scholarly journals Comparison of supportive regulatory measures for pediatric medical device development in Japan and the United States

2020 ◽  
Author(s):  
Sara Takahashi ◽  
Kiyotaka Iwasaki ◽  
Haruki Shirato ◽  
Mami Ho ◽  
Mitsuo Umezu
Keyword(s):  
United States ◽  
Medical Devices ◽  
Large Scale ◽  
The United States ◽  
Priority Review ◽  
Regulatory Body ◽  
Scientific Papers ◽  
Alternative Measures ◽  
Regulatory Bodies ◽  
Further Development

Abstract Further development of medical devices for children is required in Japan, but the development of such devices is delayed compared to that of medical devices for adults. Herein, we investigated policies for advancing the development of pediatric medical devices in Japan and the United States. Considering the achievements of each policy, we proposed a strategy to promote further development of pediatric medical devices in Japan. We investigated policies for supporting the development of pediatric medical devices and approved cases in Japan and the United States by searching contents of websites of regulatory bodies and other related administrations, and scientific papers. We found the main six policies in Japan and nine main policies in the United States for the development of pediatric medical devices. In the United States, various measures have initiated mainly in the 2000s, while in Japan, the main measures have been in place since 2013. Similarities were found in both countries, such as subsidies for application fees and research and development expenses, exemption of requirements for regulatory approval, and priority review and consultation by the regulatory body. Our study revealed that there are similarities in initiatives by both countries. To promote further development of pediatric medical devices in the future, improvements to expediting the review process to approval by the regulatory body, global development, and implementation of alternative measures to ensure the efficacy and safety of the device instead of large-scale clinical trials should be anticipated through cooperation among industry, government, and academia.

scholarly journals Regulation of nursing practice in the Region of the Americas

2020 ◽  
Vol 44 ◽  
pp. 1
Author(s):  
Silvia Helena De Bortoli Cassiani ◽  
Kimberly Lecorps ◽  
Luz Karina Rojas Cañaveral ◽  
Fernando A Menezes da Silva ◽  
James Fitzgerald
Keyword(s):  
United States ◽  
Continuing Education ◽  
The United States ◽  
Nursing Schools ◽  
World Health ◽  
Regulatory Body ◽  
Regulatory Bodies ◽  
Health Nursing ◽  
Professional Registration ◽  
Health Organization

Objective. To describe and analyze the current nursing regulations across countries in the Region of the Americas. Methods. A country comparative analysis was carried out by gathering information from the ministries of health, nursing schools, councils, associations, and boards in 2018. The main categories evaluated were type of regulatory bodies, requirements for initial professional registration, and registration renewal. Results. All countries regulate the nursing profession through a regulatory body. Competency exams for initial registration are required in the United States, Canada, and most Caribbean countries. Registration renewal is required in 54.3% of the countries. Continuing education is required for professional registration renewal in the United States, Canada, and 53% of Caribbean countries. Labor hours are required in the United States and Canada. Conclusion. Regulations promote and protect professional integrity. The Pan American Health Organization/World Health Organization recommends that countries make efforts to evaluate competency and training, consider the use of competency exams for initial registration, and add continuing education as requirements for registration renewal.

Quality Control of Data in a Large-Scale Cancer Register Program

1966 ◽  
Vol 05 (02) ◽  
pp. 67-74 ◽  
Author(s):  
W. I. Lourie ◽  
W. Haenszeland
Keyword(s):  
United States ◽  
Quality Control ◽  
Cancer Patients ◽  
Large Scale ◽  
The United States ◽  
Newly Diagnosed ◽  
Related Data ◽  
Cancer Register ◽  
Independent Review ◽  
End Results

Quality control of data collected in the United States by the Cancer End Results Program utilizing punchcards prepared by participating registries in accordance with a Uniform Punchcard Code is discussed. Existing arrangements decentralize responsibility for editing and related data processing to the local registries with centralization of tabulating and statistical services in the End Results Section, National Cancer Institute. The most recent deck of punchcards represented over 600,000 cancer patients; approximately 50,000 newly diagnosed cases are added annually.Mechanical editing and inspection of punchcards and field audits are the principal tools for quality control. Mechanical editing of the punchcards includes testing for blank entries and detection of in-admissable or inconsistent codes. Highly improbable codes are subjected to special scrutiny. Field audits include the drawing of a 1-10 percent random sample of punchcards submitted by a registry; the charts are .then reabstracted and recoded by a NCI staff member and differences between the punchcard and the results of independent review are noted.

