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Global support and standardization of regulation for biosimilars approval owes much of its legacy to the World Health Organization (WHO), since the first guidance by the organization on the matter was released in 2009. Since then, and with over a decade of research, the 2022 revision provides opportunities for time and financial savings to pharmaceutical manufacturers aiming to prove similarity of a potential biosimilar product to some reference product, particularly by clarifying that the use of a non-local reference product as a comparator in certain studies is permissible. This declaration has important implications, particularly in the emerging biological markets of the Middle East and North Africa region, where WHO guidelines have been integral to the regulatory framework of over a dozen countries for more than a decade. This article aims to review the impact of this revision on these countries and relevant policies on non-local comparator usage. Since 2022, this revision has been adopted only in Egypt. Many North African countries are yet to adopt a first draft of the formalized guidance. This analysis revealed that, although many of these countries reference the WHO guidelines, hesitation remains in terms of sourcing comparator products outside the US or European countries. This likely translates to slow regional development and cooperation of functioning, sustainable biosimilars markets. Future studies will be necessary to evaluate the continued development of guidance within these countries and changes in comparator sourcing norms as more time is allowed for their policies to mature and adapt to new standards.

This project convened a series of meetings and workshops to prioritize listening to multi-sector stakeholders from local government, advocacy, and industry in US cities where autonomous vehicles are operating. The objective was to listen and learn from all stakeholders, raise issues surrounding accessibility and equity, and to solicit responses. Key findings from the workshops include a consensus across the three sectors on the need for good channels of multi-stakeholder communication, and voices across all sectors agreed on the importance of disability access and serving diverse populations. Many parties, representing voices from all sectors, recognized that federal regulatory activities appear to be moving too slowly. Preventing any roadway incidents is a priority for many stakeholders, and some suggest a playbook for handling day-to-day roadway issues and common standards for first-responder interactions. Disability access is a high priority across all sectors, and there many see nearer term to accommodations for blind, hearing-impaired riders, but the timeline for providing service to people with non-folding wheelchairs is less clear. There is also ongoing debate surrounding the limits of regulatory purview, the role for cities, and how to actualize equitable expansion into rural areas. There is more work to do to advance a multi-sector dialogue around the role for local governments and community-based organizations in shepherding a safe, equitable and sustainable expansion of autonomous vehicles.

BackgroundElectronic health records (EHRs) are a cost-effective approach to provide the necessary foundations for clinical trial research. The ability to use EHRs in real-world clinical settings allows for pragmatic approaches to intervention studies with the emerging adult HIV population within these settings; however, the regulatory components related to the use of EHR data in multisite clinical trials poses unique challenges that researchers may find themselves unprepared to address, which may result in delays in study implementation and adversely impact study timelines, and risk noncompliance with established guidance.ObjectiveAs part of the larger Adolescent Trials Network (ATN) for HIV/AIDS Interventions Protocol 162b (ATN 162b) study that evaluated clinical-level outcomes of an intervention including HIV treatment and pre-exposure prophylaxis services to improve retention within the emerging adult HIV population, the objective of this study is to highlight the regulatory process and challenges in the implementation of a multisite pragmatic trial using EHRs to assist future researchers conducting similar studies in navigating the often time-consuming regulatory process and ensure compliance with adherence to study timelines and compliance with institutional and sponsor guidelines.MethodsEight sites were engaged in research activities, with 4 sites selected from participant recruitment venues as part of the ATN, who participated in the intervention and data extraction activities, and an additional 4 sites were engaged in data management and analysis. The ATN 162b protocol team worked with site personnel to establish the necessary regulatory infrastructure to collect EHR data to evaluate retention in care and viral suppression, as well as para-data on the intervention component to assess the feasibility and acceptability of the mobile health intervention. Methods to develop this infrastructure included site-specific training activities and the development of both institutional reliance and data use agreements.ResultsDue to variations in site-specific activities, and the associated regulatory implications, the study team used a phased approach with the data extraction sites as phase 1 and intervention sites as phase 2. This phased approach was intended to address the unique regulatory needs of all participating sites to ensure that all sites were properly onboarded and all regulatory components were in place. Across all sites, the regulatory process spanned 6 months for the 4 data extraction and intervention sites, and up to 10 months for the data management and analysis sites.ConclusionsThe process for engaging in multisite clinical trial studies using EHR data is a multistep, collaborative effort that requires proper advanced planning from the proposal stage to adequately implement the necessary training and infrastructure. Planning, training, and understanding the various regulatory aspects, including the necessity of data use agreements, reliance agreements, external institutional review board review, and engagement with clinical sites, are foremost considerations to ensure successful implementation and adherence to pragmatic trial timelines and outcomes.

