The Office of Information and Regulatory Affairs and the durability of regulatory oversight in the United States

2020 ◽  
Author(s):  
Susan E. Dudley
Keyword(s):  
United States ◽  
The United States ◽  
Regulatory Oversight ◽  
Regulatory Affairs

Safe until Sorry

2018 ◽  
Author(s):  
Norah MacKendrick
Keyword(s):  
United States ◽  
Precautionary Principle ◽  
Consumer Goods ◽  
Food Production ◽  
Personal Care Products ◽  
The United States ◽  
Policy Framework ◽  
Personal Care ◽  
Regulatory Oversight ◽  
Agriculture And Food

This chapter outlines the United States’ uneven and contradictory relationship with the precautionary principle as a policy ethic, and, more specifically points to how the safe-until-sorry model at the regulatory level helps to explain why precaution has flourished as an individualized, consumer principle. In outlining this relationship, it documents the serious gaps in regulatory oversight in what is a vast, fractured policy framework that oversees chemicals used in agriculture and food production, and in the manufacturing of cosmetics, personal care products and consumer goods.

Book Reviews

2010 ◽  
Vol 48 (4) ◽  
pp. 1051-1053
Keyword(s):  
United States ◽  
Law And Economics ◽  
The United States ◽  
The European Union ◽  
Regulatory Oversight ◽  
Industrial Economics ◽  
Law And Technology ◽  
Economic Perspectives ◽  
The University

Joacim Tag of Research Institute of Industrial Economics reviews “Antitrust and Regulation in the EU and US: Legal and Economic Perspectives” by Francois Leveque, Howard Shelanski, Francois Leveque, Howard Shelanski,. The EconLit Abstract of the reviewed work begins “Seven papers, originally presented at the “Balancing Antitrust and Regulation in Network Industries: Evolving Approaches in Europe and the United States” conference jointly organized by CERNA and the Berkeley Center for Law and Technology and held in Paris in January 2006, address various aspects of the evolving balance between antitrust and regulation in the European Union and the United States. Papers discuss synthetic competition (Douglas H. Ginsburg); European competition policy and regulation--differences, overlap, and contraints (John Temple Lang); contrasting legal solutions and the comparability of EU and U.S. experiences (Pierre Larouche); modeling an antitrust regulator for telecoms (James B. Speta); rethinking merger remedies--toward a harmonization of regulatory oversight with antitrust merger review (Philip J. Weiser); market power in U.S. and EU electricity generation (Richard Gilbert and David Newbery); and mobile call termination--a tale of two-sided markets (Tommaso Valletti). Leveque is Professor of Law and Economics at Ecole des mines de Paris. Shelanski is Professor of Law in the School of Law at the University of California, Berkeley. Index.”

A Defense of Limited Regulation of Human Genetic Therapies

2018 ◽  
Vol 28 (1) ◽  
pp. 112-120 ◽  
Author(s):  
JAMES J. HUGHES
Keyword(s):  
United States ◽  
Human Subjects ◽  
The United States ◽  
National Institutes Of Health ◽  
Regulatory Agencies ◽  
Cultural Norms ◽  
Regulatory Oversight ◽  
Reproductive Freedom ◽  
Gene Therapies ◽  
Genetic Technologies

Abstract:There is a role for regulatory oversight over new genetic technologies. Research must ensure the rights of human subjects, and all medical products and techniques should be ensured to be safe and effective. In the United States, these forms of regulation are largely the purview of the National Institutes of Health and the Food and Drug Administration. Some have argued, however, that human genetic therapies require new regulatory agencies empowered to enforce cultural norms, protect against hypothetical social harms, or ensure that the human genome remains unchanged. Focusing on the United States, this essay will briefly review these arguments and argue that the current limited regulatory role over human gene therapies is sufficient to protect public health, bodily autonomy, and reproductive freedom.

scholarly journals Preventing Prescription Drug Misuse: A Regulatory Perspective in the United States, Europe, and India

