Regulating Food and Drug Companies Privately: A View of Lanham Act Cases Brought Against FDA-Regulated Products

The Lanham Act provides a flexible self-help remedy to food and drug companies that are harmed by unfair competition in the marketplace. But is it desirable for private litigation to become the de facto regulation of the industry? In an FDA regulation concerning a warning on OTC drug labels, the agency asserted that “it is in the best interest of the consumer, industry, and the marketplace to have uniformity in presentation and clarity of message.â€99 However, increased regulation through private litigation can send a muddled and inconsistent message to food and drug companies. Private companies have their business interests in mind, and may even ask for damages. This is why the role of the FDA enforcement cannot be pushed aside, or replaced by private litigation. Although many of the cases discussed herein involved disputes over product claims that did not place public health at risk, ensuring truthful labeling and advertising for food and drugs nevertheless plays a vital role in protecting public health and safety

Multi-Criteria Analysis and Decision-Making Approach for the Urban Regeneration: The Application to the Rimini Canal Port (Italy)

In recent decades, urban settlements have been greatly affected by globalisation, climate change, and economic uncertainty. When designing cities, these factors should be taken into account and adapted to the different contexts involved. The redevelopment of degraded urban areas is the first step toward achieving the sustainability aims set out in the Sustainable Development Goals. In this context, evaluation methods are required in the decision-making process, considering different social, economic, and environmental aspects to define the correct policies and actions for city redevelopment. In this paper, an evaluation methodology is proposed in order to obtain a priority scale of interventions for urban regeneration. Starting from on-site inspections to better know the current scenario, a set of indicators is established to evaluate the urban quality. Criticalities and potentials emerge through SWOT analysis and, with the ANP-BOCR method, the priority scale of the identified scenarios is defined. This decision-making approach was applied to the case study of the Rimini Canal Port, in the northeast of Italy, which is a degraded area of the city. This methodology is a tool that can be used in the future by decision makers (DMs) for the redevelopment of small port areas within similar urban contexts

Predictive factors of success at the French National Ranking Examination (NRE) : a retrospective study of the student performance from a French medical school

Background The national ranking examination (NRE) marks the end of the second cycle (6th university year) of French medical studies and ranks students allowing them to choose their specialty and city of residency. We studied the potential predictive factors of success at the 2015 NRE by students attending a French School of Medicine. Methods From March 2016 to March 2017, a retrospective study of factors associated with the 2015 NRE success was conducted and enrolled 242 students who attended their sixth year at the school of medicine of Reims. Demographic and academic data collected by a home-made survey was studied using univariate and then multivariate analysis by generalized linear regression with a threshold of p <  0.05 deemed significant. Results The factors independently associated with a better ranking at the NRE were the motivation for the preparation of the NRE (gain of 3327 ± 527 places, p <  0.0001); to have participated in the NRE white test organized by la Revue du Praticien in November 2014 (gain of 869 ± 426 places, p <  0.04), to have participated in the NRE white test organized by la conférence Hippocrate in March 2015 (+ 613 places ±297, p <  0.04). The factors independently associated with poor NRE ranking were repeating the first year (loss of 1410 places ±286, p <  0.0001), repeating a year during university course (loss of 1092 places ±385, p <  0.005), attendance of hospital internships in 6th year (loss of 706 places ±298, p <  0.02). Conclusions The student motivation and their white tests completion were significantly associated with success at the NRE. Conversely, repeating a university year during their course and attendance of 6th year hospital internships were associated with a lower ranking

Variable Relationships in Online Retailing: Cultivating Consumer Satisfaction and Loyalty

In today’s competitive retailing landscape consumer satisfaction and loyalty have been key issues on the mind of many a marketer. With the growth of e-retailing, buyers and sellers have evolved; the traditional goals of satisfaction and loyalty remain but the means to achieving those have evolved with the changing online environment. As the competition continues to intensify, the costs of switching retailers remain low, and consumers adjust their spending patterns, it becomes increasingly important to provide shopping experiences of value to the consumer and to cultivate repeat purchase behavior. This paper provides a preliminary study into the interaction of various aspects of online shopping including value, trust, customer relationship management, satisfaction and how they contribute to loyalty among 18-24 year-old e-shoppers. A survey instrument was developed based on previously published work on online shopping. Respondents within the demographic were recruited and asked to respond to the questionnaire items based on a Likert scale that was provided with the survey. All responses were entered into SPPS and analyzed through correlation and regression techniques. Within the sample all hypothesized relationships were found to exist, and all aspects were found to influence loyalty, though to varying degrees. The limits of the study and the interactions with the respondents provide insight useful to subsequent and more thorough studies into this topic

Application of Mining Waste Powder as filler in Hot Mix Asphalt

Asphalt concrete mixtures are composed of two main components: aggregates and binder. The fraction of aggregates passing through the 63\u3bcm sieve is traditionally considered as filler. During years, several researches have shown the importance and the influence of filler in controlling the physical and mechanical properties of Hot Mix Asphalts (HMAs). The main objective of this research is to investigate and to assess the effects given by the use of Mining Waste Powder (MWP) within HMAs in total substitution of traditional limestone filler. The MWP used in this study is a residual of the tungsten extraction process in Panasqueira (Portugal) mine. The evaluation of properties conferred by the presence of the MWP filler within asphalt mixtures is based on a physical and mechanical laboratory characterization. For this purpose, tests have been performed both on bituminous mastics and on HMAs. Results indicate that the use of MWP in total substitution of limestone filler does not negatively affect the performances of HMAs and their bituminous mastics