The vast majority of all global species have circadian rhythm cycles that allow them to adapt to natural environments. These regular rhythms are regulated by core clock genes and recent studies have also implicated roles for microRNAs in this regulation. Oviposition is an important circadian behavior in the reproductive cycle of insect vectors of diseases, and little is known about the rhythm or its regulation in mosquitoes. Aedes albopictus is a diurnal mosquito that transmits arboviruses and is the major cause of outbreaks of dengue fever in China. We analyzed the oviposition rhythm patterns of A. albopictus under different light/dark conditions and show that the mosquitoes have an oviposition peak between zeitgeber time 9 (ZT 9) and ZT 12. Furthermore, the antagomir-mediated knockdown of expression of the microRNA miR-2940-1 affected the oviposition rhythm of A. albopictus. These data support the conclusion that miR-2940-1 is involved in the regulation of oviposition rhythm in A. albopictus and provide a foundation for using oviposition rhythms as a new target for vector mosquito control.

Advanced air mobility (AAM) is a broad concept that enables consumers access to air mobility, goods delivery, and emergency services through an integrated and connected multimodal transportation network. AAM can provide short-range urban, suburban, and rural flights of about 50-miles and mid-range regional flights up to a several hundred miles. State law delegates responsibility for oversight in aviation primarily to the California Department of Transportation (Caltrans). This white paper presents an overview of the state of the market, such as the aircraft under development and forecast market growth and discusses factors that could facilitate the development of AAM or pose risks to its deployment or to the public, including the safety and the regulatory environment, airspace and air traffic management, security, environmental impacts, weather, infrastructure and multimodal integration, workforce and economic development, social equity, and community engagement and social acceptance. It concludes by recommending actions that Caltrans and other state agencies can take to facilitate the development of AAM.

The study assessed the manifestation of a regulated locomotion pattern while clearing the first two hurdles during running. In addition, the effect of a hurdles' learning design, using specific activities and manipulated task constraints, on regulation strategies and kinematic reorganization was examined. Pre- and posttests were conducted. Twenty-four young athletes were randomly assigned into an experimental and a control group, and performed 18 training sessions, consisting of a hurdle-based intervention for experimental participants and a more generalized athletics training for control participants. Different footfall variability curves were recorded, suggesting that young athletes regulated locomotion pattern to clear the hurdles according to their needs. Task-specific training contributed to lower values of variability for the entire approach run and to functional movement reorganization, affording learners to take-off further from the hurdle with a higher horizontal velocity, leading to a more flat hurdle clearance stride and to a significant hurdle running performance improvement. [ABSTRACT FROM AUTHOR]

Comprehensive Summary: DNA 5‐formylcytosine (5fC) is a prominent epigenetic modification within biological systems. Recent investigations have shed light on its pivotal role in governing cell fate, gene expression, and disease pathways. However, our comprehension of the precise control of the 5fC site structure to influence its functionality remains limited. In this study, we have successfully achieved precise control over 5fC activity by harnessing the interaction between streptavidin and biotin. This research underscores the potential application of interactions between biomacromolecules and small molecules in advancing the field of DNA epigenetic functional regulation. [ABSTRACT FROM AUTHOR]

Copyright of Shipin Kexue/ Food Science is the property of Food Science Editorial Department and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Comprehensive Summary: DNA 5‐formylcytosine (5fC) is a prominent epigenetic modification within biological systems. Recent investigations have shed light on its pivotal role in governing cell fate, gene expression, and disease pathways. However, our comprehension of the precise control of the 5fC site structure to influence its functionality remains limited. In this study, we have successfully achieved precise control over 5fC activity by harnessing the interaction between streptavidin and biotin. This research underscores the potential application of interactions between biomacromolecules and small molecules in advancing the field of DNA epigenetic functional regulation. [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) offers potential strategies to address existing challenges facing health systems in the United States (U.S.). However, the development of the AI market for health care over the past decade also poses risks to public value in the short- and long-term. In this commentary, we describe the nature of large technology companies’ interface with health care in the U.S., outlining their roles in the context of their leadership in the platform economy. First, we describe the risks associated with the potential dominance of Big Tech companies in healthcare and outline the short-term context for regulating AI as it relates to Big Tech’s role in healthcare. We then explore the possibilities of regulatory approaches that might encourage the anticipation of risks and enforcement of responsible technology practices while retaining the goal of enhancing public value as a primary aim of healthcare policy. [ABSTRACT FROM AUTHOR]

