Regulatory Decision‐Making in the United States Based on a Single Pivotal Clinical Study: Principles and Precedents

2004 ◽  
Vol 21 (2) ◽  
pp. 101-143 ◽  
Author(s):  
David M. Cocchetto
Author(s):  
Mariano-Florentino Cuéllar ◽  
Jerry L. Mashaw

The economic analysis of regulation is a broad topic, with implications for environmental protection, communications and technology policy, public health, immigration, national security, and other areas affecting risk and welfare in society. This chapter covers only a portion of the relevant ground, focusing on the following essential topics: First, what do we mean by “economic analysis” and what do we mean by “regulation”? Second, why has this topic become an important one, not only the United States, but in most advanced democracies? Third, why is economic analysis and regulation a contested, even contentious, aspect of modern regulatory activity? Finally, and most important, how is economic analysis structured into regulatory decision-making, and how might existing arrangements evolve over time?


2021 ◽  
Vol 20 (1) ◽  
pp. 64-69
Author(s):  
M. A. Borzova ◽  
А. S. Kolbin

The article describes the legal basis for the application of real-world data to support regulatory decision-making in the United States, as well as the possibility of implementing the relevant approaches in the legislation of the Eurasian Economic Union.


Cytotherapy ◽  
2018 ◽  
Vol 20 (6) ◽  
pp. 769-778 ◽  
Author(s):  
D.G.M. Coppens ◽  
S. de Wilde ◽  
H.J. Guchelaar ◽  
M.L. De Bruin ◽  
H.G.M. Leufkens ◽  
...  

1990 ◽  
Vol 6 (5) ◽  
pp. 245-255 ◽  
Author(s):  
Si Duk Lee

Noncriteria air pollutants are synonymous with hazardous air pollutants (HAPs), air toxics or toxic air pollutants (TAPs). The term noncriteria pollutants refers to all air pollutants except for the criteria pollutants (SOx, PM, NOx, CO, O3, and Pb). Air toxics are pervasive in our environment worldwide in varying degrees. Uses of these chemicals are varied and numerous; their emissions are ubiquitous, and they include organic compounds such as chlorinated hydrocarbons, dioxins, aldehydes, polynuclear aromatic hydrocarbons, and heavy metals such as chromium, nickel, cadmium, and mercury. There are more than 70,000 chemicals that are in use commercially in the United States, and we know relatively little about their ambient concentrations, persistence, transport and transformation as well as their effects on health and the environment, many of which take decades to emerge. The United States Environmental Protection Agency, under the authority of Section 112 of the Clean Air Act, is mandated to regulate any air pollutant which, in the Administrator's judgment, “causes, or contributes to, air pollution which may reasonably be anticipated to result in an increase in serious irreversible or incapacitating reversible illness.” For such regulatory decision-making, EPA's Office of Health and Environmental Assessment (OHEA) provides scientific assessment of health effects for potentially hazardous air pollutants. In accordance with risk assessment guidelines developed by OHEA over the years, Health Assessment Documents (HADs) containing risk assessment information were prepared and were subjected to critical review and careful revision to produce Final Draft HADs which serve as scientific databases for regulatory decision-making by the Office of Air Quality Planning and Standards (OAQPS) in its risk management process. EPA developed databases such as the Integrated Risk Information System (IRIS) and the National Air Toxics Information Clearinghouse (NATICH) and a technical assistance response system called the Air Risk Information Support Center (AIR RISC), in addition, to help in implementation of the National Air Toxics Program by state and local regulators.


Author(s):  
Steven Hurst

The United States, Iran and the Bomb provides the first comprehensive analysis of the US-Iranian nuclear relationship from its origins through to the signing of the Joint Comprehensive Plan of Action (JCPOA) in 2015. Starting with the Nixon administration in the 1970s, it analyses the policies of successive US administrations toward the Iranian nuclear programme. Emphasizing the centrality of domestic politics to decision-making on both sides, it offers both an explanation of the evolution of the relationship and a critique of successive US administrations' efforts to halt the Iranian nuclear programme, with neither coercive measures nor inducements effectively applied. The book further argues that factional politics inside Iran played a crucial role in Iranian nuclear decision-making and that American policy tended to reinforce the position of Iranian hardliners and undermine that of those who were prepared to compromise on the nuclear issue. In the final chapter it demonstrates how President Obama's alterations to American strategy, accompanied by shifts in Iranian domestic politics, finally brought about the signing of the JCPOA in 2015.


Author(s):  
Richard Gowan

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.


Prospects ◽  
1988 ◽  
Vol 13 ◽  
pp. 181-223 ◽  
Author(s):  
Howard P. Segal

“Technology Spurs Decentralization Across the Country.” So reads a 1984 New York Times article on real-estate trends in the United States. The contemporary revolution in information processing and transmittal now allows large businesses and other institutions to disperse their offices and other facilities across the country, even across the world, without loss of the policy- and decision-making abilities formerly requiring regular physical proximity. Thanks to computers, word processors, and the like, decentralization has become a fact of life in America and other highly technological societies.


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