Regulatory Definition Research Articles

Does a Modern European State Need a Law on Legal Acts? What Shall be the Law on Legal Acts in Ukraine?

The purpose of this study is to determine whether a modern European state needs to adopt a law on legal acts as a document that primarily sets out the statutory rules for law-making, which is necessary in order to adapt Ukrainian legislation to the European legal standards.For analytical purposes, we have determined that the European legal framework encompasses special laws on legal acts as well as laws establishing the rules for law-making methods. Research has been done on doctrinal approaches to the legal method issues. In addition, we have made a brief analysis of the European Union legal framework concerning the law-making rules and studied the respective law-making legislation of Ukraine.It has been concluded that the adoption of a special law on legal acts is not a priority task in the field of legal regulation for modern European states, although it is highly desirable in order to develop, amid academic pluralism, approaches to understanding legal methods and the need to compile a list of law-making tools for the purposes of regulatory definition and standardisation of types, forms and rules for evaluating adopted legislation (ex-post evaluation). To make law-making activities efficient in the states that used to be part of the socialist legal system in the past, legal formalisation is required, especially in post-Soviet states, such as Ukraine.

ADMINISTATIVE DISCRETION IN PUBLIC ADMINISTRATION AND ITS CONNECTION WITH LEGAL DEONTOLOGY: THEORETICAL AND LEGAL ASPECT

SummaryIn the process of implementing the functions and objectives of the state to ensure therealization of human rights and freedoms Officials of the public administration authoritiesbased on the concept of building competent administrative legislation оften face the needto make management decisions, based on their administrative discretion. Effectiveness andfeasibility of adopted and implemented in such conditions managerial decisions directlydepends on the professional level of the public administrator. The level of professionalismdepends not only on the level of knowledge and skills of the public administrator, but alsodepends a considerable extent from its desire and desire to properly blame its professionalvocation. Legal deontology contributes to the regulatory definition of the optimal crime ofmoral and ethical requirements compliance with which testifies to the readiness of the publicadministration authorities system to implement the functions and objectives of the state asappropriate. The article analyzes the concept of public administration and is concluded aboutits identity of the Public Administration category. Both administrative and legal categoriesare manifested as the process of developing, making and implement management decisions.Administrative legislation is constructed in such a way that its procedural part based onopportunities based on and within the Constitution and Laws of Ukraine, it is based on publicadministration based on administrative discretion. In public administration, the result of theimplementation of the administrative discretion is the formation of an appropriate managementstyle, as the result of the use and variation association of permissible forms and managementmethods. The public administrator is a representative of the state in a relationship with aperson. The level of rights and freedoms proclaimed by law depends on his managementdecisions. Given the need to appeal when making decisions to administrative discretion, thedeontological component of the professional characteristics of the public administrator seemsto be significant.

APhA, others file federal lawsuit against HHS to close DIR loophole

APhA, others file federal lawsuit against HHS to close DIR loophole

О нормативном закреплении управления конкурентоспособностью российских университетов в компетенциях их руководителей

The article analyzes the Russian educational and labor legislation, as well as qualification guides and professional standards, in order to determine the regulatory and legal definition of the competence of the heads of Russian universities in managing the competitiveness of educational organizations. The author relies on official sources describing and qualifying the rector’s professional activities in university management in order to identify the requirements for professional managerial competencies that make up the core of the professional leadership of an educational organization, which directly ensure the competitiveness of the university. The author quotes the main legislative provisions establishing the professional status of the rector of a university – the head of a Russian university. As a result of the analysis of legal norms and norms of qualification reference books and professional standards, the author comes to the conclusion that the strategically important competences of higher and secondary leaders of educational organizations to ensure the competitiveness of higher education organizations are currently not represented in the Russian Federation either in qualification reference books or in professional standards. Neither in the state educational standards, nor in the regulatory legal acts of labor and educational legislation. The article concludes with the author’s suggestions and recommendations on the normative reflection in the competences of the heads of Russian universities of the competence in managing the competitiveness of an educational organization.

