Partnering with the FDA

The US Food and Drug Administration (FDA) has existed for more than 150 years, tracing back to the creation of the Agricultural Division in 1848. Although the mission and infrastructure of the FDA have evolved to a great extent, the basic principle has remained the same—to protect the health of the public. This chapter will walk through the structure and mission of the FDA and will examine best practices for sponsor companies who seek collaborative and successful relationships with the agency to support the efficient development of products to improve human health. This chapter will also walk through the different interactions with the FDA and explore strategies for ensuring optimal FDA engagement in your program(s). Furthermore, this chapter will highlight key opportunities for sponsors to successfully partner with the FDA to enable their programs to progress from the bench to the clinic to commercialization with ease. This chapter will also explain the role and benefits of Special Designations and Accelerated Approval Pathways, will highlight the FDA’s special initiatives and points of interest, and will help the reader understand how to keep up in this constantly evolving field.