To Meet or Not to Meet: Day 70 and Counting

Recent communications from CDRH indicate that impacts to resources from Reductions-In-Force are causing some Offices in CDRH to delay granting a request for a pre-submission (or Q-Submission) meeting until after written feedback is provided. In a pre-submission, the Sponsor can request written feedback only, but in most cases the Sponsor requests either an in-person or teleconference meeting, both of which are preceded by written feedback. The normal process is for FDA to schedule the meeting soon after receipt of the request in order to provide adequate time to coordinate schedules. Per the Q-Submission Guidance, these meetings are usually held 70-75 days after receipt of the submission. Written feedback is generally provided around day 70, or five days before a scheduled meeting, whichever is sooner.

We recently learned that at least one Office is responding to pre-submission requests stating that while it aims to provide written feedback within 70 days, the Office will not schedule a meeting until the Sponsor receives the written feedback and determines it would like a meeting to clarify any points in the feedback. (It is worth noting that a meeting will be automatically set at day 75 due to the database system’s programming, but this is not a real meeting date.)

On the surface, this is reasonable. If feedback is clear, there is no need for a meeting. In fact, the guidance document specifically says the Sponsor may cancel a meeting if they are satisfied with the written feedback. It is, of course, always easier to cancel a meeting than to schedule one, and our experience has shown that even scheduling a meeting two months in advance can at times prove challenging. The reality is that if the Sponsor is not allowed to formally request a meeting until after receipt of written feedback at day 70, it is not clear how long it could be until a meeting could be scheduled, given the challenges in doing so-but it would certainly be at least three, and likely more, months from the time of submission of the Q-Sub to the meeting with FDA. This can cause a significant delay for companies who are working towards aggressive timelines and need FDA feedback to move forward with next steps. Delayed meetings could also jeopardize the ability of companies to raise capital as FDA feedback can inform investor confidence and potentially impact funding. Most companies simply cannot afford to wait that long to resolve critical matters.

As Sponsors who have met with FDA know, meeting with the review team about its responses to a Q-Submission is incredibly helpful. For companies engaging with FDA for the first time, it allows the company and agency to begin building a relationship that will hopefully take them through a successful product authorization. Furthermore, there is always information that comes up during the course of the discussion that was not captured in the written feedback. These live interactions allow the Sponsor to better understand FDA’s position and how to work through any concerns expressed by the agency.

Pre-submissions are the best opportunity to align with CDRH. It is the time when Sponsors intensely prepare and make the most out of their meeting, whether by showcasing their expertise on their product and the field or asking clear, objective questions. CDRH’s delays in meeting with Sponsors will call into question the predictability of the review process and potentially exacerbate the availability of novel technology.