2021 ◽  
Vol 9 (4) ◽  
pp. 46-52
Author(s):  
Dhruvi B Thakker ◽  
Kalpana G Patel
Keyword(s):  
United States ◽  
Regulatory System ◽  
The United States ◽  
Drug Misuse ◽  
Prescription Drug Misuse ◽  
Regulatory Oversight ◽  
Pharmaceutical Supply Chain ◽  
Post Marketing Surveillance ◽  
Post Marketing ◽  
The Times

Prescription medicines, such as analgesics, stimulants, steroids, anti-depressants, psychotropics, and certain antibiotics are commonly mishandled in a variety of ways, including overdosing, abuse, diversion, and drug trafficking. Because of the considerable risk to public health, they are subject to strict regulatory oversight. The drugs possess abuse potential at specific dose and hence prone to abuse therefore they are categorized as Controlled substances. Therefore, they are subject to constant vigilance over the pharmaceutical supply chain. The complete clinical data as well as post marketing surveillance study of such drugs are critical to be in place as per the regulatory requirements. The countries have kept up with the times by constantly updating the system with regulatory laws and strategies to prevent cases of misuse. The current review will give a quick summary of how prescription medications and prohibited substances are regulated in the United States, Europe, and India. It will also emphasize current trends in drug usage, as well as the issues that these countries face and the preventive policies implemented to manage and prevent drug misuse. It will also make recommendations for new regulatory initiatives to address the current drug- misuse-related concerns. As a result, a review of the regulatory system in various countries will present current challenges and new lessons for countries around the globe.

Global Markets, National Toolkits

2018 ◽  
Author(s):  
Matthew Gravelle ◽  
Stefano Pagliari
Keyword(s):  
United States ◽  
European Union ◽  
The United States ◽  
Global Markets ◽  
The European Union ◽  
Regulatory Oversight ◽  
Land Grab ◽  
Regulatory Authorities ◽  
Otc Derivatives ◽  
Derivatives Markets

A key trend that has characterized implementation of the international agenda to regulate derivatives has been the emergence of a number of disputes over the territorial scope of regulation, as different countries have sought to extend their regulatory oversight over firms and markets that are not legally domiciled in their jurisdiction. What explains the emergence and continuation of these extraterritorial measures in the regulation of global OTC derivatives markets? This chapter addresses this question by exploring the “regulatory land grab” that has characterized the rules introduced in the United States and the European Union to regulate foreign dealers, CCPs, and trading venues. This chapter will argue that the different degrees of extraterritoriality that have emerged in the post-crisis agenda reflect the challenges that regulatory authorities have faced to implement the new prudential agenda in a manner that addresses the highly internationalized nature of derivatives markets.

scholarly journals Aviation Approach Charts in an iPad® World

2012 ◽  
Vol 66 (1) ◽  
pp. 135-147
Author(s):  
William A. Tuccio
Keyword(s):  
United States ◽  
Historical Context ◽  
The United States ◽  
Government Agency ◽  
Mobile Technologies ◽  
Safety Hazards ◽  
Regulatory Oversight ◽  
New Methods ◽  
Financial Interest ◽  
Electronic Chart

The process used to create charted depictions of aviation instrument approach procedures in the United States is examined. The rapid growth of iPad®-like mobile technologies is discussed relative to the historical context of chart implementation. Notional new methods of electronic chart generation are introduced, demonstrating both the functional possibilities and concerns not directly addressed by existing regulation for private aircraft operators. These concerns suggest a ‘yin-yang’ of the stifling of innovation versus the creation of latent safety hazards. The article concludes by recommending regulatory oversight review of approach chart implementation. A glossary of terms is included at the end of this paper. The facts, analysis, and opinions offered in this article represent an independent effort of the author and do not reflect the opinions of any academic institution or government agency. The author also has a limited financial interest in certain iOS® applications.

scholarly journals Governing gene editing in agriculture and food in the United States

Elem Sci Anth ◽  
2021 ◽  
Vol 9 (1) ◽  
Author(s):  
Theresa Selfa ◽  
Sonja Lindberg ◽  
Carmen Bain
Keyword(s):  
United States ◽  
Gene Editing ◽  
Self Regulation ◽  
The United States ◽  
Nonstate Actors ◽  
Regulatory Oversight ◽  
Commodity Group ◽  
Semistructured Interviews ◽  
Environmental Nongovernmental Organizations ◽  
Agriculture And Food

