Even though you, as a sponsor, can request any meeting format for the formal FDA meeting types, ultimately the FDA assesses each meeting request and determines whether the request should be granted and its appropriate format. You can find a summary of the response and scheduling time frame for each meeting in Summary of the different meeting management procedural goals table.
If a meeting is granted:
The FDA will notify the sponsor in writing regarding the meeting type and format. For Written Response Only (WRO) requests, the FDA’s letter will include the date that they intend to send their responses by. For face-to-face and other meeting formats, the FDA will schedule the meeting on the next available date within the scheduling time frame for each meeting type. If the meeting date is past the specified time frame for each meeting type, it is important to ensure that the date is within 14 calendar days of the requested day.
If a meeting is denied:
The FDA will notify the sponsor and include a letter explaining the reason for denial. It is important to note that the denial will be based on a substantive reason and not due to absence of a minor element in the request or package. These are examples of why a meeting request can be denied:
Premature for the stage of product development
Meeting package does not provide adequate information for a discussion
A follow up request to schedule a meeting will be considered a new request.
In case of rescheduling or cancelling a meeting:
At times, circumstances arise that may lead to rescheduling or cancelling of a formal FDA meeting. In the event that the meeting needs to be rescheduled, appropriate steps must be taken to ensure the meeting is rescheduled as soon as possible after the original date. Some examples of when a meeting can be rescheduled, as per the FDA guidance, include:
The FDA review team determines that the meeting package submitted is inadequate or needs additional information or needs further discussion with the sponsor and foresees the sponsor providing the additional information needed within the submission time frame
The sponsor provided insufficient time to the FDA review committee to look through the materials sent, despite submission within the specified time frames and appropriateness of context
If the sponsor sends additional questions to the FDA intended for discussion at the meeting, after the submission of the meeting package, which requires additional review time
The essential attendees are not available for the scheduled time and date
However, if the meeting is cancelled, the FDA will consider the follow up request to schedule a meeting as a new request. As per the FDA guidance, here are some examples of when a meeting can be cancelled:
If a meeting package is not received by the FDA within the specified time frame of the meeting type or is inadequate
If the sponsor determines that the preliminary FDA responses to their questions from the meeting package are sufficient and additional discussion is not needed
Thus, it’s important that both you, as the sponsor, and the FDA take reasonable steps to avoid rescheduling or cancelling of a meeting, unless necessary [1].
Note: Preliminary responses are communications that occur between the FDA and the sponsor prior to the requested meeting. They should not be considered as final until agreed upon by both the sponsor and the FDA. Usually, the FDA holds an internal meeting to review the meeting package. Following this, the FDA sends the preliminary responses within 5 calendar days before the meeting type (for Type B (EOP) and Type C). After this, the sponsor will have 3 days to decide whether a meeting is still needed. If the meeting is not needed, the sponsor will reach out to the FDA project manager for a request of cancellation. Following this, the FDA will consider whether it agrees with the cancellation or not [1].
It is highly encouraged to continue to hold a meeting with the FDA, if granted, to ensure that you and the Agency are completely aligned on all topics/recommendations.
For more information on how to respond to the FDA regarding the meeting request, please refer to the FDA guidance: Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (guidance for industry).