FDA meetings play a critical role in any sponsor’s development strategy. They provide sponsors the opportunity to seek out critical agency feedback, identify gaps in required data, and come to agreement on whether the studies that have been conducted are sufficient for FDA review. These meetings also provide sponsors the opportunity to educate the FDA about their product – so reviewers have a basis of background and understanding once the NDA is submitted. This background is particularly helpful with new compounds that are being developed with cutting edge technology or innovative mechanisms of action, which may not be familiar to agency officials. That said, it takes experience, preparation and planning to ensure sponsors get the ultimate benefit from each FDA meeting. Here, I share some high-level suggestions.