Some Definitions of Regulatory Science
While no official definition of regulatory science has been promulgated by any U.S. regulatory agency or standards-setting body, the following definitions highlight a common theme: drawing science and policy together for the benefit of public health and safety:
similar regulatory agencies world-wide) comprising public protection-oriented medical product regulations, policy and decisions using scientific methods employing empirical and causal evidence utilized in the evaluation and approval of all the products that FDA regulates.
Thus the role of regulatory science is inherent in FDA’s functioning as a scientific agency. It plays a critical role in all aspects of the agency’s mission, including:
review and assessment of laboratory data;
review and assessment of animal and human clinical data;
facilities inspection; and
development of technical and scientific standards for preclinical