FDA report demonstrates support for personalized medicine and more efficient regulatory pathways.

In a new report issued by the Food and Drug Administration (FDA) on October 28, 2013, Commissioner of Food and Drugs Margaret Hamburg declared her priority is “to continue to evolve FDA’s regulatory processes in response to – and in anticipation of – scientific developments that are critical for the development of personalized therapeutics and diagnostics.” The report, titled Paving the Way for Personalized Medicine: FDA’s Role in a New Era of Medical Product Development, describes “the unique and special role and responsibility that FDA has in helping to usher in the medical products that are central” to the practice of personalized medicine. Reinforcing the Agency’s commitment to support the development of personalized medicine and emphasizing the Agency’s intent to provide further “clarity and guidance to industry,” the report reviews the potential benefits and current challenges presented by the trend towards personalized medicine, and details steps the Agency has taken to both prepare for and facilitate this fundamental change in patient care.

The Goals of Personalized Medicine: FDA’s Perspective -

FDA’s report broadly defines “personalize medicine” 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.” FDA emphasizes that personalized medicine is not limited to pharmaceutical treatments, and describes wireless technologies, advances in computational power and medical imaging, stem cell research and the Internet as all playing a role in the development of personalized medicine.