Regulatory Science: The Maturation of an Evolving Scientific Discipline

Regulatory science encompasses the participation of a large array of scientific disciplines involved in the regulatory process. Although each discipline addresses different phenomenology and exploits different methodologies, the common scientific core is the same: objective pursuit of verifiable and useful knowledge. This paper updates the definition and scope of the practice of regulatory science, starting with a concise historical overview. It then examines the different phases of regulatory science applications: initial, exploratory, and standard operating. The paper also reviews the definitions of regulatory science used by various agencies and provides abbreviated scientific definitions. The paper summarizes Best Available Regulatory Science (BARS) and Metrics for Evaluation of Scientific Claims (MERSC), along with key elements and tools of regulatory science: peer review; regulatory science ethics, including the so-called Jeffersonian principle; mathematical models; cost benefit analysis; and stakeholder participation. The paper concludes with a brief description of these key tools and elements, highlighting their importance in the field of regulatory science.