Electron spin polarization (ESP) refers to the alignment of electron spins in a specified direction, with burgeoning research underscoring its pivotal role in enhancing rechargeable batteries. This review delves into the theoretical underpinnings of ESP and its intricate connection to the performance of rechargeable batteries, elucidating its potential to augment charge/discharge efficiency, elevate energy density, and refine overall battery functionality. The review further encompasses an overview of experimental methodologies employed to probe ESP in rechargeable battery systems, spotlighting seminal discoveries from contemporary studies and evaluating the hurdles and prospects linked to its practical applications. The profound advantages of ESP for rechargeable batteries are underscored, suggesting that harnessing this phenomenon can empower researchers and engineers to develop batteries with superior energy storage capacities, swifter charging rates, and extended cycle lifespans. Such advancements can expedite the adoption of electric vehicles and the seamless integration of renewable energy sources into power grids, among other high‐energy‐demand applications. In conclusion, this review offers invaluable perspectives on rechargeable batteries through the lens of ESP, with the insights presented here expected to catalyze further research and innovation in the energy storage sector, thereby advancing the development of sustainable and efficient rechargeable battery technologies. [ABSTRACT FROM AUTHOR]

Background: Radiopharmaceuticals have been considered a special group of medicines in Europe since 1989. The use of radiopharmaceuticals that have marketing authorization should always be the first option in clinical use, however due to their special properties the availability of approved radiopharmaceuticals is limited. For this reason, they can be produced on a small scale outside the marketing authorization process. Main body: The in-house radiopharmaceutical preparations represent an important source of these special medicines for routine nuclear medicine practice. However, a lack of harmonization in Member States' regulations leads to extreme differences in the use and availability of radiopharmaceuticals across Europe. The aim of this work is to provide an overview of the different national regulatory frameworks in which Directive 2001/83/UE is adopted on the preparation of radiopharmaceuticals outside the marketing authorization track in Europe. Nine different national regulations have been studied to describe how unlicensed radiopharmaceuticals are prepared. Special attention is paid to reflect the minimum standards that these preparations should meet as well as the educational requirements to be a radiopharmacist in charge of them. Conclusion: The rapid development of new radiopharmaceuticals used in radiometabolic therapy requires a common regulation that allows balance between the use and preparation of licensed and unlicensed radiopharmaceuticals. The absence of a harmonized regulation for the radiopharmaceutical small-scale preparation and the implementation of Good Manufacture Practices, leads to extreme differences in the use, quality assurance and availability of radiopharmaceuticals in Europe. [ABSTRACT FROM AUTHOR]

Artificial intelligence (AI) demonstrates various opportunities and risks. Our study explores the trade-off of AI technology, including existential risks. We develop a theory and a Bayesian simulation model in order to explore what is at stake. The study reveals four tangible outcomes: (i) regulating existential risks has a boundary solution of either prohibiting the technology or allowing a laissez-faire regulation. (ii) the degree of 'normal' risks follows a trade-off and is dependent on AI-intensity. (iii) we estimate the probability of 'normal' risks to be between 0.002% to 0.006% over a century. (iv) regulating AI requires a balanced and international approach due to the dynamic risks and its global nature. [ABSTRACT FROM AUTHOR]

New arrangements of power are emerging in response to the turbulence generated by the quest to improve life and render it productive. This paper specifies such arrangements by developing the concept of metabolic politics: an apparatus that shifts from discipline to power regulating material, bodily, and environmental transformations. The dominant function of metabolic politics is to render the transformative capacities of living bodies and the circulatory dynamics of materials into object‐targets of governance. Through a comparative analysis of regulating pollution from industrial poultry units in Britain and India, the paper identifies logics of a metabolic politics and distinguishes these from the biopolitics of populations. Metabolic politics entails interventions targeting a milieu rather than deviant populations; its actions are directed at transformative capacities of bodies in addition to improving their productivity; its modes of governance operates via regulation and not just discipline; and its techniques of operation proceed through modulation instead of enclosure. Metabolic politics is a transversal form of power. It is situated and historically contingent, rather than uniform and universal. As a response to crises generated by the industrialisation and cheapening of life, metabolic politics furnishes vital insights into the administration and governance of the contemporary living and material world. [ABSTRACT FROM AUTHOR]

