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Avoiding Common Mistakes in FDA Meetings

Common Mistakes in FDA Meetings and How to Avoid Them

FDA meetings are pivotal but easy to mishandle. Learn the top mistakes sponsors make—from poor preparation to unclear communication—and practical strategies to avoid them, ensuring productive, trust-building interactions with regulators.

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A meeting with the FDA is a high-value opportunity – but it can also backfire if not handled correctly. Companies, especially first-timers, often stumble in ways that undermine the effectiveness of FDA interactions. In this section, we highlight common mistakes sponsors make in FDA meetings (whether Pre-Submission meetings, advisory panels, or others) and provide tips on how to avoid them. By being aware of these pitfalls, you can ensure your FDA meetings are productive, professional, and move your project forward.

Top 6 Common Mistakes (and How to Avoid Them)

Lack of Preparation Walking into an FDA meeting without a detailed plan is a recipe for disaster. Some assume the meeting will be a casual chat or that FDA will guide the conversation. In reality, without a clear agenda and thorough prep, the discussion can meander and leave important questions unanswered. Avoidance Strategy: Prepare diligently. Define your objectives for the meeting and share an agenda or question list with FDA in advance. Internally, rehearse your presentation or Q&A. Anticipate FDA’s questions by reviewing your submission or proposal critically beforehand. The more scenario planning you do, the less likely you’ll be caught off guard.
Inadequate Data or Documentation Another common error is presenting incomplete, incorrect, or disorganized information to the FDA. This might be as simple as missing data tables in your slides or as serious as not having supporting evidence for claims you make. Without clear data, FDA cannot give useful feedback – or worse, they might get the impression you haven’t done your homework. Avoidance Strategy: Ensure all documentation provided is accurate and thorough. If you’re discussing a study, have a summary of results ready and consider sending a brief report ahead of time. Use visual aids like graphs or tables to make information digestible. Double-check any numbers or statements for accuracy – inconsistencies will erode FDA’s confidence.
Miscommunication or Lack of Clarity Even if you have the right data, how you communicate matters. Using heavy technical jargon with no explanation, giving long-winded answers that don’t address the question, or talking in hypotheticals rather than specifics can all lead to misunderstandings. One prevalent mistake is not actively listening to FDA’s remarks – as a result, sponsors sometimes answer the wrong question or miss the main point. Avoidance Strategy: Communicate clearly and succinctly. Tailor your language to the audience; FDA scientists are experts, but if your product is extremely novel, lay a foundation before delving into details. When responding to FDA questions, directly address the question first, then provide context as needed. Check in by asking, “Does that answer your question, or would more detail be helpful?” Miscommunication can also be avoided by summarizing key points: for example, “So, to recap, our device uses X technology and the main safety concern we’re addressing is Y.” Finally, encourage FDA to clarify anything unclear – sometimes just asking “Would it help if I re-explain any part of our results?” can prompt them to speak up about confusion.
Not Defining Objectives Clearly Going into a meeting without clear goals is a mistake that often manifests as a scattered discussion. If you haven’t internally agreed on what you need from the FDA (specific feedback, a decision on a testing plan, etc.), you may walk out with lots of general commentary but none of the concrete answers you sought. Avoidance Strategy: Set and share clear objectives. Before the meeting, pinpoint the top decisions or insights you need. For instance: “Confirm the regulatory classification (II vs III)” or “Get FDA’s perspective on the proposed clinical trial endpoints.” Communicate these to FDA in your meeting request or agenda. This focuses the meeting on outcomes. During the meeting, if conversation drifts, you can steer it back: “We appreciate that input. To ensure we meet our objectives, could we return to the question of …” Having well-defined goals keeps everyone on the same page.
Including the Wrong People FDA meetings can suffer from the wrong mix of attendees. A common mistake is bringing senior executives who have authority but lack technical knowledge, thinking their presence will add weight. In reality, if those executives cannot answer detailed questions, it wastes precious meeting time. On the other hand, failing to include key experts (clinical, statistical, etc.) who can address specific issues is equally problematic. Avoidance Strategy: Be strategic in choosing attendees. Limit participants to those who have a direct role or expertise relevant to the agenda. As one source notes, only include people “working on the development of the specific [product]” who can discuss the technical issues effectively. Your regulatory lead should definitely be there to manage the meeting, as well as subject matter experts for each anticipated topic (e.g., your QA/validation head if manufacturing is on the agenda). If higher management wants to listen in, they can – but they should let the experts do the talking. Ensure everyone present has a defined role (presenter, question responder, note taker, etc.). Importantly, if someone on your team has never been in an FDA meeting before, pair them with a mentor or consultant; or consider having an experienced consultant join as a co-representative. This avoids novice mistakes due to inexperience.
Failure to Follow Up The meeting itself is only as good as the actions afterward. A surprisingly common mistake is failing to capture what was said and not following up on agreed tasks. For example, FDA might ask for additional data in a Pre-Sub meeting, and the company nods along but then delays sending it or omits it in the meeting minutes. This can erode trust and nullify the meeting’s usefulness. Avoidance Strategy: Follow-up diligently. Assign someone to take detailed notes during the meeting. Within 15 days, submit official meeting minutes if required (as is the case for Pre-Subs), and ensure they accurately reflect any FDA feedback or agreements. Create an internal action item list immediately: what questions need further answers, what data to send FDA, any process commitments (like providing draft protocols for FDA to review). Then, execute on those items on the agreed timeline. If FDA expects a response in 2 weeks, meet that deadline or inform them of any slight delays with a valid reason. By promptly following up, you show FDA that you are responsive and reliable, which bodes well for future interactions.

Bonus Mistake to Avoid: Adopting an Adversarial Stance

While not a single misstep, a general attitude mistake is treating the FDA as an opponent. Some sponsors come into meetings overly defensive, trying to “win” arguments or even hiding information for fear of negative reactions. This approach usually backfires, creating tension and distrust. FDA meetings are not interrogations; they are meant to be collaborative. Avoidance Strategy: Adopt a cooperative mindset. Treat FDA reviewers as partners in getting a safe, effective device to patients. Acknowledge their concerns as valid perspectives, even if you need to provide additional info to address them. If you disagree, do so respectfully with data and logic, not emotion. Never lie or obfuscate – if you don’t know, say so and commit to finding out. Building a rapport based on honesty can turn even a challenging meeting into a productive session. As one guideline emphasizes, involve the FDA “as a team player” and don’t act like you know more than the regulators – humility and openness go a long way in these meetings.

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Conclusion

FDA meetings can certainly be challenging, but avoiding these common pitfalls will significantly improve your outcomes. The recipe for success is straightforward: prepare well, communicate clearly, bring the right people, and follow through. By learning from others’ mistakes (and a few of our own hard-earned lessons), you can ensure each FDA interaction builds your credibility and advances your project. Our consulting team routinely coaches clients on FDA meeting etiquette and strategy – helping them sidestep these errors. With the right approach, even a high-pressure FDA meeting becomes an opportunity to shine and move one step closer to regulatory approval.

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