Light vehicle model for dynamic car simulator

Driving simulators have been becoming little by little a suitable tool oriented to improve the knowledge about the domain of driving research. The investigations that can be conducted with this type of tool concern the driver's behaviour, the design/control of vehicles, testing assistance systems for driving and the roadway infrastructure's impact. The benefits of simulation studies are many: lack of any real risk to users, reproducible situations, time savings and reduced testing costs. In addition, their flexibility allows to test situations that do not exist in reality or at least they rarely and randomly exist. The topic of the present work concerns the development of a brand new dynamic model for an existing car simulator owned by LEPSIS laboratory (Laboratoire d'Expliotation, Perception, Simulateurs et Silulations – Laboratory for Road Operations, Perception, Simulators and Simulations) belonging to COSYS (COmposants et SYStems), which is a department of IFSTTAR institute (Institut Français des Sciences et Technologies des Transports, de l'Aménagement et des Réseaux – French Institute of Science and Technology for Transport, Spatial Planning, Development and Networks) site. Once uses and advantages of driving simulators are listed and described, imperfections and limitations of the existing driving vehicle model belonging to the two Degrees of Freedom (DoF) driving simulator of the laboratory are highlighted. Subsequently, structure of the brand new vehicle model, designed by means of Matlab Simulink software, are illustrated through the theoretical framework. Since the vehicle model must refer to a real one, an instrumented Peugeot 406 has been chosen because all its technical features are provided and inserted both on the present model and Prosper/Callas 4.9 by OKTAL software to create a highly sophisticated and accurate virtual version of the commercial car. The validation of this new vehicle model is performed, where the results returned by several different driving scenarios are compared with the ones provided by Prosper software. All the scenarios are simulated with both existing and new vehicle model uploaded in the driving simulator, and the outputs are subsequently compared with the ones returned by Prosper in order to demonstrate the improvements done. Finally, being the number of outputs provided by the new model definitively higher with respect to previous one, additional validations concerning the further results are accomplished

Bike Lane Design: the Context Sensitive Approach

In these days of increasing congestion on roads, bicycles continue to provide a valuable contribution to mobility in Europe. Their relatively small size and low cost enable them to blend efficiently into in the traffic flow while needing less space compared to other vehicles. However, cyclists form one of the most vulnerable groups of road users. So the design of safe infrastructures for all travellers categories, included the cyclists, becomes a primary requirement. To obtain these results, a Context Sensitive Design approach is a very useful tool. In this way, in fact, it is possible to examine a project or existing road, reporting its crash potential and safety performances and detecting its deficiencies, taking into consideration communities and lands which it passes through. In this paper the authors, starting from results collected on a bike lane placed in Rimini, provide useful results for designers, construction and maintenance contractors, in order to obtain safe bike lanes

Parental origin and somatic mosaicism of PHOX2B mutations in Congenital Central Hypoventilation Syndrome.

Heterozygous polyalanine repeat expansions of PHOX2B have been associated with Congenital Central Hypoventilation Syndrome, a rare neurocristopathy characterized by absence of adequate control of respiration during sleep. Here we report a PHOX2B mutational screening in 63 CCHS patients, 58 of whom presenting with poly-A expansions or frameshift, missense and nonsense mutations. To assess a somatic or germline occurrence of poly-A length variations, the relative amounts of mutant and wild type alleles have been quantified in 20 selected CCHS patients presenting with an expansion, and in their parents. Somatic mosaicism was shown in four parents, while no mosaic was found among CCHS patients. Moreover, while co-segregation analysis of the PHOX2B poly-A expansions with selected marker alleles in the same 20 CCHS trios has not demonstrated any parent-of-origin effect of the mutations, it has provided further clues to clarify the molecular mechanism underlying the expansion occurrence. Finally, the segregation of PHOX2B poly-A anomalous tracts within family members has allowed us to exclude tendency of polymorphic variations towards expansion. This strengthens the notion that expanded polyalanine tracts, identified as frequent disease-causing mutations also in other human diseases, are mitotically and meiotically stable

Pedal towards Safety: The Development and Evaluation of a Risk Index for Cyclists †

Cyclists are at a higher risk of being involved in accidents. To this end, a safer environment for cyclists should be pursued so that they can feel safe while riding their bicycles. Focusing on safety risks that cyclists may face is the main key to preserving safe mobility, reducing accidents, and improving their level of safety during their travel. Identifying and assessing risk factors, as well as informing cyclists about them may lead to an efficient and integrated transportation system. Therefore, the purpose of this research is to introduce a risk index that can be adapted to different road areas in order to measure the degree of how risky these areas are for biking. Cyclists’ behavior and demographics were integrated into the risk index calculation. The methodology followed to obtain the risk index composed of four phases: risk factor identification, risk factor weighting, risk index formulation, and risk index validation. Nineteen risk factors are categorized into four major groups: facility features, infrastructure features, cyclist behavior, and weather and traffic conditions