How can multiple organizational, social, and political actors effectively address the contemporary challenges of digital political campaigning? We proceed by reviewing the increased theoretical and empirical importance of digital political campaigning. We discuss the new research advances in the field and acknowledge the necessity for interdisciplinary research given the rapidly evolving techniques and the imminent positive and negative risks of digital campaigning. We present a multi-level actor approach for dealing with the risks of digital political campaigning. We outline the contribution of this issue and identify relevant gaps for future research. [ABSTRACT FROM AUTHOR]

Since the Cambridge Analytica scandal, governments are increasingly concerned about the way in which citizens' personal data are collected, processed and used during election campaigns To develop the appropriate tools for monitoring and controlling this new mode of "data-driven campaigning" (DDC) regulators require a clear understanding of the practices involved. This paper provides a first step toward that goal by proposing a new organizational and process-centred operational definition of DDC from which we derive a set of empirical indicators. The indicators are applied to the policy environment of a leading government in this domain – the European Union (EU) – to generate a descriptive "heat map" of current regulatory activity toward DDC. Based on the results of this exercise, we argue that regulation is likely to intensify on existing practices and extend to cover current "cold spots". Drawing on models of internet governance, we argue that this expansion is likely to occur in one of two ways. A "kaleidoscopic" approach, in which current legislation extends to absorb DDC practices and a more "designed" approach that involves more active intervention by elites, and ultimately the generation of a new regulatory regime. [ABSTRACT FROM AUTHOR]

Crowdfunding and micro-donations for funding political campaigns have been extensively studied, especially in the US. However, digital participatory financing in Europe, with a different regulatory context and relevant public funding, has been investigated less. This article analyses the effects of an innovative and digital-native electoral campaign financing tool: the microcredit. Microcredits consist of small "civil loans" that a political party requests from sympathizers to finance the party's electoral campaign. Based on the case study of the Spanish party Podemos – the first one to implement it – for the period of 2015–2021, we use official data and party documents to explore the consequences of microcredit. We argue, first, that microcredits (and party financing) should be considered another way to differentiate challenger parties from traditional ones. Second, there is a link between the number and amount of microcredits and the political context, not limited to good electoral expectations but also to the polarized political context. Third, microcredits change the structure of campaign funding. Finally, we point out a regulation problem that may deter other parties from adopting this mechanism and present different legal problems (monitoring, data protection, or potential corruption), showing the regulatory issues for adapting to the digitalization of politics. [ABSTRACT FROM AUTHOR]

The European Medicines Agency adopted their Geriatric Medicines Strategy more than a decade ago. The strategy aims at elucidating the evidence basis for marketing authorization of new medicines which will be used in the older population, and at ensuring the appropriate communication of findings to the patient and healthcare provider. During the past decade new tools and data sources have emerged to support the strategy goals, and their use should be considered. Possible concrete actions are presented to improve the design of clinical trials, the data collection both pre‐ and post‐approval, the assessment of the findings, and the communication to assist informed prescription and safe medicine taking. Implementation and prioritization of these actions should be done from the perspective of addressing the needs of patients while maximizing efficient use of resources, with the aim of integrating geriatric aspects into routine medicines development and assessment. [ABSTRACT FROM AUTHOR]

A variety of theories have been proposed to explain why states pass legislation to regulate professional groups, and why, more recently, they have acted to curtail professional privileges. While these theories have drawn attention to the importance of power dynamics and public protection, among other factors, the role of political interests has been downplayed. This article builds on ecological theory to argue that, with some modifications, the theory illuminates the centrality of state‐profession relations and politics to regulatory change. The theory is applied to a case study of regulatory change in British Columbia, Canada impacting resources‐sector professions, with particular attention to the controversies and political considerations that shaped reform. The case study suggests that when the political and professions ecologies are overlapping and symbiotic, as they were in BC, a challenge in the political ecology can implicate professions, prompting a solution that brings change within both ecologies. [ABSTRACT FROM AUTHOR]

Oxygen sensing is of paramount importance for maintaining cellular and systemic homeostasis. In response to diminished oxygen levels, the hypoxia-inducible factors (HIFs) orchestrate various biological processes. These pivotal transcription factors have been identified as key regulators of several biological events. Notably, extensive research from our group and others has demonstrated that HIF1α exerts an inverse regulatory effect on steroidogenesis, leading to the suppression of crucial steroidogenic enzyme expression and a subsequent decrease in steroid levels. These steroid hormones occupy pivotal roles in governing a myriad of physiological processes. Substantial or prolonged fluctuations in steroid levels carry detrimental consequences across multiple organ systems and underlie various pathological conditions, including metabolic and immune disorders. MicroRNAs serve as potent mediators of multifaceted gene regulatory mechanisms, acting as influential epigenetic regulators that modulate a broad spectrum of gene expressions. Concomitantly, phosphodiesterases (PDEs) play a crucial role in governing signal transduction. PDEs meticulously manage intracellular levels of both cAMP and cGMP, along with their respective signaling pathways and downstream targets. Intriguingly, an intricate interplay seems to exist between hypoxia signaling, microRNAs, and PDEs in the regulation of steroidogenesis. This review highlights recent advances in our understanding of the role of microRNAs during hypoxia-driven processes, including steroidogenesis, as well as the possibilities that exist in the application of HIF prolyl hydroxylase (PHD) inhibitors for the modulation of steroidogenesis. [ABSTRACT FROM AUTHOR]

