ABSTRACT
This chapter describes the unique and special role and responsibility that Food and Drug Administration (FDA) has in helping to usher in the medical products that are central to this larger effort. The report describes the ways in which FDA has evolved its regulatory processes in response to—and in anticipation of—scientific developments that are critical for the development of personalized therapeutics and diagnostics. “Personalized medicine” may be thought of as tailoring medical treatment to the individual characteristics, needs and preferences of each patient. Personalized medicine generally involves the use of two medical products—typically, a diagnostic device and a therapeutic product—to improve patient outcomes. The success of personalized medicine depends on the development of accurate and reliable diagnostics and, in some cases, on the identification of predictive biomarkers. In the long run, personalized medicine seeks to reduce the burden of disease by targeting prevention and treatment more effectively.
