Nothing can impact the progress of your development efforts, both positively and negatively, than meeting with FDA regulators. A successful meeting gives you a clear path forward. A meeting that goes wrong leaves you without that path forward and, possibly, broken relationships with FDA reviewers. The key here knowing how to ask questions in a way that will ensure that the FDA scientist will provide a useful answer.
You may be tempted to pose one of the following questions: “If we commit to run the clinical trial in this way, will you give us the go-ahead to start it?” “If we have 12 months of stability data, will you grant a 24-month shelf life?” “If we submit the result of two clinical trials, with a total of this number of patients, will you approve the drug?”
The likely FDA answer to each of the above questions and, indeed, to any questions that are framed like them, is going to be, “That is a review issue. Next question.” This is the worst thing that can happen. FDA reviewers do not want to review large data sets twice: once to answer your question in the meeting, and then a second time when the actual submission comes in. There is a better way; a lesson I learned during a very awkward meeting with regulators from a Latin American nation.
I was asked to meet with regulators in this country by a previous employer to address some issues. What I did not realize is that the person in the regulatory agency who agreed to the meeting was out sick, nor was I aware that the dozen or so regulators were notified that my firm was bringing this ex-FDA guy (me) to tell them how things should be done. Yikes!

So, there I sat, with stony faces glaring at me. I swallowed hard and asked my colleague who was serving as my translator to tell the assembled regulators that I was there to learn what they needed to make a good public health decision for the citizens of their country. Upon hearing my question, I noticed relaxed expressions and smiles as I looked around the table. By posing that question first, I was able to enter a productive discussion about the kind of data that they were looking for in order to decide on the shelf life of my company’s product (the issue that I had
been brought in to support). Once we agreed on the necessary data, I was able to show them that our submission included that specific information, and the problem was resolved.

The simple lesson learned was this: if you frame a question to regulators in terms of “Will you approve this?” you are likely to receive a non-answer (i.e. “That’s a review issue”). If instead you frame the question differently, (i.e., “Here is the protocol we will use to get the data, will that give you the information that you need to make a good decision?”), you set the table for an effective back and forth about your research plans. You cannot get regulators to review and
approve a data set in a meeting, but you can get them to agree that your plans to generate data are good. And this is exactly what you need as you develop your product.

Need help talking to FDA? Let me help ask the right questions the right way to get answers to
help speed your drug to patients. Let’s talk about it.