Summary: Vascular bundles transport water and photosynthate to all organs, and increased bundle number contributes to crop lodging resistance. However, the regulation of vascular bundle formation is poorly understood in the Arabidopsis stem.We report a novel semi‐dominant mutant with high vascular activity, hva‐d, showing increased vascular bundle number and enhanced cambium proliferation in the stem. The activation of a C2H2 zinc finger transcription factor, AT5G27880/HVA, is responsible for the hva‐d phenotype. Genetic, biochemical, and fluorescent microscopic analyses were used to dissect the functions of HVA.HVA functions as a repressor and interacts with TOPLESS via the conserved Ethylene‐responsive element binding factor‐associated Amphiphilic Repression motif. In contrast to the HVA activation line, knockout of HVA function with a CRISPR‐Cas9 approach or expression of HVA fused with an activation domain VP16 (HVA‐VP16) resulted in fewer vascular bundles. Further, HVA directly regulates the expression of the auxin transport efflux facilitator PIN1, as a result affecting auxin accumulation. Genetics analysis demonstrated that PIN1 is epistatic to HVA in controlling bundle number.This research identifies HVA as a positive regulator of vascular initiation through negatively modulating auxin transport and sheds new light on the mechanism of bundle formation in the stem. [ABSTRACT FROM AUTHOR]

Background: The regulatory role of gut microbiota and gut-derived metabolites through the gut-liver axis in the development of cirrhotic portal hypertension (PH) has received increasing attention. Methods: The review summarized a series of investigations on effects of metabolites derived from microbiota and medicines targeting microbiome including rifaximin, VSL#3, statins, propranolol, FXR agonists as well as drugs derived from bile acids (BAs) on PH progression. Results: Patients with PH exhibit alterations in gut microbial richness and differential overall microbiota community, and several results clearly displayed the correlation of PH with enrichment of Veillonella dispar or depletion of Clostridiales, Peptostreptococcaceae, Alistipes putredinis, Roseburia faecis and Clostridium cluster IV. The gut-derived metabolites including hydrogen sulfide, tryptophan metabolites, butyric acid, secondary BAs and phenylacetic acid (PAA) participate in a range of pathophysiology process of PH through modulating intrahepatic vascular resistance and portal blood flow associated with the formation and progression of PH. Established and emerging drugs targeting on bacterial translocation and intestinal eubiosis are gradually identified as potential strategies for treatments of liver cirrhosis and PH by modulating intestinal inflammation, splanchnic arterial vasodilation and endothelial dysfunction. Conclusions: Future explorations should further characterize the alteration of the fecal microbiome and metabolite profiles in PH and elucidate the regulatory mechanism of the intestinal microbiome, gut-derived metabolites and gut microbiota targeted pharmaceutical treatments involved in PH. [ABSTRACT FROM AUTHOR]

