ABSTRACT
Food and Drug Administration’s (FDA) mission is to protect and promote the health of all Americans through assuring the safety, efficacy, and security of drugs, biologics, and medical devices, and the safety and security of foods, cosmetics, and many other consumer goods. For well over a decade, personalized medicine has changed the FDA while the FDA, in turn, has changed personalized medicine. The term “personalized medicine” is often described as providing “the right patient with the right drug at the right dose at the right time”. Pharmacogenomics, the study of variations of Deoxyribonucleic acid and ribonucleic acid characteristics as related to drug response, is one of the most exciting areas of personalized medicine. The success of personalized medicine depends on the development of accurate and reliable diagnostics and, in some cases, on the identification of predictive biomarkers. The development and regulatory review of personalized medicine products raise a number of regulatory, policy, sponsor coordination, and review management challenges.