Biotechnologies in agriculture and food are increasingly governed by both state and nonstate actors. In this article, we explore emerging tensions and contestations in the United States over how gene-editing technologies in agriculture and food should be governed and by whom. This article is framed theoretically by the literatures examining the politics of state and nonstate governance of the agrifood and biotechnology sectors. We draw on semistructured interviews with 45 key actors in the United States, including representatives of regulatory agencies, commodity groups, consumer and environmental nongovernmental organizations (NGOs), biotechnology and food industry, and scientists. In contrast to assumptions that commodity group and industry actors would share a preference for limited or self-regulation, we find growing contestations, with some calling for novel forms of regulatory oversight. Our findings reveal new tensions, fractures, and realignments between and among government, industry, and NGOs actors over gene-editing governance. These tensions and realignments reflect and respond to demands for broader engagement of publics and greater transparency in the governance of biotechnologies in agriculture and food. We argue that these emerging tensions and realignments between and among state and nonstate actors reflect efforts by these actors to incorporate lessons from the genetically modified organism labeling fight as they seek to (re)shape the governance of gene editing in a manner that reflects their interests.

Understanding and Contributing to the Enigma of Corporate Social Responsibility (CSR) Assurance in the United States

2014 ◽  
Vol 34 (1) ◽  
pp. 97-130 ◽  
Author(s):  
Ryan J. Casey ◽  
Jonathan H. Grenier
Keyword(s):  
United States ◽  
Corporate Social Responsibility ◽  
Social Responsibility ◽  
The United States ◽  
Equity Capital ◽  
Forecast Errors ◽  
Cost Of Equity Capital ◽  
Regulatory Oversight ◽  
Empirical Examination ◽  
Corporate Social

SUMMARY This paper provides an empirical examination of the corporate social responsibility (CSR) assurance market in the United States. Various constituencies have found this market puzzling, as the level of assurance significantly lags international levels (Simnett et al. 2009; KPMG 2011). Results shed light on this enigma by demonstrating that, unlike their international counterparts, U.S. finance and utilities firms are not more likely (than firms in other industries) to obtain CSR assurance despite facing significant social and environmental risks. As these industries are highly regulated in the United States, regulatory oversight may be acting as a substitute for CSR assurance. We also find that highly leveraged firms are less likely to obtain CSR assurance, potentially due to stringent bank monitoring indirectly suppressing demand. Nonetheless, examining the capital market responses to CSR assurance makes the low demand even more puzzling. Specifically, CSR assurance is associated with lower cost of equity capital along with lower analyst forecast errors and dispersion. Furthermore, the reductions in cost-of-capital and forecast dispersion are significantly higher when CSR assurance is provided by an accounting firm. These results have implications for companies that are considering CSR assurance and accounting firms in developing and marketing their CSR assurance services.

scholarly journals Product Registration and Regulatory Change

1984 ◽  
Vol 3 (2) ◽  
pp. 125-128
Author(s):  
Patricia D. Royal
Keyword(s):  
United States ◽  
Quality Assurance ◽  
The United States ◽  
Regulatory Change ◽  
Test Standards ◽  
Regulatory Affairs ◽  
Good Laboratory ◽  
Practical Sense

The enactment of the FDA Good Laboratory Practices (GLPs) into law by the FDA has led to major changes throughout industrial toxicology programs. One major addition to toxicology studies, as specified in the GLPs, includes the requirement of a quality assurance (QA) program. Initially, the role of QA was that of monitor or auditor. This role has expanded in a practical sense, however, to include a working knowledge of regulatory affairs and principles of toxicology. Since 1978, new GLPs and test standards have been issued by several countries, including the United States. The requirements and guidelines set forth by various countries, while similar in content, are different in their specific details. The development of comprehensive, scientifically sound protocols to meet these new requirements necessitates a continual assessment of the regulations in effect in the countries where registration is sought. Thus, the role of QA has expanded to include the assessment of guidelines and protocols to assure that toxicology studies conducted to support registration are in compliance with these guidelines.

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