The list of standard abbreviations for JDS is available at adsa.org/jds-abbreviations-24. Nonstandard abbreviations are available in the Notes. The global food animal industry faces a growing concern regarding antimicrobial resistance (AMR), primarily driven by the use of antimicrobials (AM) for the treatment, control, and prevention of diseases. Addressing this challenge requires promoting responsible antimicrobial use (AMU) practices. In 2019, the province of Québec, Canada, took a significant step by implementing a regulation that limits the use of AM of very high importance for human medicine (category I AM as defined by Health Canada) in the food animal industry. However, the implementation of such regulation can significantly influence behavioral shifts among producers, contributing to the wider effort against AMR. Therefore, the objective of this observational study was to describe the perceived changes in dairy producers' knowledge and on-farm practices following the implementation of this regulation, using a cohort design. Data collection involved administering questionnaires to 87 dairy producers from 3 regions of the province of Québec (Estrie, Montérégie, Centre-Du-Québec) before (2017–2018) and after (2020–2021) the implementation of the regulation. The questionnaires explored the descriptive characteristics of farms, the knowledge of producers about the categorization of AM, the on-farm treatment practices, and the perceived effects of the regulation. Statistical analysis included t -tests and McNemar tests to compare the paired data obtained using the 2 questionnaires. The results indicated an increase in the knowledge score (the number of AM correctly categorized by the producers by their importance for human medicine) after the implementation of the regulation, suggesting an improved understanding of the categorization of AM based on their importance for human medicine. Trends in AMU practices for treating clinical mastitis and reproductive diseases suggested that category I AM were less likely to be reported as the primary treatment after the regulation, whereas category II AM were more often reported as primary treatment. Adoption of the selective dry cow therapy method significantly increased, whereas the use of teat sealants remained unchanged. Moreover, producers had divergent perceptions regarding the effect of the regulation on the cure rates and disease frequencies. This disparity emphasizes the need for comprehensive data collection to discern the risks associated with such regulatory shifts. The study acknowledges several limitations, including the potential for recall bias, confirmation bias, and desirability bias. Despite these limitations, this study shows that implementing regulations to encourage responsible AMU drives positive transformations in producers' knowledge and on-farm practices. This underscores the pivotal effect of proactive interventions in combating the escalating threat of AMR within the global food animal industry. [ABSTRACT FROM AUTHOR]

This paper explores how an agent's incentives map into her performance. We let the agent choose how much effort to invest and which project to implement. We show that the relationship between an agent's incentives to perform and her expected performance could be negative and we characterize alternative conditions for a negative relationship. This also holds true when the principal instead of the agent makes the project choice. We thereby show that the you-get-what-you-pay-for principle is not robust and offer a non-behavioral explanation for the failure of incentives. The results have implications for regulation and ownership structures. [ABSTRACT FROM AUTHOR]

This research investigates the extent to which educational law features and is constructed in the Teaching Council's documentation for Initial Teacher Education (ITE) programmes (2017, 2020) and in the Code of Professional Conduct for Teachers (Code) (2016), and analyses teachers' required knowledge of the law across these documents. Document analysis was used to track changes and provide insights. The findings indicate that teachers' knowledge of educational law has a low profile in the criteria used to review and accredit ITE programmes. Despite significant developments in law related to schools and teachers since 2017, including additional statutory requirements for child protection, the 2020 document does not have a commensurate increase in emphasis on law. Contrastingly, the findings indicate a high profile, and a high bar, for teachers' knowledge of the law in the Code. Recommendations include that the Teaching Council analyse graduates' legal knowledge during registration to ensure that they have the requisite skills to adequately perform as a professional; that the emphasis on educational law be increased in the ITE criteria so that it is aligned with the Code, and that programme providers fulfil their duty of care to students by providing them with adequate standalone modules on educational law. [ABSTRACT FROM AUTHOR]

This study explores the implementation of the One Sample Strategy (OSS), a co-regulation program aimed at managing mycotoxin risk in Texas maize. Fumonisin-contaminated cereals and oilseeds that contain greater than 5 mg kg−1 of the toxin (B1, B2, and B3) are a risk for equids and rabbits, and levels greater than 60 mg kg−1 are a risk to ruminants. The OSS, previously successful in managing aflatoxin risk in Texas maize, was evaluated for its effectiveness in handling fumonisin risk in maize, specifically as it relates to ruminants. In 2017, 25 analysts across seven firms qualified to participate in the program. To ensure greater accuracy in testing, working control samples were provided to the participating OSS firms with the requirement that their results fall within +/− 20% of the target concentration. Ninety-four percent of the working controls met this specification. The capability to grind maize to the OSS prescribed particle size was met by 100% of participants. To verify testing accuracy, file samples collected from each OSS firm were analysed by UPLC–MS/MS. The 177 fumonisin verification samples analysed by Office of the Texas State Chemist (OTSC) were correlated (r = 0.93) with co-regulation laboratories. Results were plotted in an operating curve to depict type I and type II errors. Error analysis revealed a type I error rate of 13% and type II error rate of 2% for the 5 mg kg−1 guidance level, and 6% and 8%, respectively, for the 60 mg kg−1 guidance level. For 2017, 994 official reports of analysis for fumonisin in whole maize in the Texas High Plains were issued by the seven laboratories that employed 25 OTSC-credentialed analysts. The OSS co-regulation program, supported by a quality systems approach and government regulations, has proven effective in managing fumonisin risk in Texas maize, enhancing both market confidence and livestock safety. [ABSTRACT FROM AUTHOR]

