FDA Meeting Prep

Preparing for FDA Meetings

At Facet, we take a fresh approach to preparing for and participating in FDA meetings that has a proven track record of success.  We meet with FDA on average once every week.

We are experienced and our approaches work.

We have used each interaction to hone our strategies to help you meet or even exceed your goals for your FDA meeting.  We are well-versed in the formalities as well as the subtle nuances of FDA meetings and can help you navigate this territory, especially if you have never participated in an FDA meeting before.  Knowing what to expect and taking the uncertainty out of the situation enables optimal performance and improved outcomes.

Contrary to popular belief, FDA meetings are intended to help the Sponsor better understand FDA’s thinking on topics related to the Sponsor’s development program and product.  FDA meetings are not to help FDA better understand the Sponsor or their product, although this can and does happen in a good meeting!

We help Sponsors formulate the right questions to ask FDA and prepare robust yet succinct meeting requests and background packages to get clear and actionable guidance from the Agency.

Once FDA preliminary comments are received, Facet can help you organize your next steps using a success-proven method to ensure you have a dynamic, interactive discussion with the Agency during the meeting.

We help you to respectfully ask for what you want and support your position with sound science. We are always looking for ways to help FDA say “Yes”!

FDA has provided direct feedback to us and to our clients that our meeting preparation methods work! 

Even better, our clients resoundingly report that their meetings are successful from their point of view and that they could not have been more well-prepared.

Let Facet help guide you toward FDA meeting success! 

Contact us to learn more.

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