Utopias of One

2019 ◽  
Author(s):  
Joshua Kotin
Keyword(s):  
United States ◽  
Soviet Union ◽  
World War I ◽  
Large Scale ◽  
Jim Crow ◽  
Personal Autonomy ◽  
The United States ◽  
Soviet Period ◽  
Original Research ◽  
The Soviet Union

This book is a new account of utopian writing. It examines how eight writers—Henry David Thoreau, W. E. B. Du Bois, Osip and Nadezhda Mandel'shtam, Anna Akhmatova, Wallace Stevens, Ezra Pound, and J. H. Prynne—construct utopias of one within and against modernity's two large-scale attempts to harmonize individual and collective interests: liberalism and communism. The book begins in the United States between the buildup to the Civil War and the end of Jim Crow; continues in the Soviet Union between Stalinism and the late Soviet period; and concludes in England and the United States between World War I and the end of the Cold War. In this way it captures how writers from disparate geopolitical contexts resist state and normative power to construct perfect worlds—for themselves alone. The book contributes to debates about literature and politics, presenting innovative arguments about aesthetic difficulty, personal autonomy, and complicity and dissent. It models a new approach to transnational and comparative scholarship, combining original research in English and Russian to illuminate more than a century and a half of literary and political history.

Situational Breakdowns

2019 ◽  
Author(s):  
Anne Nassauer
Keyword(s):  
United States ◽  
Large Scale ◽  
Contextual Factors ◽  
The United States ◽  
Social Outcomes ◽  
Dynamic Processes ◽  
Collective Decisions ◽  
Different Types ◽  
The Impact

This book provides an account of how and why routine interactions break down and how such situational breakdowns lead to protest violence and other types of surprising social outcomes. It takes a close-up look at the dynamic processes of how situations unfold and compares their role to that of motivations, strategies, and other contextual factors. The book discusses factors that can draw us into violent situations and describes how and why we make uncommon individual and collective decisions. Covering different types of surprise outcomes from protest marches and uprisings turning violent to robbers failing to rob a store at gunpoint, it shows how unfolding situations can override our motivations and strategies and how emotions and culture, as well as rational thinking, still play a part in these events. The first chapters study protest violence in Germany and the United States from 1960 until 2010, taking a detailed look at what happens between the start of a protest and the eruption of violence or its peaceful conclusion. They compare the impact of such dynamics to the role of police strategies and culture, protesters’ claims and violent motivations, the black bloc and agents provocateurs. The analysis shows how violence is triggered, what determines its intensity, and which measures can avoid its outbreak. The book explores whether we find similar situational patterns leading to surprising outcomes in other types of small- and large-scale events: uprisings turning violent, such as Ferguson in 2014 and Baltimore in 2015, and failed armed store robberies.

Ban Ki-moon, 2007–2016

2018 ◽  
Author(s):  
Richard Gowan
Keyword(s):  
United States ◽  
Decision Making ◽  
Security Council ◽  
Large Scale ◽  
Central African Republic ◽  
The United States ◽  
Cautious Approach ◽  
Peacekeeping Operations ◽  
Council Decision ◽  
The Face

During Ban Ki-moon’s tenure, the Security Council was shaken by P5 divisions over Kosovo, Georgia, Libya, Syria, and Ukraine. Yet it also continued to mandate and sustain large-scale peacekeeping operations in Africa, placing major burdens on the UN Secretariat. The chapter will argue that Ban initially took a cautious approach to controversies with the Council, and earned a reputation for excessive passivity in the face of crisis and deference to the United States. The second half of the chapter suggests that Ban shifted to a more activist pressure as his tenure went on, pressing the Council to act in cases including Côte d’Ivoire, Libya, and Syria. The chapter will argue that Ban had only a marginal impact on Council decision-making, even though he made a creditable effort to speak truth to power over cases such as the Central African Republic (CAR), challenging Council members to live up to their responsibilities.

Regulating Medical Devices in the United States

2020 ◽  
Author(s):  
Patricia J. Zettler ◽  
Erika Lietzan
Keyword(s):  
United States ◽  
Medical Device ◽  
Medical Devices ◽  
Complete Information ◽  
The United States ◽  
Risk Level ◽  
Management Tools ◽  
Medical Technologies ◽  
The Us ◽  
Medical Device Regulation