The presence of gender disparity in de jure rules across the world is relatively well-known. Many studies show that this disparity is detrimental to female labor participation. Our focus is different in that we examine whether firms with females amongst ownership experience elevated time costs and burdens associated with government regulations relative to their male-owned counterparts. In this sense, we are interested in both de facto and de jure differences in governmental regulation. Using firm-level data and two alternative matching methods, our results suggest that firms with at least one female owner report that senior management spends a larger percentage of their time dealing with regulations. We also find that construction permits take approximately 4–7 days longer to obtain for these same firms. Lastly, we find that female-owned firms perceive labor regulations to be a larger obstacle to business operations. In all cases, these effects tend to be largest in countries with the most disparity in de jure rules. However, the gap remains even in the most de jure equal countries. [ABSTRACT FROM AUTHOR]

'Urban citizenship' connotes to statuses and practices centred around the relationship between a locality and (all) individuals present or residing within its territory. This alternative imagination of citizenship (as opposed to formal nation-state citizenship) is based on a presumption of belonging for persons present/resident in the locality (ius domicii) and includes those typically excluded by the nation-state, in a radical vision of equality and non-discrimination. But domestic legal competences of local governments vary significantly across jurisdictions. This article, based on field research in Turkey and Switzerland, explores what role such domestic competences, or the regulation of local governments, plays in facilitating, encouraging, discouraging or obstructing local governments' engagement with radically inclusive urban citizenship practices. First operationalising the concept of 'regulation' and establishing Turkey and Switzerland as low- and high-regulation country contexts respectively, this article identifies four ways in which regulation shapes urban citizenship practices of local governments: (a) by shaping local governments' perception on their own autonomy; (b) by influencing whether local governments engage in legally foreseen or extra-legal practices; (c) by informing whether and how much local governments categorise different groups of rights-holders and; (d) by affecting which scales these urban citizenship practices are exercised in (upwards, downwards, horizontal). [ABSTRACT FROM AUTHOR]

Agricultural improvements that reduce conventional pesticide use and support environmental aims are a priority. Current approaches develop promising alternative products but meet significant challenges in bringing them to market. This article reports findings of an Association of Applied Biologists event at which delegates from relevant industry sectors discussed the establishment of an effective integrated pest management innovation system linking multiple stakeholders. Interrelated recommendations were agreed upon, focused on structured gap analysis, co‐design processes reflecting the complete innovation system, the approval process, application equipment, enhancing grower confidence, integrating knowledge exchange activities, promulgation of public good information and the need for an overarching national action plan and supporting legislation. [ABSTRACT FROM AUTHOR]

This study aims to develop evidence-based policies and infrastructure for diverse Hajj pilgrim needs, aligning with SDGs. Hajj, Islam's fifth pillar, is mandatory for physically, socially, and spiritually capable Muslims, despite ranking the last. Among Indonesians, completing the Hajj holds profound significance. To support the pilgrimage, the government, through the Ministry of Religious Affairs, has established the Integrated Hajj Information System for Saudi Arabia pilgrim coordination. However, the system hasn't fully accommodated people with disabilities (PwDs), a significantly growing number, and primarily aged pilgrims with health issues. Thus, the Indonesian government must endorse tailored provisions, infrastructure, and services respecting PwDs' human rights. [ABSTRACT FROM AUTHOR]

Tobacco use is associated with serious health problems. Global efforts, such as the World Health Organization's Framework for Tobacco Control, have reduced tobacco use, but challenges remain. Initially perceived as aids for smoking cessation, e-cigarettes have gained popularity among young people and non-smokers. Government approaches to regulating e-cigarettes range from treating them like tobacco, requiring a prescription for their use to outright bans. Although touted as a valuable alternative, evidence suggests that increased e-cigarette use carries potential direct and indirect health risks, necessitating urgent regulatory measures on a global scale. Lack of defined and uniform regulations poses substantial public health risks, compounded by marketing targeting vulnerable groups. Immediate interventions, public awareness, and research are essential to effectively control the current e-cigarette epidemic. [ABSTRACT FROM AUTHOR]

This article aims to examine the national mechanism applied in Bulgaria to tackle the high electricity prices in the period 2021-2023 and its impact on state-owned enterprises, which are the main source of the compensation funds. The proposed thesis is that with the collection of the revenues of state-owned companies, they are posted in conditions of restriction in terms of development opportunities, which is why the imposed emergency measures should be reviewed in the future. Although the measures themselves are widely discussed, the mechanisms for providing financial support, the financial magnitude of this support, as well as its effect, are yet to be clarified, and the data collected in the material may be useful for further analyses and evaluations. [ABSTRACT FROM AUTHOR]