Regulatory exemptions illustrate the humanitarian-development nexus in highly developed cities

In recent years, forcible displacement has increased around the globe, with significant numbers of people seeking shelter in urban areas. However, increased densification has added pressure to housing in these urban host communities, creating a situation where temporary accommodation is not always readily available. The integration of humanitarian response and pre-existing sustainable development activities is necessary to avoid disruptions to the provision of infrastructure services. This humanitarian-development nexus (HD-nexus) has proven to be difficult to operationalize. Using the experience of Sweden in 2015, this study looks at the provision of temporary accommodation for asylum-seekers within the existing regulatory framework as a place to explore the HD-nexus. Results show that humanitarian actors justify circumventing government institutions to achieve short-term response while development activities operate within these same institutions. Regulatory exemptions are one pathway by which we can observe this fundamental difference between the two approaches. Interviews with 19 individuals from government agencies, nonprofit organizations, and private companies were qualitatively analyzed to relate legitimacy with humanitarian response and development logics in the context of providing temporary accommodation. Results show that although formal regulatory definitions of temporary for temporary accommodations exist, this is not always adopted by stakeholders, leading to regulatory exemptions and non-compliance. Findings support decision-makers in improving response time and coordination for future events, and development goals of sustainable urban development.

Les hydratants et lubrifiants vaginaux – Quel statut pour ce type de produits ?

Vaginal lubricants and moisturizers are products of similar composition used as appropriate to alleviate pathological dryness or facilitate sexual intercourse. The status of this type of product is not clear to some companies who confuse cosmetics and medical devices. With regard to the regulatory definition of cosmetics, it appears that this type of product can in no way be marketed under this status.

Bioequivalence of a Generic Nateglinide Formulation in Healthy Chinese Volunteers under Fasting and Fed Conditions: A Randomized, Open-Label, Double-Cycle, Double-Crossover Study

Introduction: Nateglinide or N-(trans-4-isopropylcyclohexyl-1-carbonyl)-D-phenylalanine is a drug with a rapid hypoglycemic effect that is mainly used in the treatment of type 2 diabetes. Very few studies have assessed bioequivalence based on feeding status. This study aimed to assess the pharmacokinetic bioequivalence and safety of nateglinide-containing tablets (0.12 g) in healthy Chinese volunteers under fasting and fed conditions. Methods: The studies were performed in 2017–2018 in the Phase I Clinical Trial Ward of the Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, China. Eligible Chinese volunteers received a single 0.12-g dose of the test or reference formulation, followed by a 7-day washout period and administration of the alternate formulation. Blood samples were collected at various time intervals, and plasma nateglinide concentrations were analyzed by liquid chromatography-tandem mass spectrometry. Then, the adverse events, laboratory test results, vital signs, and physical exam findings were compared between the 2 groups. Results: The ratios of the geometric means of C_max, AUC_0-t, and AUC_0-inf of the tested to reference preparations under fasting conditions were 105.03% (90% confidence interval [CI]: 99.53–110.83%), 104.02% (90% CI: 101.37–106.74%), and 104.04% (90% CI: 101.38–106.77%), respectively. The same ratios under fed conditions were 96.55% (90% CI: 85.80–108.65%), 103.08% (90% CI: 100.07–106.18%), and 103.07% (90% CI: 100.21–106.01%), respectively. The 90% CI values for C_max, AUC_0-t, and AUC_0-inf fell within the accepted range of bioequivalence (80.00–125.0%). Common adverse events included hypoglycemia, heart rate increase, palpitation, sweating, dizziness, and diarrhea. Conclusions: The test formulation (0.12 g) met the CFDA’s regulatory definition for bioequivalence to the reference formulation. Both formulations were well tolerated by healthy Chinese subjects. Trial Registration: This trial has been registered in the Chinese Clinical trial registry (ChiCTR2000030694), March 10, 2020.

Heart Images on Food Labels: A Health Claim or Not?

