Evaluating Oversight of Human Drugs and Medical Devices: A Case Study of the FDA and Implications for Nanobiotechnology

2009 ◽  
Vol 37 (4) ◽  
pp. 598-624 ◽  
Author(s):  
Jordan Paradise ◽  
Alison W. Tisdale ◽  
Ralph F. Hall ◽  
Efrosini Kokkoli

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. Throughout, assessments employing both the multiple criteria and a method of expert elicitation are combined with the existing literature, case law, and regulations providing an integrative historical case study approach. The goal is to provide useful information from multiple disciplines and perspectives to guide discussions regarding appropriate oversight frameworks for nanobiotechnology applications under the FDA’s purview.

2021 ◽  
Author(s):  
◽  
Victoria Catherine Passau

<p>The Elam School of Fine Arts amalgamated with Auckland University College in 1950, bringing with it a small collection of art books. From these beginnings the Fine Arts Library has developed into the well-funded and reputable arts library that exists today. Throughout its history the Library has supported the Elam School of Fine Arts and later the Department of Art History and has in turn been integrated into and supported by The University of Auckland Library system. This research utilised an historical case study approach to identify and analyse how this web of interconnected relationships has influenced the development, maintenance, and future of a specialised art library. The findings illustrate that, while the Elam School of Fine Arts and the Department of Art History have experienced considerable curricular and administrative changes, these have not had a significant impact on the efficiency and value of the Library. The Fine Arts Library’s collection and services have consistently supported and enhanced the teaching and research needs of these two entities. Despite accommodation, staffing and funding challenges, the Fine Arts Librarians and Library staff, succeeded in establishing a comprehensive and nationally recognised art library with a strong, vibrant and unique culture.</p>


2021 ◽  
Author(s):  
◽  
Victoria Catherine Passau

<p>The Elam School of Fine Arts amalgamated with Auckland University College in 1950, bringing with it a small collection of art books. From these beginnings the Fine Arts Library has developed into the well-funded and reputable arts library that exists today. Throughout its history the Library has supported the Elam School of Fine Arts and later the Department of Art History and has in turn been integrated into and supported by The University of Auckland Library system. This research utilised an historical case study approach to identify and analyse how this web of interconnected relationships has influenced the development, maintenance, and future of a specialised art library. The findings illustrate that, while the Elam School of Fine Arts and the Department of Art History have experienced considerable curricular and administrative changes, these have not had a significant impact on the efficiency and value of the Library. The Fine Arts Library’s collection and services have consistently supported and enhanced the teaching and research needs of these two entities. Despite accommodation, staffing and funding challenges, the Fine Arts Librarians and Library staff, succeeded in establishing a comprehensive and nationally recognised art library with a strong, vibrant and unique culture.</p>


1983 ◽  
Vol 43 (1) ◽  
pp. 251-259 ◽  
Author(s):  
Nola Reinhardt

The effect of the commercialization of traditional agriculture on the levels of living of peasant households is examined through a case study of El Palmar, Colombia. While there appear to have been widespread, positive, short-mn effects, the long-run consequences appear to be more problematic. It is suggested that commercialization and its consequences are more complex than can be grasped from available aggregate data, and a historical, case-study approach to this topic is recommended to complement macroeconomic studies.


2013 ◽  
Vol 38 (4) ◽  
pp. 58-69
Author(s):  
Yasser Elsheshtawy

This paper in its first part aims at contextualizing Abu Dhabi's urban development and understanding the factors that have governed its urban growth through a historical case study approach. Relying on archival records and primary sources five stages of urban growth are identified. Data mining of media archives allows for a first hand account of developments taking place thus grounding the depictions. The second part contextualizes this review through a case study of the Central Market project — also known as Abu Dhabi's World Trade Center. The paper concludes by elaborating on the significance of such a historical analysis as it shifts the discourse away from a focus on the ‘artificiality’ of cities in the Gulf to one that is based on a recognition about the historicity of its urban centers, however recent it may be. Additionally the pertinence of such an analysis for cities worldwide is discussed as well.


