This guide was created to support the Regulatory Science Consultative Service (RSCS) at the Rogers College of Law and to serve as a resource for Arizona Law students exploring regulatory science and related fields. Primary focus is on the U.S. Food and Drug Administration and its functions.
Food and Drug Administration (FDA) - The primary agency involved in advancing the field of regulatory science is the Food and Drug Administration which sets policy and formulates rules and regulations governing how new drugs and medical devices are developed, approved, and brought to market. The FDA web site has information on the approval processes for drugs, medical devices including IND and IDE activity and reports, and more. The Advancing Regulatory Science portion of the site includes descriptions of and links to their various initiatives (eg.Critical Path Initiative and the more recent Advancing Regulatory Science Initiative) as well as status reports and strategic plans.
In addition to the FDA's role in the field of regulatory science, another HHS entity, the National Institutes of Health (NIH), has information for members of the public and clinicians about participation in clinical trials including lists of registries, and also provides policy information and information about funding for grant seekers. NIH also has a database of clinical studies taking place world-wide and at their Bethesda location.
Other NIH/FDA units involved in aspects of regulatory science include:
For information on the regulatory process of HHS agencies, the Laws and Regulations portion of the HHS.gov page the offers links to a "semi-annual regulatory agenda" which "lists all HHS regulations under development or review," in addition to proposed rules and rulemaking priorities for the current year.
The FDAs Regulatory Information page includes not only the current rules and regulations but also legislation including the text of the Food, Drug, And Cosmetic Act (FDCA-the FDAs authorizing legislation from ) and the Food and Drug Administration Safety and Innovation Act (FDASIA). as well as a history of amendments.
To search for notices of proposed rulemaking or to read or add comments during an open comment period of the process, check Regulations.gov , the official portal for all federal agency rulemaking activity. The site uses the Federal Dockets Management System (FDMS), a document management sytem for storing and accessing all administrative activity by federal agencies, including the FDA.
Sources for existing laws and rules for all federal agencies include the Cornell Legal Information Institute (LII) which maintains current online versions of the US Code and the Code of Federal Regulations (CFR); the Office of the Federal Register. Historical issues of the FR (from 1994) through the current issue are also available on FDSys, the GPO's Federal Digital Sysem.
The NIH funds several initiatives to advance the field of regulatory science including: the National Center for Advancing Translational Sciences (NCATS) to facilitate the development of new technologies and the Clinical & Translationsl Science Awards (CTSA) Program, a consortium of more than sixty academic medical research institutions set up to '"... transform the local, regional, and national environment to increase the efficiency and speed of clinical and translational research across the country."
The FDA has also established partnerships with a handful of universities and non-academic research entities called Centers for Excellence in Research and Scientific Innovation (CERSI).The goal is to further their own efforts to fast-track the entry to market of new drugs and devices and reduce the hurdles of the current process.
Non-governmental partnerships include the Center for Responsible Science (CRS), a collaboration among "...scientific, medical, regulatory, business, and legal professionals who promote advances in regulatory science."
The NIH National Library of Medicine's MEDLINE database contains citations to journals in the fields of biomedicine, biotechnology, and life sciences. Access to content is through UA Main Libraries subscriptons to various providors including PubMed, OVID, and Ebscohost. Various publications are also available on the FDA web site such as Advancing Regulatory Science at the FDA, the agency's strategic plan from August 2011. For specific journal content, try entering the journal title into the library search box on the UA online catalog, eg. Food and Drug Law Journal. (This link is to Hein Online's copy.)