Barack Obama's Path to Progress in 2015-16: Thirteen Essential Regulatory Actions

2014 ◽  
Author(s):  
Rena I. Steinzor ◽  
James Goodwin ◽  
Matthew Shudtz ◽  
Anne Havemann
Keyword(s):  
Regulatory Actions

scholarly journals Comprehensive evaluation of post-approval regulatory actions during the drug lifecycle – a focus on benefits and risks

2021 ◽  
pp. 1-10
Author(s):  
Lourens T. Bloem ◽  
Mariana Karomi ◽  
Jarno Hoekman ◽  
Menno E. van der Elst ◽  
Hubert G.M. Leufkens ◽  
...  
Keyword(s):  
Comprehensive Evaluation ◽  
Regulatory Actions

scholarly journals Surveillance of U.S. Corporate Filings Provides a Proactive Approach to Inform Tobacco Regulatory Research Strategy

2021 ◽  
Vol 18 (6) ◽  
pp. 3067
Author(s):  
Samantha Emma Sarles ◽  
Edward C. Hensel ◽  
Risa J. Robinson
Keyword(s):  
Electronic Cigarettes ◽  
Science Research ◽  
The United States ◽  
Regulatory Science ◽  
Product Launch ◽  
High Tech ◽  
Proactive Approach ◽  
Research Questions ◽  
The U.S ◽  
Regulatory Actions

The popularity of electronic cigarettes in the United States and around the world has led to a startling rise in youth nicotine use. The Juul® e-cigarette was introduced in the U.S. market in 2015 and had captured approximately 13% of the U.S. market by 2017. Unlike many other contemporary electronic cigarette companies, the founders behind the Juul® e-cigarette approached their product launch like a traditional high-tech start-up company, not like a tobacco company. This article presents a case study of Juul’s corporate and product development history in the context of US regulatory actions. The objective of this article is to demonstrate the value of government-curated archives as leading indicators which can (a) provide insight into emergent technologies and (b) inform emergent regulatory science research questions. A variety of sources were used to gather data about the Juul® e-cigarette and the corporations that surround it. Sources included government agencies, published academic literature, non-profit organizations, corporate and retail websites, and the popular press. Data were disambiguated, authenticated, and categorized prior to being placed on a timeline of events. A timeline of four significant milestones, nineteen corporate filings and events, twelve US regulatory actions, sixty-four patent applications, eighty-seven trademark applications, twenty-three design patents and thirty-two utility patents related to Juul Labs and its associates is presented, spanning the years 2004 through 2020. This work demonstrates the probative value of findings from patent, trademark, and SEC filing literature in establishing a premise for emergent regulatory science research questions which may not yet be supported by traditional archival research literature. The methods presented here can be used to identify key aspects of emerging technologies before products actually enter the market; this shifting policy formulation and problem identification from a paradigm of being reactive in favor of becoming proactive. Such a proactive approach may permit anticipatory regulatory science research and ultimately shorten the elapsed time between market technology innovation and regulatory response.

Impact of Antitrust and Regulatory Actions on Progress of Technology

1975 ◽  
Vol 18 (4) ◽  
pp. 7-10 ◽  
Author(s):  
Richard N. Foster ◽  
Fredrick W. Gluck
Keyword(s):  
Regulatory Actions

Regulatory Actions

2021 ◽  
pp. 11-20
Author(s):  
Bernard F. Kolanowski
Keyword(s):  
Regulatory Actions

scholarly journals Preparing Clinical Text for Use in Biomedical Research

2011 ◽  
pp. 2085-2095
Author(s):  
John P. Pestian ◽  
Lukasz Itert ◽  
Charlotte Andersen
Keyword(s):  
Language Processing ◽  
Medical Center ◽  
Clinical Care ◽  
Academic Medical Center ◽  
Clinical Text ◽  
Delivery Of Care ◽  
Radiology Reports ◽  
Academic Medical ◽  
Textual Data ◽  
Regulatory Actions

Approximately 57 different types of clinical annotations construct a patient’s medical record. These annotations include radiology reports, discharge summaries, and surgical and nursing notes. Hospitals typically produce millions of text-based medical records over the course of a year. These records are essential for the delivery of care, but many are underutilized or not utilized at all for clinical research. The textual data found in these annotations is a rich source of insights into aspects of clinical care and the clinical delivery system. Recent regulatory actions, however, require that, in many cases, data not obtained through informed consent or data not related to the delivery of care must be made anonymous (as referred to by regulators as harmless), before they can be used. This article describes a practical approach with which Cincinnati Children’s Hospital Medical Center (CCHMC), a large pediatric academic medical center with more than 761,000 annual patient encounters, developed open source software for making pediatric clinical text harmless without losing its rich meaning. Development of the software dealt with many of the issues that often arise in natural language processing, such as data collection, disambiguation, and data scrubbing.

scholarly journals Climate Adaption for Energy Utilities: Lessons Learned From California's Pioneering Regulatory Actions

2021 ◽  
Vol 3 ◽  
Author(s):  
Sonya Ziaja ◽  
Mohit Chhabra
Keyword(s):  
Climate Adaptation ◽  
Lessons Learned ◽  
Public Utilities ◽  
Regulatory Bodies ◽  
Climate Adaption ◽  
Climate Vulnerability ◽  
Energy Utilities ◽  
General Guidance ◽  
Regulatory Actions ◽  
Do So

This Policy Brief provides lessons learned from regulation of climate adaptation by energy utilities. The regulatory bodies responsible for oversight of investor-owned energy utilities are ill-equipped to regulate climate adaptation in the energy sector; but they may be the only institutions with authority to do so. In 2018, the California Public Utilities Commission initiated the first quasi-legislative procedure to regulate investor owned energy utilities' climate adaptation activities. The Commission's new rules for climate adaptation offer some general guidance on climate adaptation, and require investor owned utilities to conduct and submit climate vulnerability studies. Structural limitations, including conflicting interest, capacity of staff, and scope of the problem hampered the success of adaptation regulation, which failed to address fundamental questions about what constitutes adaptive measures.

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