2021 ◽  
Author(s):  
◽  
Paula Jane Whitelock

<p>The Printer in Residence (PiR) Programme at the University of Otago has been running since 2003, and in that time, nine private press publications have been produced. Each year the programme commissions a skilled handcraft printer to produce a specific work (usually related to the University of Otago's art and literary history) in collaboration with local artists and print makers. Although there is valuable research being conducted in regards to New Zealand's print culture, this was aspect of New Zealand's private press history yet to be investigated. This study utilised an historical case study approach with an objective to document the recent history and development of the Printer in Residence(PiR) Programme through an investigation of its archives; interviews with eight of the programme's participants, and written accounts by two others. The study aimed to gain a holistic perspective of the PiR Programme by interviewing those involved in its administration and general operations, past Printers in Residence, and artists and print makers. Case studies of the 2005, 2006 and 2007 PiR Programmes highlight the collaborative process of producing a limited edition hand printed book, and unique characteristics of each PiR programme. The major themes identified from the data gathered were: the strong collaborative aspect of the PiR Programme; the importance placed on promoting the programme as a teaching opportunity to the English, Art History and Design departments; the hand crafted qualities of the books produced in comparison to commercial publishing, and the perceived value of the PiR programme for those involved in this study. This study identifies the PiR Programme as a small but important aspect of New Zealand's book history which is worthy of further research.</p>


1995 ◽  
Vol 17 (4) ◽  
pp. 438-461 ◽  
Author(s):  
Lauren B. Resnick ◽  
Katherine J. Nolan ◽  
Daniel P. Resnick

Recently, standards have become the currency of education reform efforts in the U.S. However, there is no international consensus on what constitutes “world-class” education. The New Standards Project has designed research to describe standards in other countries by using the case-study approach of ethnography to collect data (e.g., curricula, texts, exams, student work, and professional views). The review/analysis of the data is organized by a set of fundamental questions, the answers to which constitute a contextualized account of what students are expected to know and be able to do.


2015 ◽  
Vol 33 (1) ◽  
pp. 15-19
Author(s):  
Peter S. Defoe

Purpose – The purpose of this paper is to demonstrate the application of the ratio in Ankerson v Connelly 1906 2Ch 544(Ch) and 1907 1Ch 678(CA) to a modern domestic right to light situation and the need for rights of light surveyors to be aware of relevant case law when advising their client. Design/methodology/approach – This paper adopts a case study approach describing the circumstances of the case, the approach of the appointed experts and the decision of the court. Findings – The court found for the Respondent in that the Dominant Owner’s property had been altered to create an additional burden upon the Servient Owner and the altered part of the Dominant Owner’s property had not yet acquired an independent right to light through prescription. Originality/value – This is an unreported case that illustrates the application of a case decided over 100 years ago.


2021 ◽  
Author(s):  
◽  
Paula Jane Whitelock

<p>The Printer in Residence (PiR) Programme at the University of Otago has been running since 2003, and in that time, nine private press publications have been produced. Each year the programme commissions a skilled handcraft printer to produce a specific work (usually related to the University of Otago's art and literary history) in collaboration with local artists and print makers. Although there is valuable research being conducted in regards to New Zealand's print culture, this was aspect of New Zealand's private press history yet to be investigated. This study utilised an historical case study approach with an objective to document the recent history and development of the Printer in Residence(PiR) Programme through an investigation of its archives; interviews with eight of the programme's participants, and written accounts by two others. The study aimed to gain a holistic perspective of the PiR Programme by interviewing those involved in its administration and general operations, past Printers in Residence, and artists and print makers. Case studies of the 2005, 2006 and 2007 PiR Programmes highlight the collaborative process of producing a limited edition hand printed book, and unique characteristics of each PiR programme. The major themes identified from the data gathered were: the strong collaborative aspect of the PiR Programme; the importance placed on promoting the programme as a teaching opportunity to the English, Art History and Design departments; the hand crafted qualities of the books produced in comparison to commercial publishing, and the perceived value of the PiR programme for those involved in this study. This study identifies the PiR Programme as a small but important aspect of New Zealand's book history which is worthy of further research.</p>


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