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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.

Completed upgrades to FDA conference rooms have enabled FDA to fully return to in-person meetings. As of January 22, 2024, CDER and CBER expanded in-person FTF industry meetings (with a hybrid component to allow maximum participation) 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 as of that date, regardless of the scheduled meeting date, were not 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.

Questions and Answers

  1. Q: During an in-person FTF meeting (with a hybrid component), who will be in attendance in-person and who will be virtual?
    A: During in-person FTF meetings (with a hybrid component), FDA staff who will be involved in the discussion of the questions are expected to attend in person.
     
  2. Q: Can anyone who is invited from FDA or industry attend in-person if they prefer?
    A: Yes. However, FDA recommends that for hybrid meetings “observers” (those not expected or likely to directly participate in the discussion) join the meeting virtually. This recommendation is intended to enable the best possible experience (sound and video) for those joining remotely to observe the meeting discussion.

    In addition, HHS policy requires that all visits involving Foreign Visitors to the White Oak Campus be approved in advance by an FDA or HHS Security Official.
     
  3. Q: Does the White Oak campus have the capacity to host large, in-person meetings?
    A: FDA White Oak campus has several large open rooms it utilizes for large public meetings. FDA has several other conference rooms that are set up specifically to handle formal meetings with industry for development programs. These rooms are sufficient in size to accommodate both FDA and industry attendees in-person who are expected to actively engage in the discussion.
     
  4. Q: Is there an option to have a strictly in-person meeting, with no hybrid component?
    A: All meetings have a hybrid component to enable attendees who may not be able to attend in-person to join. There are various reasons attendees may need to join virtually, including last minute emergencies that prevent travel or illness, or other travel limitations. Based on decades of experience with formal meetings, we anticipate that all meetings will have individuals who cannot (or do not need to) attend in person. Therefore, we expect that all in-person meetings will have a hybrid component to allow for these observers to attend virtually, without distracting from the discussion.
     
  5. Q: How does this differ from how industry meetings were held prior to 2020?
    A: Prior to 2020, options to join formal user fee meetings remotely via audio were available, but suffered from poor audio quality. Options to join remotely via audio and video using videoconference platforms (e.g., Adobe Connect, WebEx) were limited in their use and availability. Subsequently, during the pandemic, the information technology options for videoconferencing progressed rapidly in both availability and quality, enabling anyone with an internet connected device, a web camera, and microphone, to join a meeting with audio and video. It is now possible to easily and effectively offer a remote option for “observers” to join any meeting.

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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