Health claims on food labels are used by food manufacturers to inform consumers about the health effects of a product, and such claims can have notable effects on consumer preferences. According to regulatory definitions, health claims can be either worded or presented as images, but it is not clear under which conditions an image on a food label should be considered a health claim. This question has important practical implications, as the use of health claims is strictly regulated. The objective of this study was to determine how commonly images of the heart are used on food labels, and to investigate consumers’ perceptions of products labelled with heart images, using different degrees of health relationships. Both a food supply study (N = 10,573 foods) and experiments with consumers (N = 1000) were performed in Slovenia. The use of heart imagery on food products was very common (9%). The consumer study was conducted using a web panel. Structure of the study population was comparable with Slovenian adult population (18–65 years), according to gender and age. The questionnaire was split into conjoint analysis with constructed elements, a choice-based task with real-life elements and a consumers’ association task. The experiments showed that a heart image as part of the brand name itself—without an additional (worded) health claim—did not cause most consumers to relate it to health. However, consumers tended to strongly relate an image of the heart as part of a brand with health benefits, where the image was accompanied by a worded health claim or if the heart image was designed specifically to imply health benefits. We can conclude that the use of heart images was very common on food products, but references to health were less common. Without a health-related context, heart images could not be considered as a health claim.

Drawing Lines in the Sand? Paths Forward for Triggering Regulation of Gene-Edited Crops

Abstract Researchers are making use of new gene-editing techniques in medicine, bioenergy, industrial biotechnology, and beyond, and the field of crop breeding is no exception. These techniques, which differ from genetic modification techniques, spell difficult questions for regulatory oversight: will current rules-of-play apply, or do new techniques necessitate fundamental shifts in regulations? Thus far, little explicit attention has focused on the fundamental yet elusive questions of which technical specifics currently trigger regulation of gene-edited crops, and where different jurisdictions ‘draw’ this line. Here, we trace these regulatory lines across key jurisdictions. We argue that extant regulatory definitions are crumbling in the face of emerging technologies and assert that this breakdown poses a threat to responsible governance. Drawing upon insights from responsible research and innovation, we propose a shift away from technically based regulatory approaches and toward more risk-targeted oversight based on broader societal and ecological implications.

About Possibility to Use Industrial Coal-Rank Classification to Reveal Coal Layers Hazardous Characteristics

The research is concerned with all the fossil coal metamorphism series based on their rank classification. Currently, based on the genetic characters of metamorphic coal conversions, no proved regulatory definition of the coal layer hazardous characteristics is available. For mining forecasts, the regulatory framework uses a limited number of the classificatory parameters with properties, which have not been determined for the whole multiplicity of coals metamorphic transformation. Special features of each coal rank shall be specified using their proxy parameters. It proves that they specify different aspects of the metamorphic coal conversions, as well as other classificatory parameters. For proved forecasting the coal layer hazardous characteristics, it is necessary to use some combinations of the classificatory parameters. It is testified that any alterations of coal properties due to their inner structure conversions may be characterized by maximum and minimum values of different parameters for the same coal rank. The limit for possible alteration of the K rank coals volatile mass yield has been established in lower than normal level. It is noted that coals with the same consumer performance may in some cases be characterized by different values of the classificatory parameters, and in other cases—the coals with different values of the classificatory parameters may have the same processing behavior. It is proposed, when establishing any hazardous properties of the coal layers in addition to the industrial classificatory parameters, one should use alterations of the organic part elemental composition, mineral impurities and moisture in the whole range of metamorphism series.

Regulatory landscape of nanotechnology and nanoplastics from a global perspective

