Regulatory Science at the Rogers College of Law

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Maureen Garmon
Faculty Services Librarian

 Federal Agencies | Legislation & Regs | Compliance | Bioethics |
  Research Collaborations | Datasets & Statistics |
Tracking Developments | Funding Sources for Grant Seekers | Searching the Literature | Reference

       

 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.

Federal Agencies

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:

Office for Human Research Protections (OHRP) -  Provides guidance, policy documents and regulatory oversight for biomedical research using human subjects..

 Office of Clinical Research and Bioethics Policy (OCRBP) - at the NIH's Office of Science Policy is responsible for "...for planning, developing, and coordinating NIH-wide policy activities for clinical and health care research, as well as promoting full integration of bioethical considerations as foundational to NIH-supported research."  

Center for Biologics Evaluation and Research (CBER) - a unit within the FDA's Office of Medical Products and Tobacco whose mission is "...to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies."

The US Department of Health and Human Services website provides an overview of programs and services and includes an organizational chart of the various agencies under its umbrella along with their functions and interactive roles.

Legislation & Regs

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.


Compliance

Office of Inspector General (HHS) -  oversees  accountability and compliance for all HHS departments and offices, including fraud and whistle-blower investigations.


Bioethics

Hastings Center - Non-partisan research center offering reports and discussion forums as well as publications such as The Hastings Center Report and the Bioethics Forum,

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School - research and policy centered on bioethics and related issues. The Bill of Health blog features links to weekly podcasts on biotech and policy issues.


Research Collaborations

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."


Datasets & Statistics

openFDA - as of September 2015, this was still a beta site, including databases and datasets on FDA approvals for foods, drugs, and devices. According to their page: " The goal of the project is to create easy access to public data, to create a new level of openness and accountability, to ensure the privacy and security of public FDA data, and ultimately to educate the public and save lives. The concept was to index high-value public-access data, format and document that data in developer and consumer-friendly standards, and make that data available via a public-access portal that enables developers to quickly and easily use it in applications."

The FDA Project ( The Harvard Project on U.S. Pharmaceutical Regulation) - includes technical papers, empirical studies, historical information and more. According to the page's summary, the FDA Project is "a large-scale theoretical, historical and statistical analysis of pharmaceutical regulation in the United States as it is carried out by the U.S. Food and Drug Administration (FDA)."

HealthData.gov - has a database of nearly every drug approved by the FDA since 1939 including brand name and generic, OTC and biologics in their Drugs@FDA collection. They also have a page of FDA datasets which includes all products that must meet FDA approval.

Centerwatch - This industry-sponsored group tries to provide volunteers with company clinical trials and claims it has the "...largest online database of industry-sponsored global clinical trials actively seeking volunteers."  Also maintains a database of FDA-approved drugs for sale in the US along with clinical trial results  and indications for use.

REDCap  (Research Electronic Data Capture) - software tool available to REDCap consortium members to assist in organizing their survey data and databases.Several UA entities are REDCap members, including AZiCATS as a CTSA regional hub.

News / Tracking Developments

The FDA web site offers RSS feeds for tracking of latest developments via press releases. See the FDAs Office of Regulatory Affairs (the "...the lead office for all agency field activities" ) for FDA-related activity in the courts.

Law 360 - this subscription service  tracks news, regs, and litigation developments in the federal appellate courts. Arizona Law faculty should contact the library for individual usernames and passwords. Law students must access through their Lexis Advance login credentials. 

Funding Sources for Grant Seekers

 While the NIH is the more obvious source for funding for FDA and public health-related projects, the University of Arizona provides access to a couple of subscription-related sources such as PIVOT and GrantForward.      .

Searching the Literature

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 search box on the UA online catalog (eg. Food and Drug Law Journal).There are a handful of journals and blogs on the Office of the Federal Register web site. 


Reference

FDA Acronmys and Abbreviations -- good place to look for the meaning of the many abbreviations applied to various agency terms.

 

 

Research Category