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.