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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. 

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 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’s focus is 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 were upgraded, in phases, over the course of 2023 with new technology (e.g., noise-cancelling, boom-forming microphones, face/conversation tracking video cameras). Completed upgrades enable FDA to fully return to in-person meetings. 

Beginning January 22, 2024, CDER and CBER will expand in-person FTF industry meetings (with a hybrid component) to include all PDUFA, BsUFA, and OMUFA meeting types. If an in-person meeting is being requested, the sponsor should specify this in their request.  A final determination on the format will be made by the review division and communicated to the sponsor should the format be different than requested.  Existing meeting requests for the newly eligible meeting types received before January 22, 2024, 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.

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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