The Art of Regulatory: Why FDA Is More Like a Dance Partner Than a Judge

When I first talk to startup founders about the FDA, I often see the same look. It is a mix of worry and uncertainty. Some are new to the process, and some have already been in the regulatory journey for years. They carry the weight of long timelines, repeated questions, and sometimes disappointing news. Many picture the FDA as a strict judge waiting to hand down a verdict.

That image is understandable. There are rules to follow, data to generate, and deadlines to meet. But if you only see the FDA as a judge, it can feel like a fight you can never win.

Working with the FDA is more like learning to dance. Both sides want to get to the same place: a safe and effective product in the hands of patients. How you move together matters as much as the outcome.

Listening and Timing

In dance, you have to pay attention to your partner’s signals. In regulatory, that means listening closely to the feedback you get. I have seen companies go into meetings ready to argue their case without hearing what the FDA is saying. The result is often more confusion and frustration.

Sometimes the FDA will tell you exactly what they want to see. Other times, you need to read between the lines and adjust your approach. 

It is not always about pushing your own plan forward. Sometimes you have to put your own interests aside and focus on understanding their concerns first.

Timing is important too. If you move too fast, you might step on toes. If you move too slow, you lose momentum. Knowing when to ask questions, when to present data, and when to pause can keep the process smooth.

Building Trust

Good dance partners trust each other. The same is true here. The FDA needs to trust that you understand your product and its risks. They need to trust that you will be open about problems and committed to solving them.

You can build that trust by being clear, consistent, and responsive. If you say you will send follow-up data by a certain date, do it. If there is an issue with a study, explain it and share how you will fix it.

Asking for Clarity

The FDA is made up of people. They have their own ways of communicating, and sometimes their feedback is not perfectly clear. That is normal.

I have had situations where a comment from the FDA could have been interpreted in several ways. Instead of guessing, we went back to them with a respectful request for clarification interactively. 

When you ask for clarification, be respectful of their workload. Be specific about what you need to understand. Use common sense and focus on solving the problem together. Show them that the conversation benefits both sides. If the discussion helps you address their concerns more clearly, it also makes their review easier and more efficient.

Here is an example of how you might write that into an email.

We want to ensure we fully understand your comments regarding [specific point or section] so that we can respond appropriately and align our next steps with FDA expectations. We believe that a short interactive discussion could help confirm our understanding and allow us to explore potential solutions together.

We believe this discussion will help ensure that our submission fully addresses your questions in a clear and organized way, which we hope will make your review process more straightforward and efficient.

Preparation

No one learns a dance by walking into a performance without practice. The same goes for regulatory submissions. You need to prepare your documents, practice your explanations, and anticipate the questions you might get.

Rehearsing your meetings, reviewing your data, and making sure your team is aligned will make the real thing much easier.

The Goal

When the FDA is seen only as a judge, the process feels like a trial. When you treat them as a partner, the process becomes a collaboration. You still need to meet high standards, but you do it with a shared sense of purpose.

The goal is not just to get clearance. The goal is to build a relationship where the FDA trusts you and your data, and you trust them to give you the feedback you need. That is how you bring a product to market in a way that serves both patients and your company.

And like any good dance, when it works, both partners walk away knowing they created something worth sharing.