Regulatory bodies employing such principles in the United States include, for example, the FDA for food and medical products, the EPA for the environment, and the OSHA for work safety.
It was probably coined sometimes in the late 1970s in an undated memorandum prepared by A. Alan Moghissi, who was describing scientific issues that the newly formed US Environmental Protection Agency (EPA) was facing [citation needed].
These include human health and ecological risk assessment procedures and post marketing evaluation method d processes for drugs ad medical devices.
Regulatory science challenges current concepts of benefit/risk assessment, submission and approval strategies, patient’s involvement and ethical aspects.
It creates the platform for launching new ideas – not only by the pharmaceutical industry and regulatory authorities, but also by, for example, academia, who wants to contribute to better use of their research activities within medical aspects.
Regulatory science [7] has the potential as an enabler for directing companies towards more efficient global development of medical products as well as more robust quality decision-making processes.
This realm covers a broad range of scientific areas – including pollution and toxicology, work safety, food, drugs, and numerous others.
For example, the US Clean Water Act is based upon an interest in protecting water quality for its own sake, in contrast with the Clean Air Act which is premised upon protecting air quality only for the sake of human health; however, these are ideological policy premises rather than scientific matters themselves.
The US Department of Interior, Fish and Wildlife Service (USFWS), and National Oceanographic and Atmospheric Administration, National Marine Fisheries Service, implement the development and enforcement of policies required by the Federal Endangered Species Act (FESA), Migratory Bird Treaty Act, and other biological resources laws.
Regulatory scientists within the Services review, evaluate, and incorporate data from these studies of proposed species in their published regulations.