ABSTRACT
Face-to-face meetings with the FDA are a critical component of the regulatory review and approval process for new prescription drugs, biologics, and medical devices. These direct exchanges between Agency personnel and company scientists provide a forum for the sharing of information that is essential to demonstrating the safety, efficacy, and quality of a product to the FDA’s satisfaction. The purpose of this chapter is to illustrate the types and objectives of various meetings with the FDA and to highlight some of the pitfalls and critical success factors associated with Agency interactions. While the main focus of the chapter is on drugs, the principles apply broadly to all meetings with the FDA.
