October 02, 2018 Feature

Regulatory Frameworks for Precision Medicine at the Food & Drug Administration

By Jordan Paradise

The concept of precision medicine is not new; its promise and allure have a rich history in genetics and genomics, building squarely on international research efforts begun decades ago and culminating in the publication of the complete human genome sequence in 2004.1 Now, nearly 15 years following the conclusion of the Human Genome Project (HGP), the terminology describing the idea of channeling genomic information into more targeted medical products has evolved, to include pharmacogenomics, personalized medicine, targeted medicine, and, most recently, precision medicine. All envisage the ability to make medical care and medical products “precise” for the patient; that is, tailored to an individual’s genetic makeup in order to maximize safety, efficacy, mortality, and quality of life. In his unveiling of the Precision Medicine Initiative in 2015, President Obama noted this program is about “delivering the right treatments, at the right time, every time to the right person.”2

Premium Content For:
  • Science and Technology Law Section
Join - Now