This chapter assesses the regulation of medical devices in the United States. The goal of the US regulatory framework governing medical devices is the same as the goal of the framework governing medicines. US law aims to ensure that medical devices are safe and effective for their intended uses; that they become available for patients promptly; and that manufacturers provide truthful, non-misleading, and complete information about the products. US medical device law is different from US medicines law in many ways, however, perhaps most notably because most marketed devices do not require pre-market approval. The chapter explores how the US Food and Drug Administration (FDA) seeks to accomplish its mission with respect to medical devicecough its implementation of its medical device authorities. It starts by explaining what constitutes a medical device and how the FDA classifies medical devices by risk level. The chapter then discusses how medical devices reach the market, the FDA's risk management tools, and the rules and incentives for innovation and competition. It concludes by exploring case studies of innovative medical technologies that challenge the traditional US regulatory scheme to consider the future of medical device regulation.

scholarly journals 1068. Large-Scale Migration and the Changing Viral Hepatitis Prevalences in North America: A modeling approach

2020 ◽  
Vol 7 (Supplement_1) ◽  
pp. S563-S563
Author(s):  
Kenneth A Valles ◽  
Lewis R Roberts
Keyword(s):  
United States ◽  
Viral Hepatitis ◽  
Large Scale ◽  
Country Of Origin ◽  
Human Movement ◽  
High Volume ◽  
The United States ◽  
The Philippines ◽  
Outcome Data ◽  
Treatment Programs

Abstract Background Infection by hepatitis B and C viruses causes inflammation of the liver and can lead to cirrhosis, liver failure, and hepatocellular carcinoma. The WHO’s ambition to eliminate viral hepatitis by 2030 requires strategies specific to the dynamic disease profiles each nation faces. Large-scale human movement from high-prevalence nations to the United States and Canada have altered the disease landscape, likely warranting adjustments to present elimination approaches. However, the nature and magnitude of the new disease burden remains unknown. This study aims to generate a modeled estimate of recent HBV and HCV prevalence changes to the United States and Canada due to migration. Methods Total migrant populations from 2010-2019 were obtained from United Nations Migrant Stock database. Country-of-origin HBV and HCV prevalences were obtained for the select 40 country-of-origin nations from the Polaris Observatory and systematic reviews. A standard pivot table was used to evaluate the disease contribution from and to each nation. Disease progression estimates were generated using the American Association for the Study of the Liver guidelines and outcome data. Results Between 2010 and 2019, 7,676,937 documented migrants arrived in US and Canada from the selected high-volume nations. Primary migrant source regions were East Asia and Latin America. Combined, an estimated 878,995 migrants were HBV positive, and 226,428 HCV positive. The majority of both migrants (6,477,506) and new viral hepatitis cases (HBV=840,315 and HCV=215,359) were found in the United States. The largest source of HBV cases stemmed from the Philippines, and HCV cases from El Salvador. Conclusion Massive human movement has significantly changed HBV and HCV disease burdens in both the US and Canada over the past decade and the long-term outcomes of cirrhosis and HCC are also expected to increase. These increases are likely to disproportionally impact individuals of the migrant and refugee communities and screening and treatment programs must be strategically adjusted in order to reduce morbidity, mortality, and healthcare expenses. Disclosures All Authors: No reported disclosures

Are Americans less likely to reply to emails from Black people relative to White people?

2021 ◽  
Vol 118 (52) ◽  
pp. e2110347118
Author(s):  
Ray Block ◽  
Charles Crabtree ◽  
John B. Holbein ◽  
J. Quin Monson
Keyword(s):  
United States ◽  
Large Scale ◽  
Black People ◽  
Racial Bias ◽  
The United States ◽  
Simple Task ◽  
The Public ◽  
Medical Sector ◽  
Large Scale Field ◽  
Ethnic Subgroups

In this article, we present the results from a large-scale field experiment designed to measure racial discrimination among the American public. We conducted an audit study on the general public—sending correspondence to 250,000 citizens randomly drawn from public voter registration lists. Our within-subjects experimental design tested the public’s responsiveness to electronically delivered requests to volunteer their time to help with completing a simple task—taking a survey. We randomized whether the request came from either an ostensibly Black or an ostensibly White sender. We provide evidence that in electronic interactions, on average, the public is less likely to respond to emails from people they believe to be Black (rather than White). Our results give us a snapshot of a subtle form of racial bias that is systemic in the United States. What we term everyday or “paper cut” discrimination is exhibited by all racial/ethnic subgroups—outside of Black people themselves—and is present in all geographic regions in the United States. We benchmark paper cut discrimination among the public to estimates of discrimination among various groups of social elites. We show that discrimination among the public occurs more frequently than discrimination observed among elected officials and discrimination in higher education and the medical sector but simultaneously, less frequently than discrimination in housing and employment contexts. Our results provide a window into the discrimination that Black people in the United States face in day-to-day interactions with their fellow citizens.

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