time. 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 encourages industry to follow this same pattern. Therefore, all in-person FTF formal meetings will have a hybrid component (virtual attendees in addition to in-person attendees). To support hybrid meetings, White Oak conference rooms are being upgraded, in phases, over the course of 2023 with new technology (e.g., noise-cancelling, boom-forming microphones, face/conversation tracking video 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. Updates on FDA’s transition to in-person FTF formal meetings will be communicated in advance, including on this website.

Beginning February 13, 2023, due to the initially limited availability of upgraded conference rooms, CDER and CBER will restart in-person FTF industry meetings (with a hybrid component), starting with Type A, BPD Type 1, and Type X meeting requests. FTF meeting requests for other meeting types, if granted, will be held fully virtually (i.e., the in-person format will not be considered). Existing meetings received or scheduled before February 13, 2023, will not be converted to the in-person format to permit fair implementation of the transition.

CDER and CBER will be frequently monitoring conference room upgrades and as upgrades are completed, we will transition in phases such that all types of FTF formal meetings can be requested for in-person. For example, Phase 2 of this transition would permit the consideration of Type A and Type B (milestone), BPD Type 1 and BPD Type 2, Type X and Type Y FTF formal meetings to be considered for in-person scheduling. The final phase of this transition will enable any FTF formal meeting to be considered for in-person format.

If there are general questions for CDER meetings, please reach out to ONDExecOps@fda.hhs.gov. Questions for CBER meetings should be directed to industry.biologics@fda.hhs.gov.

1See footnote 9 in PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027, and footnote 2 in Biosimilar Biological Product Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027.

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