Across the Table from the FDA: How to Prepare for Successful Regulatory Interactions

In the medical product development process, meeting with the FDA is a major milestone, signaling that a development program has reached an important stage. However, these meetings can also feel daunting. What should you expect? How should you prepare? And how can you make the most of your limited time with the FDA?

Here, we take a look at what to expect and how to approach FDA meetings as well as important lessons for sponsors.

What to expect at an FDA meeting

Most FDA meetings last about one hour and may be held in person or virtually. For in-person meetings, you should arrive at the designated building early enough for your entire group to clear security. Yes, there is a security screening process, much like at an airport! Approximately 5–10 minutes before the scheduled start, someone will typically escort your group to the appropriate meeting room.

FDA attendees generally include subject matter experts from the disciplines relevant to the meeting agenda. However, those attending are not necessarily everyone who reviewed your submission. Many additional FDA experts may have contributed to the review but will not attend if their expertise is not directly relevant to the discussion or if there’s enough representative from their discipline. For meetings involving statistical issues, at least one clinician is almost always present. Depending on the topics, attendees may also include chemists, clinical pharmacologists, engineers, and other specialists.

Typically, the sponsor submits a meeting request and briefing materials well in advance. Before the scheduled meeting, the FDA generally provides preliminary written responses to the sponsor’s questions, often about two days beforehand, depending on the meeting type. After reviewing these responses, the sponsor may decide to cancel the meeting if all questions have been adequately addressed. If further discussion is needed, the meeting proceeds, and the sponsor can prioritize selected topics rather than attempting to cover every question in the original package.

How to approach an FDA meeting

First, consider the meeting format: in person or virtual? For in-person meetings, travel logistics require planning. Sponsors often arrive in the Washington, D.C., area the day before.

Next, determine who should attend. The team should include experts who can address the planned discussion topics, along with appropriate company leadership.

Perhaps the most important aspect of preparing for an FDA meeting, however, is mindset. Meeting with the FDA can feel intimidating, but it helps to remember that FDA reviewers are people too. They are dedicated, hardworking scientists who evaluate scientific evidence to inform regulatory decisions. Thinking of them as scientific colleagues responsible for ensuring quality and rigor within the medical product development ecosystem can make these interactions more constructive.

Ultimately, our goal is to provide compelling scientific evidence supporting our proposals, whether related to clinical trial design or regulatory approval. For statistical issues, this often means providing analytical justification or simulation-based evidence demonstrating that a proposed design adequately controls the Type I error rate while achieving reasonable and feasible operating characteristics. In approaching this, it is vital to keep the broader context in mind. Clinical relevance and operational considerations are integral to statistical decision-making and should be incorporated into the overall evaluation of a proposed design.

While these observations describe what FDA meetings typically look like, sponsors often develop additional insights after participating in multiple regulatory interactions.

Successful FDA meetings: Lessons for sponsors

One of the most important lessons sponsors learn is that a successful FDA meeting is largely determined before the meeting begins. The quality of the briefing package, the clarity of the questions posed to the Agency, and the alignment of the internal team typically have a greater impact on the outcome than anything said during the one-hour discussion itself.

Less experienced sponsors sometimes approach these meetings as opportunities to persuade the FDA through presentations. In practice, reviewers have already evaluated the submitted materials and often have preliminary positions on the key issues. As a result, the meeting is usually most valuable when focused on clarifying scientific questions, resolving areas of uncertainty, and obtaining feedback on specific development decisions rather than reiterating information already provided in the briefing package.

Ask focused, actionable questions

A related lesson is the importance of asking focused, actionable questions. Vague questions often yield general responses, whereas clearly defined proposals supported by data allow the FDA to provide more meaningful guidance. Sponsors should be explicit about the decisions they are trying to make and the feedback they need from the Agency.

FDA preliminary responses often reveal where discussion is most needed. Experienced teams use this feedback to refine their objectives and focus the meeting on unresolved issues. In many cases, some topics may already be sufficiently addressed, allowing the discussion to concentrate on the issues that remain unresolved. A prioritized agenda helps ensure that limited meeting time is spent where it can have the greatest impact.

Ensure the internal team is prepared and aligned

Preparation of the meeting team is equally important. Internal rehearsals can help align messaging, identify potential weaknesses in proposals, and ensure that subject matter experts are prepared to address likely questions. A coordinated team that provides clear, consistent responses inspires confidence and allows discussions to proceed efficiently.

From a statistical perspective, robust scientific evidence is essential. Whether proposing an adaptive design, a novel endpoint, an enrichment strategy, or an alternative analysis approach, sponsors should be prepared to support their recommendations with simulations, operating characteristics, sensitivity analyses, and a transparent discussion of assumptions. Strong quantitative justification often transforms potential points of contention into productive scientific discussions.

Don’t get discouraged by disagreement

Finally, sponsors should recognize that disagreement is not necessarily a negative outcome. FDA feedback that challenges assumptions or identifies potential risks can be invaluable, particularly when received early enough to influence development plans. The objective is not simply to obtain agreement, but to gain a deeper understanding of the scientific and regulatory considerations that will shape the path forward. Sponsors who approach these interactions with preparation, openness, and scientific rigor are often best positioned to strengthen both their development programs and their long-term relationship with the Agency.

Final takeaways

In summary, be prepared to answer the question, “Show me the scientific evidence.”

Strong scientific justification, supported by data, analytical reasoning, or simulation evidence, is essential for productive FDA interactions. Ask focused, actionable questions that encourage meaningful feedback and help address key scientific and regulatory uncertainties. Most importantly, view the FDA as a partner in the medical product development process, with a shared goal of bringing safe and effective treatments to patients. Disagreement is not necessarily a negative outcome. It can lead to valuable scientific discussions, a better understanding of the Agency’s concerns, and a clearer path forward. Ultimately, a successful FDA interaction is not simply about obtaining agreement, but about gaining clarity, strengthening the scientific approach, and advancing the development program.

Interested in learning more?

Join Xiting and Melissa for their upcoming webinar, “Across the Table from the FDA: Preparing for Successful Regulatory Interactions” on November 4:

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