scholarly journals Opportunities for Regulatory Changes to Promote Pediatric Device Innovation in the United States: Joint Recommendations from Pediatric Innovator Roundtables, August 5, 2020 & January 6, 2021

2021 ◽  
pp. 1-1
Author(s):  
Terence Sanger ◽  
Anthony Chang ◽  
William Feaster ◽  
Sharief Taraman ◽  
Nadine Afari ◽  
...  
Keyword(s):  
United States ◽  
The United States ◽  
Regulatory Changes

scholarly journals The United States’ Regulatory Environment Is Evolving to Accommodate a Coming Boom in Gene Therapy Research

2019 ◽  
Vol 24 (3) ◽  
pp. 147-152 ◽  
Author(s):  
Daniel Eisenman
Keyword(s):  
United States ◽  
Gene Therapy ◽  
Clinical Trials ◽  
The United States ◽  
Regulatory Environment ◽  
Evidence Based ◽  
Regulatory Structure ◽  
Regulatory Changes ◽  
Current State ◽  
Therapy Field

Introduction: A dramatic increase in the number of clinical trials involving gene-modified cell therapy and gene therapy is taking place. The field is on the verge of a boom, and the regulatory environment is evolving to accommodate the growth. Discussion: This commentary summarizes the current state of the field, including an overview of the growth. The United States (US) regulatory structure for gene therapy will be summarized, and the evolution of the oversight structure will be explained. Conclusion: The gene therapy field has recently produced its first FDA-approved therapeutics and has a pipeline of other investigational products in the final stages of clinical trials before they can be evaluated by the FDA as safe and effective therapeutics. As research continues to evolve, so must the oversight structure. Biosafety professionals and IBCs have always played key roles in contributing to the safe, evidence-based advancement of gene therapy research. With the recent regulatory changes and current surge in gene therapy research, the importance of those roles has increased dramatically.

scholarly journals Labeling of genetically modified food: Closer to reality in the United States?

2013 ◽  
Vol 32 (1) ◽  
pp. 73-84 ◽  
Author(s):  
Anton E. Wohlers
Keyword(s):  
United States ◽  
Genetically Modified ◽  
The United States ◽  
Food Labeling ◽  
Genetically Modified Food ◽  
Policy Debate ◽  
Gm Food ◽  
Regulatory Changes ◽  
Gm Animals ◽  
Near Future

Within the broader context of several related biotech developments, including the proliferation of GM food in American grocery stories, the recent decision by Whole Foods Market, Inc. to require the labeling of all genetically modified (GM) organism products sold in its stores by 2018, and the development of GM animals for consumption, this essay asks whether the United States is inching towards a policy of mandatory GM food labeling. The analysis highlights aspects of the biotechnology policy debate in the United States and European Union, and traces public opinion as well as grassroots and legislative efforts aimed at GM food labeling. Findings show that activities at the federal level do not suggest any major regulatory changes regarding labeling in the near future; however, a growing number of individual states are considering GM food labeling legislation and political momentum in favor of labeling has picked up in recent years. Voluntary labeling by food companies may also become increasingly common.

The Advent of a New Banking System in the US

2021 ◽  
pp. 24-46
Author(s):  
João Rafael Cunha
Keyword(s):  
United States ◽  
Great Depression ◽  
Banking Sector ◽  
Banking System ◽  
Financial System ◽  
The United States ◽  
Financial Deregulation ◽  
The Great Depression ◽  
Regulatory Changes ◽  
The Us

The 1980s was one of the most eventful and consequential decades in the development of the US financial system. During this decade, the regulatory framework established in response to the Great Depression started to be dismantled. These regulatory changes were a key driving force behind the transformation of the banking sector. Moreover, the end of the decade saw the most serious banking crisis since the Great Depression. This pattern of deregulation and crises, which started in the 1980s, has continued until the present. Thus, it is worth study this period in greater detail and the consequences it has had for the US banking and financial system. The chapter argues that the deregulatory process that started in the 1980s in the banking industry in the United States has changed the profile of this sector. Between the Great Depression and the 1980s, the banking sector in the United States was a stable, yet not competitive sector. The financial deregulation of the 1980s changed this sector to a competitive, yet unstable one. This deregulatory process occurred mostly as a response to the economic conditions of the 1970s.

scholarly journals Whole Farm Water Use: A Survey of Vegetable Producers in New England States | 2018

2018 ◽  
Author(s):  
Rachel Schattman ◽  
Vern Grubinger ◽  
Lisa McKaeg ◽  
Katie Nelson
Keyword(s):  
Public Health ◽  
United States ◽  
New England ◽  
Risk Mitigation ◽  
The United States ◽  
Hazard Identification ◽  
Northeastern United States ◽  
Safety Hazard ◽  
Produce Safety ◽  
Regulatory Changes

Produce safety and climate change are two overlapping risks that face vegetable producers in the northeastern United States. Because of recent public health outbreaks (and subsequent litigation) traced back to fresh produce, food safety hazard identification and risk mitigation has become the focus of significant regulatory changes in the United States (FDA 2015)

scholarly journals Financialization of Non-financial Industries, United States, 1980-2006

2020 ◽  
Vol 11 (5) ◽  
pp. 72
Author(s):  
Youn Ki ◽  
Misung Ahn
Keyword(s):  
United States ◽  
Explanatory Power ◽  
The United States ◽  
Factor Intensity ◽  
Financial Firms ◽  
Industry Level ◽  
Regulatory Changes ◽  
Level Analysis ◽  
Oriented Research

Non-financial firms have become substantially dependent on financial revenues. However, the timing and intensity of financialization vary by industry. We investigate variation in the level of financialization among different non-financial industries in the United States from 1980 to 2006. We first illustrate how unique incidents and regulatory changes influenced different industries’ financialization trajectories. We also conduct a statistical analysis to examine three types of industry-level determinants: profitability, uncertainty, and factor intensity. We find that these determinants have high explanatory power regarding interindustry variation in financialization. An industry-level analysis allows us to better understand the role of historical, institutional, and industrial factors in the financialization process which have been overlooked in structure-oriented research.

Is the Push for More Prescriptive Regulation Making Us Less Safe?

2018 ◽  
Author(s):  
Charlene B. Wright ◽  
Mark S. Jean
Keyword(s):  
United States ◽  
The United States ◽  
Unintended Consequences ◽  
Federal State ◽  
The Public ◽  
High Profile ◽  
Regulatory Changes ◽  
Safety Regulations ◽  
Industry Standards ◽  
Oil And Natural Gas

Current pipeline regulations in North America have changed significantly over the past several decades and will continue to change as public and regulatory scrutiny intensifies and new industry standards are developed (i.e. API RP 1173). As regulators assess the approach to take, they are increasingly looking at what other regulators are doing in their respective jurisdictions, including those at federal, state and provincial levels. Despite historical commitments to conceptual models fostering cooperation between regulators and regulated entities, recent trends in the United States signify a departure from performance or outcome-based regulation toward a more prescriptive approach. Pipelines remain the safest method of transporting oil and natural gas.1 However, when pipeline incidents do occur, the consequences can be catastrophic and are often well publicized. Federal and state regulators are under increased pressure in the aftermath of high-profile incidents to assuage the concerns of legislators and the public at large. This paper generally compares various regulatory models and the relative benefits and drawbacks of each. A more in-depth review of regulatory changes in the United States is examined, to analyze the potential intended and unintended consequences of the move towards more prescriptive pipeline safety regulations.

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