Nanotechnology and more particularly nanotechnology-based products and materials have provided a huge potential for novel solutions to many of the current challenges society is facing. However, nanotechnology is also an area of product innovation that is sometimes developing faster than regulatory frameworks. This is due to the high complexity of some nanomaterials, the lack of a globally harmonised regulatory definition and the different scopes of regulation at a global level. Research organisations and regulatory bodies have spent many efforts in the last two decades to cope with these challenges. Although there has been a significant advancement related to analytical approaches for labelling purposes as well as to the development of suitable test guidelines for nanomaterials and their safety assessment, there is a still a need for greater global collaboration and consensus in the regulatory field. Furthermore, with growing societal concerns on plastic litter and tiny debris produced by degradation of littered plastic objects, the impact of micro- and nanoplastics on humans and the environment is an emerging issue. Despite increasing research and initial regulatory discussions on micro- and nanoplastics, there are still knowledge gaps and thus an urgent need for action. As nanoplastics can be classified as a specific type of incidental nanomaterials, current and future scientific investigations should take into account the existing profound knowledge on nanotechnology/nanomaterials when discussing issues around nanoplastics.This review was conceived at the 2019 Global Summit on Regulatory Sciences that took place in Stresa, Italy, on 24–26 September 2019 (GSRS 2019) and which was co-organised by the Global Coalition for Regulatory Science Research (GCRSR) and the European Commission's (EC) Joint Research Centre (JRC). The GCRSR consists of regulatory bodies from various countries around the globe including EU bodies. The 2019 Global Summit provided an excellent platform to exchange the latest information on activities carried out by regulatory bodies with a focus on the application of nanotechnology in the agriculture/food sector, on nanoplastics and on nanomedicines, including taking stock and promoting further collaboration. Recently, the topic of micro- and nanoplastics has become a new focus of the GCRSR. Besides discussing the challenges and needs, some future directions on how new tools and methodologies can improve the regulatory science were elaborated by summarising a significant portion of discussions during the summit. It has been revealed that there are still some uncertainties and knowledge gaps with regard to physicochemical properties, environmental behaviour and toxicological effects, especially as testing described in the dossiers is often done early in the product development process, and the material in the final product may behave differently. The harmonisation of methodologies for quantification and risk assessment of nanomaterials and micro/nanoplastics, the documentation of regulatory science studies and the need for sharing databases were highlighted as important aspects to look at.

Запобігання героїзації військових злочинців та легалізації нацизму: практичні аспекти

The content of the legal norms enshrining the concepts of Nazism, Holocaust is determined in the research via the use of hermeneutic approach and formal and legal method. Broad and narrow approaches to interpreting these concepts in scientific doctrine have been identified. Their relationship with each other and with the concepts of crimes against humanity and international crimes has been clarified. The countries where Holocaust denial is a criminal offense have been identified. It has been established that jurisdiction of these cases has is not governed in the national legislation of Ukraine. It is concluded that there is no regulatory definition of the concept of the Holocaust at either international or national level. It is proposed to consider the concept of Holocaust as a form of genocide. In order to prevent corruption-causing factors in the regulatory governance of the issue and discrimination against the rights of any racial group, it is proposed to define the concept of Holocaust via a broad approach. The need for the legislator to take into account the intention of Nazis to completely exterminate not only Jews but also Roma, Poles, to take into account the facts of abuse, inhumane medical experiments on Soviet prisoners of war, murders and slave labor of the Slavs, the intention of assimilating civilians of the USSR with German racial group or relocate them beyond the Urals or exterminate when defining the concept of the Holocaust has been substantiated. It has been established that in violation of Article 1, paragraph 1, subparagraph 20 of the Law of Ukraine “On the Legal Status and Honoring the Memory of Fighters for the Independence of Ukraine in the Twentieth Century” No. 314 dated 09.04.2015 the Cabinet of Ministers of Ukraine did not approve the list of organizations, structures and formations existing during the twentieth century aimed at obtaining, restoring or protecting the independence of Ukraine. It has been established that the legislation does not define specific forms of legal and illegal fighting for independence of Ukraine. There is no regulatory definition of fighters for the independence of Ukraine (specific individuals, organizations, other formations) related to the National Socialist Workers’ Party of Germany and its units (SA, SD, SS, Gestapo). A number of recommendations have been provided. In particular, to open access to information about the persecution and mass extermination of Jews, Roma and Slavs during the Second World War, to approve the list of legal and illegal forms of fighting for independence, fighters for independence in the twentieth century.

