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BackgroundDrugs and high-risk medical devices are increasingly likely to receive Food and Drug Administration (FDA) approval through expedited pathways, which has implications for informed treatment consent (i.e., consent in clinical practice).ObjectiveTo obtain expert opinion about the clinical and ethical implications of the increasing availability of new drugs and devices approved through expedited development and regulatory review pathways.DesignQualitative study using individual semi-structured videoconference interviews.ParticipantsNational leaders in medicine, ethics, and law (n=12) with expertise in medical product regulation, payor policymaking, bioethics, physician practice, patient advocacy, public health expertise/advocacy, clinical trials, the pharmaceutical and device industry, institutional review board oversight, and real-world evidence.Main MeasuresPrincipal themes in 3 domains: expedited regulatory pathways, physician and patient understanding of and reliance on FDA approval, and informed treatment consent.Key ResultsRespondents pointed out that more common use of expedited pathways translates to increased reliance on surrogate measures, some with uncertain clinical significance. While expedited development and review can have advantages, participants expressed worry that physicians were unaware when medical products were expedited and did not communicate about uncertainties in knowledge about new drug or device approvals effectively with patients. Many participants felt that informed treatment consent discussions about new drugs or devices should include some explanations of expedited pathways and use of surrogate measures.ConclusionsExperts identified advantages of expediting development and of FDA flexibility in applying its standards to new drugs and medical devices, but highlighted concerns that patients may not be adequately informed about the risks of shorter review times or about uncertainties in the evidence that result. There is a need to identify approaches to ensure effective clinical use of drugs and devices when approved through expedited pathways.

Background Health practitioner regulators throughout the world use continuing professional development (CPD) standards to ensure that registrants maintain, improve and broaden their knowledge, expertise and competence. As the CPD standard for most regulated health professions in Australia are currently under review, it is timely that an appraisal of the evidence be undertaken. Methods A systematic review was conducted using major databases (including MEDLINE, EMBASE, PsycInfo, and CINAHL), search engines and grey literature for evidence published between 2015 and April 2022. Publications included in the review were assessed against the relevant CASP checklist for quantitative studies and the McMaster University checklist for qualitative studies. Results The search yielded 87 abstracts of which 37 full-text articles met the inclusion criteria. The evidence showed that mandatory CPD requirements are a strong motivational factor for their completion and improves practitioners’ knowledge and behaviour. CPD that is more interactive is most effective and e-learning is as effective as face-to-face CPD. There is no direct evidence to suggest the optimal quantity of CPD, although there was some evidence that complex or infrequently used skills deteriorate between 4 months to a year after training, depending on the task. Conclusions CPD is most effective when it is interactive, uses a variety of methods and is delivered in a sequence involving multiple exposures over a period of time that is focused on outcomes considered important by practitioners. Although there is no optimal quantity of CPD, there is evidence that complex skills may require more frequent CPD.

Background: Platelet-rich plasma (PRP) is widely used in various medical and surgical specialties for its regenerative properties, including aesthetics (facial rejuvenation, hair restoration, and skin tightening) and orthopedics (treatment of tendinitis and osteoarthritis). However, the inconsistent literature on PRP’s efficacy and safety leads to critical knowledge gaps. This systematic review evaluates quality control measures in PRP preparation and application and explores the regulatory environment governing its clinical use. Methods: Following PRISMA guidelines, a comprehensive search was conducted across multiple databases, including PubMed, EMBASE, and Web of Science, for studies published from January 2020 to April 2024. The review included randomized controlled trials (RCTs) involving human participants undergoing PRP treatment for aesthetic or regenerative purposes. Key parameters such as the PRP preparation methods, platelet concentration, and quality control measures were analyzed. The study protocol was registered with PROSPERO (ID: CRD42024557669). Results: Out of 75 RCTs involving 5726 patients, the review identified significant variability in PRP preparation methods and application techniques, including differences in centrifugation protocols and platelet concentration levels. A new evidence-based scoring system, the William–Eqram Scoring System for PRP Quality Reporting (WESS-PQR), was proposed to address these inconsistencies. Correlation analysis revealed a strong positive correlation (r = 0.79) between proper temperature control during preparation and PRP efficacy. Initial platelet count assessment showed a moderate positive correlation (r = 0.57) with efficacy. Conclusions: Standardized PRP preparation protocols and robust regulatory frameworks are urgently needed to ensure the safety and efficacy of PRP treatments. The proposed WESS-PQR scoring system can serve as a valuable tool for clinicians and researchers, promoting consistency and reliability in PRP applications.

