Paving the Way for Personalized Medicine: FDA's Role in a New Era of Medical Product Development

The term "personalized medicine" is often described as providing "the right patient with the right drug at the right dose at the right time." More broadly, "personalized medicine" may be thought of as the tailoring of medical treatment to the individual characteristics, needs, and preferences of a patient during all stages of care, including prevention, diagnosis, treatment, and follow-up. Consistent with FDA's core mission, the agency is working in collaboration with researchers, manufacturers of drugs, medical devices and biologics, health care professionals and others to better understand and adapt to the promise of personalized medicine. FDA's ongoing efforts to make personalized medicine possible touch on various facets of product development and use including: Early Stage Development, Regulatory Pathways and Policies, Product Use.