Anticoagulant and Antiplatelet Use Not Associated with Improvement in Severe Outcomes in COVID-19 Patients

Introduction:SARS-CoV-2 coronavirus (COVID-19) associated coagulopathy leads to higher morbidity and mortality. It is unclear if anticoagulants or antiplatelets in patients with COVID-19 influences disease severity. We report outcomes of COVID-19 patients prescribed anticoagulants or antiplatelets for preexisting conditions within Kaiser Permanente Northern California (KPNC), a large integrated health system serving 4.4 million members.Methods:This retrospective cohort study included KPNC adult members (≥18 years) with positive COVID-19 testing between February 25,2020, and May 8,2020. Patients were stratified based on electronic medical records indicating a filled prescription or actively taking antiplatelets or anticoagulants within 90 days prior to COVID-19 diagnosis.Primary outcomes included emergency department (ED) visit, inpatient hospitalization, intensive care unit (ICU) stay, venous thromboembolism (VTE), mechanical ventilation, and mortality between date of COVID-19 diagnosis and the first of either 45 days after diagnosis or 6/9/2020. Any severe outcome was defined as any of inpatient hospitalization, mechanical ventilation, or mortality. Logistic regression was used to calculate odds ratios and 95% confidence intervals (CI) for the association of anticoagulants or antiplatelets with primary outcomes, adjusting for sociodemographic and clinical characteristics. Models were adjusted for week of diagnosis given changing testing and treatment guidelines over time.The Research Determination Committee for KPNC has determined the project does not meet the regulatory definition of research involving human subjects per 45 CFR 46.102(d).Results:Of 2,972 patients with confirmed positive COVID-19, 167(6%) were on antiplatelets, 69(2%) were on anticoagulants, and 7(<1%) on both. Most patients on anticoagulants or antiplatelets were older (77% aged >60 years), non-white (53%), overweight or obese (69%), and had >3 comorbidities (62%).After adjusting for sociodemographic and clinical characteristics, chronic anticoagulants or antiplatelets use was not associated with a lower risk of any primary outcome, including VTE, ED visit, ICU stay or severe outcome (OR 1.03, CI 0.74-1.45). Older patients had an increased risk of all outcomes except VTE, with the highest risk of severe outcomes in those > 80 years compared to 18-29 years (OR 13.62, CI 7.69-24.11). Male patients and Asian or Hispanic patients (compared to white patients) also had increased risk of severe outcomes. A higher mortality risk was noted in patients with underlying obesity (OR 2.28, CI 1.31-3.95) and hypertension (OR 2.03, CI 1.30-3.19), but not with diabetes (OR 1.43, CI 0.89-2.28). (Table 1)Conclusions:This analysis using a socio-demographically diverse cohort of COVID-19 positive patients demonstrated that patients on chronic anticoagulants or antiplatelets did not have lower risk for inpatient hospitalization, invasive ventilator, or death. There was a significantly higher risk of severe outcomes in those with older age, Asian or Hispanic ethnicity, male gender, obesity, hypertension and diabetes.Infection with COVID-19 can lead to a severe systemic inflammatory response, vascular endothelial dysfunction and hemostatic derangements, predisposing to microvascular and macrovascular thrombi and significant morbidity. Efforts to mitigate the disease severity have generated discussions regarding empiric use of anticoagulants and antiplatelets in COVID-19 patients. We did not find a difference in the risk of hospitalizations, mechanical ventilation or death for patients on chronic anticoagulants or antiplatelets. Our findings argue against the empiric use of these agents at COVID-19 diagnosis until prospective studies powered to evaluate thrombosis risk and clinical outcomes with value to patients and health care systems are completed.The major strength of this study included the availability of all outcomes data for inpatients and outpatients with COVID19. Limitations include possible missed data from undiagnosed COVID-19 patients due to evolving COVID-19 testing and variance in inpatient treatments which may influence outcomes. Despite this, our findings do not suggest a clinical benefit of chronic anticoagulants or antiplatelets in mitigating disease severity in COVID-19 patientsDisclosuresNo relevant conflicts of interest to declare.