Soil pollution caused by potentially toxic metals has become a worldwide environmental issue. Geogenic processes and anthropogenic activities are two important sources of soil pollution. Soils may inherit toxic metals from parent materials; however, soil pollution mostly results from industrial and agricultural activities. Contamination by metals can be indicated by the changes in chemical, biochemical, and microbial properties of soils and plant responses. The total concentration of toxic metals in soil is still the most widely used indicator for risk assessment although extractable amounts have been reported to be more closely related to plant uptake. Several models have been proposed for assessing soil contamination by toxic metals, but none of them are commonly accepted for application to a wide range of soils. This review paper highlights how toxic metal contamination negatively affects soil and environmental quality, impacts food quality and security, and poses a threat to human health. Further research is needed to not only improve soil contamination diagnosis, modeling, and regulatory standards but also for remediation efficiency.

Lithium-ion batteries (LIBs) are fundamental to modern technology, powering everything from portable electronics to electric vehicles and large-scale energy storage systems. As their use expands across various industries, ensuring the reliability and safety of these batteries becomes paramount. This review explores the multifaceted aspects of LIB reliability, highlighting recent advancements and ongoing challenges. The importance of safety has been underscored by numerous incidents, such as the well-known smartphone battery explosions and more than 10,000 fires a year at facilities throughout Australia, both linked to LIB failures. These events emphasize the need for robust reliability and safety measures to ensure consistent performance and longevity. Factors like battery chemistry, design, manufacturing, and operating conditions can all influence the reliability of LIBs. Despite their widespread use, the mechanisms of failure, failure rates, and consequences of LIB failures are still not well understood, raising significant safety concerns. Current reliability assessment techniques include experimental methods, computational models, and data-driven approaches. Emerging trends, such as advanced characterization techniques and standardized testing protocols, advocate for improved practices to enhance the reliability and safety of LIBs across all applications.

Sanitation is essential for the cost-effective pest management of stored-product insects. The Food, Drug and Cosmetic Act of 1938 led to the Food and Drug Administration (FDA) tightening regulatory standards, and many local surveys, courses and conferences were organized to prepare the industry for these new regulations. Sanitation removes insects and residual food, which may also provide shelter for insects, with heat treatments and insecticide applications. The number of insects removed by cleaning may be reduced as the number of available hiding places increases. Decreased sanitation negatively affects the efficacy of most other pest management practices, with means of 1.3- to 17-fold decreases in efficacy. The majority of studies quantifying the efficacy of sanitation have been performed on the farm storage of grain, but some studies have been conducted for grain elevators, food processing, and the marketing system. Results ranged from no effect of sanitation alone to very effective alone or with other methods. Sanitation can also reduce insect infestation prior to harvest. Some cost–benefit analyses have been conducted for sanitation.

European legal norms have exerted significant influence on international legal orders, in particular in the fields of trade, arbitration, and human rights law. This study investigates the extent of European law's influence on international legal orders by examining principal trends and case studies. This study reveals the worldwide spread of EU-style competition laws, investor-state dispute settlement regimes, and regulatory norms in non-European legal orders. Based on a qualitative approach, the study evaluates the influence of the ECHR on United Nations treaties, regional human rights courts, and national legal orders. Results show that EU competition policy shapes global trade rules, GDPR serves as a model for data protection laws around the world, and European human rights jurisprudence is widely cited in international courts. The study concludes that European legal norms continue to drive international legal harmonization, solidifying the EU's role as a global legal standard-setter.

