BOX 2-1

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:

  • “…the science and tools we use to assess and evaluate a product’s safety.” Margaret Hamburg, FDA Commissioner (FDA, 2009)

  • “The development and use of new tools, standards and approaches to more efficiently develop products and to more effectively evaluate product safety, efficacy and quality.” Announcement of NIH–FDA Collaboration to Fast-Track Innovations to the Public (FDA, 2010c)

  • “The acquisition and analysis of data sufficient to inform decision making pertinent to the approval of safe and effective therapeutics, devices and cosmetics and ensuring the safety and nutritional value of the food supply.” Garret FitzGerald, University of Pennsylvania School of Medicine (FitzGerald, 2010)

  • “Regulatory science is a unique application of science, at all levels, to the societal decision process.” Alan Moghissi, President, Institute for Regulatory Science (The Scientist, 2009)

  • “Regulatory Science relates the regulatory and legal requirements of biomedical product development to the scientific research needed to ensure the safety and efficacy of those products.” Academic website for the University of Southern California School of Pharmacy (USC, 2010)

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;

  • methods development;

  • facilities inspection; and

  • development of technical and scientific standards for preclinical

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