FDA Meetings

Formal meetings with the leadership and reviewers of the US Food and Drug Administration (FDA) are one of the most important resources available to sponsors of medicinal products seeking marketing approval in the US. Since the FDA makes the final decision to approve or reject your product, it is highly recommended to hold face to face and teleconference meetings with FDA all along the development timeline. The FDA encourages these discussions starting as early in the development process as possible so that sponsors can become aware of concerns and be able to address issues before formal submission of a marketing application. Periodic and timely meetings with the FDA have been shown to dramatically increase the probability of timely FDA approval.

PharmaLex can help you every step of the way, ensuring a highly professional interaction with the FDA. We assist with the preparation of meeting requests and background documents, conduct rehearsals and facilitate on site at the FDA meetings, and prepare meeting minutes. Our staff has led hundreds of successful meetings with FDA, and we are ready to help you achieve your meeting goals with the FDA.


FDA Meetings – How to get the best advice

Periodic and timely meetings with the FDA have shown to increase the probability of a rapid market approval and can have a direct impact on development costs. But how do you get the best advice?

We have prepared a quick guide for you, which is now available for download. This document is designed to serve you as guidance and as a useful tool for your next FDA meeting.

FDA Meeting Thumb