title: Evaluating oversight of human drugs and medical devices: a case study of the FDA and implications for nanobiotechnology.
abstract: This article evaluates the oversight of drugs and medical devices by the U.S. Food and Drug Administration (FDA) using an integration of public policy, law, and bioethics approaches and employing multiple assessment criteria, including economic, social, safety, and technological. Criteria assessment and expert elicitation are combined with existing literature, case law, and regulations in an integrative historical case studies approach. We then use our findings as a tool to explore possibilities for effective oversight and regulatory mechanisms for nanobiotechnology. Section I describes oversight mechanisms for human drugs and medical devices and presents current nanotechnology products. Section II describes the results of expert elicitation research. Section III highlights key criteria and relates them to the literature and larger debate. We conclude with broad lessons for the oversight of nanobiotechnology informed by Sections I-III in order to provide useful analysis from multiple disciplines and perspectives to guide discussions regarding appropriate FDA oversight.
authors.affiliation: Seton Hall University School of Law, USA.
authors.forename: Jordan
authors.initials: J
authors.lastname: Paradise
authors.forename: Alison W
authors.initials: AW
authors.lastname: Tisdale
authors.forename: Ralph F
authors.initials: RF
authors.lastname: Hall
authors.forename: Efrosini
authors.initials: E
authors.lastname: Kokkoli
mesh_terms: D032921:Consensus; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence; D003661:Decision Support Techniques; D004335:Drug and Narcotic Control / Q000266:history / Q000331:legislation & jurisprudence; D049672:History, 19th Century; D049673:History, 20th Century; D006801:Humans; D033183:Interdisciplinary Communication; D050997:Nanomedicine / Q000331:legislation & jurisprudence*; D019982:Organizational Case Studies; D011050:Policy Making; D012196:Review Literature as Topic; D013673:Technology Assessment, Biomedical; D014481:United States; D014486:United States Food and Drug Administration / Q000266:history