Regulatory Science

Advancing regulatory science, advancing regulatory practice

In an Editorial of Science in 2011, Margaret A. Hamburg, the then Commissioner of the US Food and Drug Administration highlighted that a strong field of regulatory science is required to develop new tools, standards and approaches that efficiently and consistently assess the safety, efficacy and performance of products, and that this field has long been underappreciated and underfunded.1 During...

Boundaries of Regulatory Science

Hormesis in Regulatory risk assessment - Science and Science Policy.

This brief commentary will argue that whether hormesis is considered in regulatory risk assessment is a matter less of science than of science policy. I will first discuss the distinction between science and science policy and their roles in regulatory risk assessment. Then I will focus on factors that influence science policy, especially as it relates to the conduct of risk assessments to info...

From Science and Engineering to Regulatory Requirements

systems play an essential role in today’s biopharmaceutical processes. Recombinant E. coli and yeast systems are dominant tools in early discovery of effective medical targets. These systems are also routinely used to produce biological reagents for analytical methods in research and quality controls of products. In the biopharmaceutical industry, microbial systems have delivered major medicine...

Regulatory Science- towards a Sociological Framework-’

The close relationship between scientific expertise and regulatory policy in certain controversial and public areas has prompted commentators to suggest the concept of ‘regulatory science’. However, definition is generally constrained either to the concerns of regulatory science or to its context. This paper proposes an approach to regulatory science which is both empirically-based and allows a...