Regulatory Science: What It Is and Why We Need It

FitzGerald, G. A.
February 2011
Clinical Pharmacology & Therapeutics;Feb2011, Vol. 89 Issue 2, p291
Academic Journal
"Regulatory science" could be interpreted as the ''brand'' of science pursued by regulatory agencies such as the US Food and Drug Administration (FDA). The discipline enhances the science base of such agencies, and offers an incentive to sponsors to accelerate understanding of the spectrum of action of therapeutics in ways pertinent to the personalization of medicine. The development of expertise in translational medicine and therapeutics (TMAT) in academia and industry enhances the benefit for public health.


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