What Is Regenerative Agriculture? A Review of Scholar and Practitioner Definitions Based on Processes and Outcomes

Regenerative agriculture is an alternative means of producing food that, its advocates claim, may have lower – or even net positive – environmental and/or social impacts. Regenerative agriculture has recently received significant attention from producers, retailers, researchers, and consumers, as well as politicians and the mainstream media. Despite widespread interest in regenerative agriculture, no legal or regulatory definition of the term ‘regenerative agriculture’ exists nor has a widely accepted definition emerged in common usage. This paper answers the research question: How have different scholars and practitioners defined regenerative agriculture? We reviewed 229 journal articles and 25 practitioner websites to characterize the term ‘regenerative agriculture’. Our review revealed that there were many definitions and descriptions of regenerative agriculture in usage. These were variously based on processes (e.g. use of cover crops, the integration of livestock, and reducing or eliminating tillage), outcomes (e.g. to improve soil health, to sequester carbon, and to increase biodiversity), or combinations of the two. Process-based definitions may imply that advocates or users of such definitions are open-minded about the possible outcomes of these processes. Similarly, outcome-based definitions may imply that users of such definitions are open-minded about the processes that may lead to those outcomes. We discuss the implications of these different forms of definition for policy, including for certification programs and for payments for carbon sequestration programs. More generally, wide variance in the definitions used may lead to uncertainty about what different actors mean when they talk about regenerative agriculture. We suggest that it may be helpful for individual users of the term ‘regenerative agriculture’ to define it comprehensively for their own purpose and context.

For the sake of the Bioeconomy: define what a Synthetic Biology Chassis is!

At the onset of the 4th Industrial Revolution, the role of synthetic biology (SynBio) as a fuel for the bioeconomy requires clarification of the terms typically adopted by this growing scientific-technical field. The concept of the chassis as a defined, reusable biological frame where non-native components can be plugged in and out to create new functionalities lies at the boundary between frontline bioengineering and more traditional recombinant DNA technology. As synthetic biology leaves academic laboratories and starts penetrating industrial and environmental realms regulatory agencies demand clear definitions and descriptions of SynBio constituents, processes and products. In this article, the state of the ongoing discussion on what is a chassis is reviewed, a non-equivocal nomenclature for the jargon used is proposed and objective criteria are recommended for distinguishing SynBio agents from traditional GMOs. The use of genomic barcodes as unique identifiers is strongly advocated. Finally the soil bacterium Pseudomonas putida is shown as an example of the roadmap that one environmental isolate may go through to become a bona fide SynBio chassis.

Preference for directive versus participative leadership: the role of regulatory mode and context quality definition

ABSTRACT Prior work showed that leadership preferences depend not only on followers’ characteristics, but also on contextual features. We investigated how regulatory mode (assessment – a concern with “getting things right” vs. locomotion – a concern with “getting things done” in goal pursuit) and the definition of quality criteria (i.e. whether or not there are predefined standards to evaluate task or work performance) jointly influence followers’ preferences for directive and participative leadership. We measured (Study 1, N = 503) and experimentally induced (Study 2, N = 497) followers’ regulatory mode before presenting them with task instructions that either clearly defined quality criteria or left them undefined. In both studies, participants were led to believe that they would work on a task with a supervising leader and indicated their preferred leader style for the task. Contrary to predictions, results do not suggest that the definition of quality criteria moderates the influence of followers’ regulatory mode on their leadership preferences. Independent of quality criteria conditions, both chronic assessment and locomotion predicted preferences for directive leadership; additionally, chronic locomotion strongly predicted preferences for participative leadership. However, the induced regulatory mode did not influence leadership preferences. Further work is needed to better understand the role of context in self-regulatory dynamics and leadership style preferences.

