An FDA meeting is just the start. We help you document outcomes, align your strategy, and implement FDA’s feedback effectively—turning insights into action that strengthens submissions, speeds approvals, and builds lasting regulatory success.
An FDA meeting doesn’t end when the call or conference is over – in many ways, that’s just the beginning. What you do after the meeting is just as important as the meeting itself. Proper post-meeting follow-up ensures that the knowledge gained translates into concrete improvements in your regulatory approach. In this section, we outline the key steps you should take following an FDA meeting and how to effectively leverage the FDA’s feedback in your ongoing project plans. These practices will help solidify agreements made with FDA, maintain momentum, and demonstrate that you take FDA’s input seriously.
For most formal FDA meetings (e.g., Pre-Submission meetings, Formal Dispute meetings, etc.), FDA expects the sponsor to submit draft meeting minutes within 15 calendar days. Even if not explicitly required, it is good practice to document any significant meeting in writing. These minutes should summarize the discussion, including questions asked and answers given, as well as any conclusions or agreements.
Documenting meetings not only memorializes FDA’s feedback but also signals to the Agency that you are diligent. As one NIH guide states: “It is your responsibility to take notes and submit meeting minutes… within 15 days of the meeting.” Following this to the letter demonstrates professionalism.
Right after the meeting (the same day, if possible), gather your team for an internal debrief. Discuss what was learned and ensure everyone has a consistent understanding of FDA’s position. This is the time to candidly evaluate: Was the meeting outcome positive, negative, or mixed? What are the implications for our project?
If during the meeting you committed to send FDA more information (for example, a supplemental data analysis or protocol), do so as soon as possible. Ideally, respond within the timeframe discussed. When submitting, clearly label it as a follow-up to the meeting (with reference to the meeting and any meeting tracking number). In your cover letter or submission, recap the context: “As discussed in the Jan 10, 2025 Pre-Submission meeting (Meeting ID#123), attached please find the requested revised stability testing plan.” This helps FDA slot your follow-up properly with the meeting record.
Timely follow-up builds trust. It also keeps the momentum – if you wait too long, FDA might forget details or it could push your project into a slower lane. There’s also a psychological aspect: delivering what you promised by when you promised subtly shows FDA that you are a responsible sponsor, which can positively influence how they view your eventual submission.
Now comes the critical part: using FDA’s feedback to your advantage. Here’s how:
Just because the meeting is over doesn’t mean you can’t reach back out to FDA for clarification. If, when implementing their feedback, you encounter uncertainty, it’s often possible to ask a follow-up question. This could be done via email to the lead reviewer or project manager (for small clarifications), or via another Q-Submission if the question is substantial. FDA would rather you ask than misinterpret their guidance. For instance, “Following up on our meeting, we want to ensure we understood correctly: FDA wanted the new bench test performed per ASTM XYZ standard, correct?” They might quickly confirm by email. Having this in writing further protects you from misunderstandings.
Additionally, if FDA requested something and you find it infeasible or unnecessary upon further analysis, you can discuss it with them post-meeting. Possibly schedule a short call or propose an alternative via correspondence. They may be open to it, especially if you provide a rationale. The key is to handle this before you submit your final application, not during review, to avoid surprises.
Leverage the experience to improve your team’s competency. After one FDA meeting, do a lessons-learned internally: What went well? What could be better next time? Maybe your minutes could be streamlined, or perhaps you realized you should have involved a certain expert earlier. Apply these lessons to all future FDA communications. Over time, you build a strong institutional knowledge of dealing with FDA.
Also, consider maintaining a “Regulatory Contact Log” – a document that tracks all FDA interactions, major points, and outcomes. This becomes extremely useful as a reference, especially if team members change or when preparing for your next meeting. It’s effectively a knowledge base of your relationship with FDA.
Sometimes FDA feedback has value beyond just the specific submission discussed. For example, FDA might share insight into how they view a whole class of devices, or new expectations for clinical data that could affect other products in your pipeline. Make sure to disseminate such insights to other teams or product lines in your company. In this way, one meeting’s feedback can improve regulatory strategy across your organization. Smart companies keep a repository of FDA interactions and outcomes so everyone can learn from them, not just the team involved.
Effective post-meeting follow-up is about transforming FDA’s feedback into forward momentum. By promptly documenting the meeting, executing on action items, and weaving FDA’s guidance into your development and submissions, you maximize the benefit of that interaction. Sponsors who excel at follow-up often find subsequent dealings with FDA to be smoother – the Agency remembers that you listened and acted on their advice, creating a positive cycle of trust. Always remember, an FDA meeting is not a one-off event but part of an ongoing dialogue. Treating it as such – a conversation that continues through your follow-up actions – will significantly enhance your regulatory success. Our team places strong emphasis on this phase, assisting clients in interpreting and implementing FDA feedback thoroughly. After all, the true measure of a successful FDA meeting is seen in what happens next: quicker approvals, compliant products, and fewer surprises down the road, all made possible by leveraging the FDA’s feedback to its fullest.
