Meeting with the FDA
At Facet, we believe in the importance of working collaboratively with FDA at all stages of the drug development process. It is a two-way collaboration that requires appropriate, timely, and effective communication by both parties.
From the Sponsor side, both FDA and Facet’s motto for FDA interaction is to engage “early and often” with the Agency to discuss important aspects of development. Interaction is especially important for innovative, first-in-class products and products being developed for orphan and/or pediatric indications. We firmly believe that Sponsors who work with FDA in this manner receive higher quality and more timely feedback from regulators. In essence, we are helping the Agency help us bring valuable products to patients.
We also understand that meeting with FDA is a critical business activity as well as a regulatory one. Obtaining clear guidance and achieving agreement on regulated product development reduces business risk and increases the probability of success in achieving future regulatory milestones. In fact, timely feedback can result in more efficient development programs and significant cost savings.
FDA meetings are a routine part of Facet’s daily business.
- We average a minimum 25 FDA formal meetings per year plus countless informal interactions
- We support formal and informal meetings with all FDA centers: CDER, CBER, CDRH, and OGD
- We provide regulatory strategy around whether a meeting is necessary (it isn’t always!), and if so, what type of meeting or interaction should be requested
- We help to formulate precise questions, appropriate messaging in the background package, and discuss the strategy underlying who should attend the meeting
- We author meeting requests, background packages, and prepare and submit Sponsor meeting minutes
- Our rigorous preparation process ensures that meeting attendees are well prepared and nothing is left to chance
- We serve in several roles for meetings with FDA, based on customer need: emcee, scientific experts, and/or trainers who can teach your team how to hold a successful meeting with FDA (with backup to ensure that things don’t inadvertently run off the rails!)
Talk to us about helping you with your next FDA meeting!
Facet was incredibly thorough and efficient in helping us to prepare for our FDA meeting. We had the right people in the room and our rehearsals made the FDA meeting seem easy. We got clear direction and are now confident about our path forward.
Our methods for preparing and implementing strategies for FDA meetings has been honed from hundreds of combined years of experience working with FDA. We iteratively seek FDA feedback on how we champion meetings which is directly incorporated into our meeting activities with our clients.
Our goal is always to achieve a clear path forward and continue to foster a good working relationship with FDA reviewers and Agency senior management.
Our success is due to our rigorous preparation methods as well as our longstanding, exceptional reputation with FDA in providing the highest quality in everything we do.
gET sOCIAL