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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 transitioned to a hybrid workplace, with staff returning to work at the White Oak campus (on-site) for a portion of their time. This transition has enabled in-person FTF formal meetings between FDA and industry to be restarted. To avoid overcrowding in the conference rooms, all in-person FTF formal meetings will have a hybrid component (virtual attendees in addition to in-person attendees). 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. To support hybrid meetings, FDA 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). As communicated previously, the availability of hybrid conference rooms initially limits the number of in-person meeting requests that can be granted. Key upgrades have now been completed for some additional rooms, allowing FDA to further expand the types of in-person meetings that can be held. Updates on FDA’s transition to in-person FTF formal meetings will be communicated in advance, including on this website.

Beginning June 12, 2023, CDER and CBER will expand in-person FTF industry meetings (with a hybrid component), to include requests for Type B End-of-Phase 2 (EOP2), along with the previously announced 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 meeting requests received before June 12, 2023, or meetings already scheduled regardless of the scheduled meeting date, will not be converted to the in-person format, to permit fair implementation of the transition.

CDER and CBER will continue to frequently monitor conference room upgrades, and as additional rooms are completed, we will continue the expansion until all formal meeting types that would qualify for FTF can be requested as in-person.

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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