Regulatory science is defined as science and research intended to inform decision making
in a regulatory framework. This issue of Clinical Pharmacology & Therapeutics and the …

Translational science refers to translating basic scientific findings to practical application
(ie,'bench-to-bedside'). An underappreciated aspect of translational science is regulatory …

This article analyzes the role of regulatory authorities in facilitating innovation in the
pharmaceutical sector. We describe how regulators are expanding their role to be not only …

“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 …

Against a backdrop of increasing costs and poor productivity, the concept of 'regulatory
science'has sometimes been invoked in recent years in discussions regarding regulation of …

The history of medicines regulation is punctuated with sudden swings in focus mandated by
a public injured by medicines and skeptical of regulators' abilities to protect them. As …

The “regulatory paradox” is a tension between aversion to uncertainty and willingness to
accept unknowns about a drug before its approval. Finding the right balance may mean the …

“What does not change is the will to change.”—Charles Olson,“The Kingfishers” The world is
in the midst of scientific revolutions that can transform medicine and public health. Yet …

We present a commentary on the international aspects of the evolution of regulatory science
as a multidisciplinary, multistakeholder academic discipline of education and applied …

At the turn of the century, the pharmaceutical industry began a transition toward a focus on
oncology, rare diseases, and other areas of high unmet need that required a new, more …