A Regulatory Roadmap for Financial Innovation

Private sector innovation – whether it is fintech, biotechnology, the platformisation of the economy, or other developments – is the single most profound challenge that regulators confront today. Financial innovations, which are intangible and fast-moving, are especially challenging. Financial regulators are at the operational front line of making sense of the promise and the risks associated with fintech, and helping to ensure it operates for public benefit. Faced with such a changeable and fast-moving problem, how can regulators “future proof” themselves? This chapter outlines a road-map for financial regulators who confront fast-moving and profound change in their sectors. It argues that regulators’ first question in any decision-making context should be, “how is private sector innovation, in this case fintech, undermining my assumptions, changing relationships, denaturing products and markets, and seeping around regulatory definitions and boundaries, right now?” The chapter sets out the four basic questions that regulators should consider. It proposes regulatory responses based on better data collection and analysis, innovation research, network theory, and regulatory design. It considers how to make regulation more adaptable and more resilient, and examines the strategic choices regulators can make in framing fintech innovations.

Commentary - A comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars and Intended Copy Biologics in treating chemotherapy associated febrile neutropenia

Filgrastim, human white cell growth factor, Granulocyte colony-stimulating factor (G-CSF), is a core medicine in the WHO list of Essential Medicines. For this reason, recent reporting of statistically significant safety and efficacy differences between reference and Biosimilar brands of filgrastim by Rastogi and the Indian Pharmacopoeia Commission in Toxicology and Applied Pharmacology in 2020 is of great concern [Shruti Rastogi et al. Towards a comprehensive safety understanding of granulocyte-colony stimulating factor biosimilars in treating chemotherapy associated febrile neutropenia: Trends from decades of data. Toxicology and Applied Pharmacology Volume 395, 15 May 2020, 114,976. https://doi.org/10.1016/j.taap.2020.114976]. This commentary shows that the alarming report is a result of incorrect statistical tests misapplied to inappropriate data sets compounded by a further problem relating to the strict regulatory definition of a Biosimilar Medicine as opposed that of an Intended Copy Biologic. In contrast, the body of evidence from more than seven and a half thousand participants in Confirmatory Clinical Studies and Post Approval Clinical Studies as well as the Periodic Safety Update Reports confirms that European approved filgrastim Biosimilars show no meaningful difference in quality, safety or efficacy compared to the reference brand.

Definitions of Water Quality: A Survey of Lake-Users of Water Quality-Compromised Lakes

Understanding and defining water quality is an important precursor for influencing pro-environmental behavior and accurately assessing potential outcomes of human–lake interactions. This study surveyed 82 lake-users in Nebraska regarding their definitions of water quality and the importance of various water quality features to determine if lake-users’ definitions align with complex and multi-faceted governmental and scientific definitions. Survey sites included two recreational reservoirs (e.g., boating and fishing), Holmes Lake (urban watershed) and Branched Oak Lake (agricultural watershed). The biological and chemical parameters are similar between the lakes and both lakes were listed as “impaired” on the Section 303(d) (United States Environmental Protection Agency, Washington, DC, USA) list of impaired waters of the US at the time of the surveys. The results of our survey suggest that the overwhelming majority of lake-users’ self-generated definitions of water quality did not include more than one feature of water quality found in the relevant policy and regulatory definitions and they focused primarily on water clarity. Further, when provided a list of specific water quality features, the participants rated all provided features of water quality as highly important. This suggests that the failure to include those features in a self-generated definition is not the consequence of perceiving that feature as low importance.

When Does Stand-Alone Software Qualify as a Medical Device in the European Union?-The Cjeu's Decision in Snitem and What it Implies for the Next Generation of Medical Devices.

This contribution analyses the first decision by the Court of Justice of the European Union (CJEU) on the qualification and regulation of stand-alone software as medical devices. Referring to the facts of the case and the applicable European Union (EU) regulatory framework, the Court specifically found that prescription support software may constitute a medical device. This would even be the case where the software does not act directly in or on the human body. Yet, according to the CJEU, it is necessary that the intended purpose falls within one or more of the 'medical purpose' categories of the regulatory definition of 'medical device'. The case has important implications, not only for specific legal debates, but it also signifies a paradigm shift with a rapidly increasing digitalisation of the health and life sciences. This highlights the demand for continuous debates over the necessary evolution of the regulatory framework applying to the interface of medical artificial intelligence (AI) and Big Data.