Evidence, in Context: A Regulatory Perspective on Pharmacogenetics

Author(s):  
Michael Pacanowski ◽  
Robert N. Schuck
2011 ◽  
Vol 9 (1-2) ◽  
pp. 43-50 ◽  
Author(s):  
Julia Liou ◽  
Catherine Porter ◽  
Thu Quach

The nail salon sector is growing rapidly. Nail salon workers are predominantly Vietnamese immigrant women who are exposed to numerous harmful chemicals in nail care products. The situation is exacerbated by limited safety information, language barriers to information, and lack of government oversight. This brief discusses the health and safety issues faced by workers at the nexus of environmental and worker justice and the policy recommendations by which to address these issues from a public health and regulatory perspective. Although these policy recommendations pertain to California where the sector is largest, they also have far-reaching implications at the national level.


2016 ◽  
Vol 23 (12) ◽  
pp. 1052-1060 ◽  
Author(s):  
Bert Gevaert ◽  
Lieselotte Veryser ◽  
Frederick Verbeke ◽  
Evelien Wynendaele ◽  
Bart Spiegeleer

2019 ◽  
Vol 24 (42) ◽  
pp. 5081-5083 ◽  
Author(s):  
Mohd. A. Mirza ◽  
Zeenat Iqbal

Background: The last few decades have witnessed enormous advancements in the field of Pharmaceutical drug, design and delivery. One of the recent developments is the advent of 3DP technology. It has earlier been successfully employed in fields like aerospace, architecture, tissue engineering, biomedical research, medical device and others, has recently forayed into the pharmaceutical industry.Commonly understood as an additive manufacturing technology, 3DP aims at delivering customized drug products and is the most acceptable form of“personalized medicine”. Methods: Data bases and search engines of regulatory agencies like USFDA and EMA have been searched thoroughly for relevant guidelines and approved products. Other portals like PubMed and Google Scholar were also ferreted for any relevant repository of publications are referred to wherever required. Results: So far only one pharmaceutical product has been approved in this category by USFDA and stringent regulatory agencies are working over the drafting of guidelines and technical issues. Major research of this category belongs to the academic domain. Conclusion: It is also implicit to such new technologies that there would be numerous challenges and doubts before these are accepted as safe and efficacious. The situation demands concerted and cautious efforts to bring in foolproof regulatory guidelines which would ultimately lead to the success of this revolutionary technology.


2016 ◽  
Vol 30 (3) ◽  
pp. 379-392 ◽  
Author(s):  
Jared Eutsler ◽  
Erin Burrell Nickell ◽  
Sean W. G. Robb

SYNOPSIS Prior research indicates that issuing a going concern opinion to financially stressed clients generally reduces the risk of litigation against the auditor following a bankruptcy (Kaplan and Williams 2013; Carcello and Palmrose 1994). However, we propose that a going concern report may indicate prior knowledge of financial distress, an important fraud risk factor, and this may have repercussions for the auditor if a fraud is subsequently uncovered. Consistent with counterfactual reasoning theory, experimental research suggests that a documented awareness of fraud risk actually increases the likelihood of litigation against the auditor following a fraud (Reffett 2010). This concern has been echoed by the professional community (AICPA 2004; Golden, Skalak, and Clayton 2006) and may be exacerbated by the current outcome-based regulatory environment (Peecher, Solomon, and Trotman 2013). To examine this issue we review Auditing and Accounting Enforcement Releases (AAERs) issued by the Securities and Exchange Commission (SEC) for alleged financial reporting frauds between 1995 and 2012. Results suggest that going concern report modifications accompanying the last set of fraudulently stated financials are associated with a greater likelihood of enforcement action against the auditor. This finding is consistent with counterfactual reasoning theory and suggests that, from a regulatory perspective, auditors may be penalized for documenting their awareness of fraud risk when financial statements are later determined to be fraudulent.


Antibiotics ◽  
2021 ◽  
Vol 10 (6) ◽  
pp. 648
Author(s):  
Michela Pugliese ◽  
Vito Biondi ◽  
Enrico Gugliandolo ◽  
Patrizia Licata ◽  
Alessio Filippo Peritore ◽  
...  

Chelant agents are the mainstay of treatment in copper-associated hepatitis in humans, where D-penicillamine is the chelant agent of first choice. In veterinary medicine, the use of D-penicillamine has increased with the recent recognition of copper-associated hepatopathies that occur in several breeds of dogs. Although the different regulatory authorities in the world (United States Food and Drugs Administration—U.S. FDA, European Medicines Agency—EMEA, etc.) do not approve D-penicillamine for use in dogs, it has been used to treat copper-associated hepatitis in dogs since the 1970s, and is prescribed legally by veterinarians as an extra-label drug to treat this disease and alleviate suffering. The present study aims to: (a) address the pharmacological features; (b) outline the clinical scenario underlying the increased interest in D-penicillamine by overviewing the evolution of its main therapeutic goals in humans and dogs; and finally, (c) provide a discussion on its use and prescription in veterinary medicine from a regulatory perspective.


2020 ◽  
Vol 4 (Supplement_1) ◽  
pp. 726-727
Author(s):  
Diana White ◽  
Tunalilar Ozcan ◽  
Serena Hasworth ◽  
Jaclyn Winfree

Abstract Quality is defined in multiple ways and by different stakeholders (e.g., residents, regulators, informed observers). Using a two-stage stratified sampling strategy, we collected data from N=241 residents living in 31 assisted living and residential care communities (AL/RC) in Oregon. Residents rated their overall satisfaction and satisfaction with the AL/RC as a place to live and to receive care. Each interviewer completed a facility profile summarizing their observations about the setting, including quality of staff-resident interactions and physical environment. Residents and interviewers were also asked whether they would recommend the community to others. Finally, we used deficiency citations given during regular inspections by the licensing agency to proxy regulatory perspective. Results show that perceived quality varied by stakeholder (e.g., residents’ assessments differed from deficiency citations). Given this variation, findings suggest that efforts to make quality indicators publicly available should include multiple measures and perspectives, especially residents.


2021 ◽  
Vol 141 ◽  
pp. 105352
Author(s):  
Brian H.W. Guo ◽  
Rory Weston ◽  
Paul Jianphinitnan ◽  
Wanjun Liu ◽  
Eric Scheepbouwer ◽  
...  

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