FDA at BIO 2011 – Weighing a hefty mission: Where is the balance?

1969 ◽  
Vol 17 (4) ◽  
Author(s):  
Suzanne Levy

The mission of the Food and Drug Administration (FDA) is to promote public health by ensuring the safety and quality of food and medical products sold in the United States. At this year's annual Biotechnology Industry Organization (BIO) convention, significant discussion revolved around the appropriate interpretation and execution of that mission.The BIO meeting hosted 15 646 participants from across industry, government and the nonprofit sector, focusing on the current state of the biotechnology industry, as well as its challenges in seeking to further improve public welfare. Perhaps partly because this year's meeting was held in Washington, DC – the seat of the federal government and of BIO's headquarters – much attention was paid to the US regulatory environment. In particular, attendees debated the quandary faced every day by the FDA: how to enable access to novel therapies quickly, but only once their safety has been certified.

Author(s):  
Arne L. Kalleberg

This chapter discusses how the growth of precarious work and the polarization of the US labor market have produced major problems for the employment experiences of young workers. A prominent indicator of young workers’ difficulties in the labor market has been the sharp increase in their unemployment rates since the Great Recession. Another, equally if not more severe, problem faced by young workers today is the relatively low quality of the jobs that they were able to get. Other problems include the exclusion of young workers from the labor market and from education and training opportunities; the inability to find jobs that utilize their education, training, and skills; and the inability to obtain jobs that provide them with an opportunity to get a foothold in a career that would lead to progressively better jobs and thus be able to construct career narratives.


SAGE Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 215824402110361
Author(s):  
Gentian Qejvanaj

Roma segregation in Albania has been causing growing concern since the fall of the communist regime. In this study, we analyze the effectiveness of the Albanian national action plan for Roma inclusion 2016–2020, in 2018, halfway in its implementation period. We gathered data on education and employment from the pre-implementation period (2015) and compared it with the latest available data in 2018. Interviews with local experts and surveys by the Balkan Barometer will provide background information to assess the current state of Roma integration in Albania. Moreover, descriptive statistics from national and international institutions and structured interviews will draw an independent narrative of Roma affairs. In our conclusion, we suggest moving beyond the “us and them” approach with programs run on inertia; our findings highlight that although encouraging achievements have been reached under the 2016–2020 action plan, real inclusion is still far, as statistical achievements do not say much about the quality of the education or job training provided under the 2016–2020 action plan.


Author(s):  
Amanda Henton ◽  
Thanos Tzounopoulos

Tinnitus is a pervasive public health issue that affects approximately 15% of the United States population. Similar estimates have also been shown on a global scale, with similar prevalence found in Europe, Asia, and Africa. The severity of tinnitus is heterogeneous, ranging from mildly bothersome to extremely disruptive. In the United States, approximately 10-20% of individuals who experience tinnitus report symptoms that severely reduce their quality of life. Due to the huge personal and societal burden, in the last twenty years a concerted effort on basic and clinical research has significantly advanced our understanding and treatment of this disorder. Yet, neither full understanding, nor cure exists. We know that tinnitus is the persistent involuntary phantom percept of internally-generated non-verbal noises and tones, which in most cases is initiated, by acquired hearing loss and maintained only when this loss is coupled with distinct neuronal changes in auditory and extra-auditory brain networks. Yet, the exact mechanisms and patterns of neural activity that are necessary and sufficient for the perceptual generation and maintenance of tinnitus remain incompletely understood. Combinations of animal model and human research will be essential in filling these gaps. Nevertheless, the existing progress in investigating the neurophysiological mechanisms has improved current treatment and highlighted novel targets for drug development and clinical trials. The aim of this review is to thoroughly discuss the current state of human and animal tinnitus research, outline current challenges, and highlight new and exciting research opportunities.


Author(s):  
Viktoriya Sizova

The article is devoted to the study of the evolution, development and current state of the us criminal law system. The author considers the characteristic features inherent in modern American criminal law, its features, as well as the practical value and significance in relation to the continuity of positive experience.


Author(s):  
Patrick Cullen

The United States' diplomatic security apparatus that operates today from Washington DC to Iraq and Afghanistan is uniquely massive. It is incomparable in its size, budget, degree of institutionalization, and level of sophistication when set against both other nations as well as its own humble origins in WWI. To understand why this is so, the first half of this chapter historically maps and causally explains how, and why, US diplomatic security has been transformed over the course of its modern hundred-year history. The second half provides an empirically rich study of the various roles and functions of the State Department's Bureau of Diplomatic Security and the US military units that protect the US diplomatic mission.