Copyright of Zeitschrift für Sozialreform is the property of De Gruyter and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

High-growth firms (HGFs) are important for job creation and productivity growth. We investigate the relationship between product and labour market regulations, as well as the quality of regional governments that implement these regulations, and the development of HGFs across European regions. Using data from Eurostat, the Organisation for Economic Co-operation and Development (OECD), World Economic Forum (WEF), and Gothenburg University, we show that both regulatory stringency and the quality of the regional government relate to the regional shares of HGFs. In particular, we find that the effect of labour and product market regulations is moderated by the quality of regional government. Depending on the quality of regional governments, regulations may have a 'good, bad or ugly' influence on the development of HGFs. Our findings contribute to the debate on the effects of regulations and offer important building blocks to develop tailored policy measures that may influence the development of HGFs in a region. [ABSTRACT FROM AUTHOR]

Literature on the operation of regulatory agencies and their interactions with the executive branch of government is well established. Much less attention has been devoted to the relationship between these agencies and the courts, especially in case of judicial review of regulators' decisions. This paper examines how judicial review of regulatory decisions produces clashes and agreements between regulatory agencies and the courts, and the influence of these relationships on regulatory governance. The research was conducted in Brazil with 21 interviews, consisting of eight officials of six federal regulatory agencies, seven attorneys from five agencies, and six federal judges. Regulatory governance, institutional theory, and regulatory overlap were the main analytical frameworks for this research. Data was subjected to content analysis. The findings showed that judicial review plays an important role in the overlapping scopes between courts and regulatory agencies. The institutional details of regulatory governance are crucial for the regulatory bodies to function. Despite the conflicts, judges seek more coordination with regulators, because of a greater awareness of the specifics of regulatory policies. Attorneys of regulatory bodies perform a key role in the dialogue between regulators and courts, especially by bridging the gap between technical and legal protocols. Regulatory litigation provides powerful economic agents with the opportunity to obtain a successful remittance of fines, thereby diluting the regulators' ability to enforce regulation. Points for practitioners: Judicial review is the only coordinating mechanism between regulatory agencies and the courts and plays a crucial role in defining regulatory policies and in controlling administrative behavior. In the process of judicial review, regulatory bodies confront the uncertainties that mark the blurred boundaries between the roles performed by state actors and authorities in dealing with regulation. By examining the Brazilian case, the research sheds light on regulatory governance and deals with the balance of power between the judiciary and formally independent regulatory bodies. The findings indicate the value of closer dialogue between regulators and courts in a context where regulatory agencies are increasingly called upon to make important technical and social choices on highly sensitive public issues. [ABSTRACT FROM AUTHOR]

This study analyses and explains how the Ultimate Fighting Championship (UFC) acquired and retains monopoly and monopsony power over Mixed Martial Arts (MMA) in a complex political, legal, regulatory, and financial context. A qualitative and interpretive approach to research underpins a thematic analysis of social media and journalistic content alongside a review of a limited academic literature. It is found that the UFC has acquired and retained monopoly and monopsony power in a context of weak regulation, limited competition, ineffective legal and political intervention, and an absence of unionisation. The three key strategies employed by the UFC to sustain power over MMA were found to be 1. control of athlete labour via restrictive contracts; 2. acquisition of competitor promotions, expertise, and commercial contracts; and 3. building reputation and legitimacy via public relations and lobbying activities. The UFC has employed a combination of legitimate, referent, reward, expert, informational, and coercive power to become the dominant organisation in MMA. [ABSTRACT FROM AUTHOR]

Copyright of Environmental & Social Management Journal / Revista de Gestão Social e Ambiental is the property of Environmental & Social Management Journal and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Anthocyanins are a class of natural water-soluble pigments found in plants, which are responsible for the varied colours of vegetative tissues and reproductive organs. The regulation of anthocyanin biosynthesis requires multiple factors, including enzymes, structural or regulatory genes, and transcriptional regulator proteins. While there has been notable advancement in comprehending anthocyanin biosynthesis, encompassing its structures and overarching regulation, there remains a gap in our understanding concerning the intricate interactions among various genes, molecular and biochemical mechanisms, and their feedback responses to anthocyanin regulatory networks. This article aims to provide an overview of the current understanding of the complex regulatory networks involved in the phenylpropanoid pathway, with a specific focus on anthocyanin biosynthesis. [ABSTRACT FROM AUTHOR]

Copyright of Journal of International Business Studies is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)