Author(s):  
Christian Leuprecht

This chapter reviews the member organizations of the United States Intelligence Community, the strategic environment that has informed intelligence and accountability in the United States, including scandals as a key driver of innovation, and the current and future threat environment as seen by the United States. The chapter examines the US intelligence accountability architecture: the House of Representative Permanent Select Committee on Intelligence, the Senate Select Committee on Intelligence, the Foreign Intelligence Surveillance Court, the Inspectors General, the Government Accountability Office, the Privacy and Civil Liberties Oversight Office, and the President’s Intelligence Advisory Board. The sheer number and complexity of accountability bodies in the US gives rise to inefficiencies, ineffectiveness, and duplication. The accountability system is replete with gaps and vulnerabilities: partisanship, collective-action problems, resource allocation, and inconsistent quality of review in congressional accountability; GAO’s limited authority to review the USIC and sensitive operations; the adequacy of the FISA court in adequately protecting the rights of Americans; and Presidential discretion in appointing and removing IGs. These issues have implications not just for the United States, but for allies, partners as well as regional and global stability.


Author(s):  
Dafydd Townley

The Watergate affair has become synonymous with political corruption and conspiracy. The crisis has, through fact, fiction, and debate, become considerably more than the arrest of five men breaking into the Democratic Party’s national headquarters in the Watergate complex in Washington DC in the early hours of Saturday, June 17, 1972. Instead, the term “Watergate” has since come to represent the burglary, its failed cover-up, the press investigation, the Senate enquiry, and the eventual resignation of the thirty-seventh president of the United States, Richard Nixon. Arguably, Watergate has come to encompass all the illegalities of the Nixon administration. The crisis broke when the Vietnam War had already sunk public confidence in the executive to a low ebb, and in the context of a society already fractured by the turbulence of the 1960s. As such, Watergate is seen as the nadir of American democracy in the 20th century. Perversely, despite contemporaries’ genuine fears for the future of the US democratic system, the scandal highlighted the efficiency of the US governmental machine. The investigations that constituted the Watergate enquiry, which were conducted by the legislative and judicial branches and the fourth estate, exposed corruption in the executive of the United States that stretched to the holder of the highest office. The post-war decades had allowed an imperial presidency to develop, which had threatened the country’s political equilibrium. Watergate disclosed that the presidency had overreached its constitutional powers and responsibilities and had conspired to keep those moves hidden from the electorate. More significantly, however, the forced resignation of Richard Nixon revealed that the checks-and-balances system of government, which was conceived almost 200 years before the Watergate affair, worked as those who devised it had planned. Watergate should illustrate to Americans not just the dangers of consolidating great power in the office of the president, but also the means to counteract such growth.


Land ◽  
2020 ◽  
Vol 9 (3) ◽  
pp. 64
Author(s):  
Robert D. Brown ◽  
Tamanna Tasnum ◽  
YouJoung Kim

Landscape architecture programs in the United States are assessed based on the quality of the professional education received by their students. Research is becoming an increasingly important part of the profession as evidence-based landscape architecture grows, and it is critical that university faculty provide information that can be used in professional practice to resolve important environmental and social issues. In many universities, individual landscape architecture faculty are encouraged to conduct research and their performance is evaluated based largely on the quantity and quality of their scholarly output. This paper used publicly-available information to conduct a citation analysis for individual faculty and professionally accredited landscape architecture programs across the US. There was a wide range in the contribution level with some programs and some individuals who were very productive, while many others contributed very little. This might point to an attempt by programs to maintain a balance between scholarly contributions and the education of professional landscape architects. As research becomes an increasing important part of the profession, the productive programs and individuals identified in this study might provide models for others to emulate.


2020 ◽  
Vol 9 (9) ◽  
pp. 523
Author(s):  
Dapeng Li ◽  
Yingru Li ◽  
Quynh C. Nguyen ◽  
Laura K. Siebeneck

This study examines the characteristics of the members in the most popular Geographic Information Systems (GIS) Professional (GISP) certification program in the United States as well as the spatial patterns of the certified GISPs. The results show that the majority of GISPs (97.3%) are located in urban areas. About 75% of the GISPs are male. Among all the GISPs, 3971 GISPs (43.3%) play a managerial role, while 4983 individuals (54.5%) assume a non-administrative role. Among the GISPs with a non-administrative role, 348 GISPs (7%) fall within the GIS Developer group, 3392 GISPs (68%) belong to the GIS Analyst group, and 1243 GISPs (25%) play other roles. Additionally, in our analysis of spatial patterns, we identified two hotspots and two coldspots. The first hotspot is centered around Idaho and Wyoming, while the second hotspot includes Virginia, Washington DC, and Maryland. One coldspot is along Iowa, Missouri, Arkansas, and Louisiana in the central U.S., while the other coldspot includes states such as Connecticut, New Jersey, and New York on the east coast. The information presented in this study can help GIS educators and practitioners develop a better understanding of the current state of this certification program in the U.S and shed light on how to further improve the GISP certification program.


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