In recent decades, extra virgin olive oil demand has grown globally. The increasing popularity has led to a highly diversified commercial offer: supermarkets and discounters present a wide variety of brands and price ranges. However, price does not always correlate with quality, and label information can often mislead consumers. Understanding consumer preferences, knowledge, and drivers of perceived quality is crucial for maintaining trust in the extra virgin olive oil sector. This study investigates the alignment between consumers' expectations based on label information and the actual quality of extra virgin olive oils through a commercial and chemical analytical screening. The research objectives included a consumer survey to identify purchasing drivers, consumption habits, and knowledge of quality standards; a commercial survey on the extra virgin olive oil available in different stores, assessing brand, price variability, and transparency of information; and chemical and sensory analyses on selected extra virgin olive oils of different price ranges to evaluate whether the declared quality reflects the actual quality. The results showed significant inconsistencies in quality: although all oils were labeled as extra virgin olive oil, many medium‐ and low‐priced samples presented sensory defects that EU regulations prohibit for extra virgin olive oil. Notably, oils with more detailed and transparent labeling, such as harvest year, cultivar, and extraction method, tended to perform better in chemical and sensory analyses, regardless of price. This suggests that consumers may better assess quality by scrutinizing label information rather than relying solely on price, highlighting the practical importance of comprehensive labeling. This study evaluates whether retail extra virgin olive oils meet quality expectations based on consumer perceptions, label information, and price. Combining consumer surveys with chemical and sensory analyses of extra vergin olive oils, we reveal significant discrepancies between declared and actual quality, particularly in lower‐priced oils. Our findings emphasize the need for improved labeling transparency and consumer education to enhance trust and informed purchasing decisions.

This study analyzes conditional conservatism in regulatory and corporate financial statements of Brazilian electrification cooperatives, using data from ANEEL (2011-2022) from 36 cooperatives. The Ball and Shivakumar (2005) model of conditional conservatism was applied using fixed-effects regressions. The results showed significant differences: the regulatory standard presented a more optimistic perspective, while the corporate standard was more conservative. The quality of accounting information varies according to the accounting standard, impacting the perception of conservatism. This study is useful for regulators and cooperatives, expanding the understanding of the quality of accounting information in electrification cooperatives. Keywords: Electrification Cooperatives; Conditional Conservatism; Economic Regulation; Corporate Standard; Regulatory Standard. Este estudio analiza el conservadurismo condicional en los estados contables regulatorios y societarios de cooperativas de electrificación brasileñas, utilizando datos de ANEEL (2011-2022) de 36 cooperativas. Se aplicó el modelo de conservadurismo condicional de Ball y Shivakumar (2005) mediante regresiones de efectos fijos. Los resultados mostraron diferencias significativas: el estándar regulatorio presentó una perspectiva más optimista, mientras que el estándar societario fue más conservador. La calidad de la información contable varía según el estándar contable, lo que impacta la percepción del conservadurismo. Este estudio es útil para los reguladores y los cooperativistas, ampliando la comprensión de la calidad de la información contable en cooperativas de electrificación.Palabras clave: Cooperativas de Electrificación; Conservadurismo Condicional; Regulación Económica; Estándar Societario; Estándar Regulatorio. Este estudo analisa o conservadorismo condicional em demonstrativos contábeis regulatórios e societários de cooperativas de eletrificação brasileiras, utilizando dados da ANEEL (2011-2022) de 36 cooperativas. O modelo de Ball e Shivakumar (2005) de conservadorismo condicional foi aplicado com regressões por efeitos fixos. Os resultados mostraram diferenças significativas: o padrão regulatório apresentou uma perspectiva mais otimista, enquanto o padrão societário foi mais conservador. A qualidade das informações contábeis varia conforme o padrão contábil, impactando a percepção de conservadorismo. Este estudo é útil para reguladores e cooperados, ampliando a compreensão da qualidade da informação contábil em cooperativas de eletrificação. Palavras-Chave: Cooperativas de Eletrificação; Conservadorismo Condicional; Regulação Econômica; Padrão Societário; Padrão Regulatório.

Medicine regulation is essential for safeguarding the safety, efficacy, and quality of pharmaceutical products available in medicine retail outlets (MROs). It ensures that medicines, whether sourced locally or internationally, comply with stringent quality standards and regulatory protocols to protect public health. Effective regulation enhances trust in pharmaceutical markets by ensuring the availability of safe and effective medications. However, the regulatory framework within healthcare facilities, particularly in MROs where significant drug-related information is exchanged, is often underperforming. This issue is particularly pronounced in low-and middle-income countries like Ethiopia, where MROs play a critical role as the initial point of healthcare contact. This review aims to assess the level of compliance with pharmaceutical regulatory standards in medicine retail outlets (MROs) in Ethiopia and to evaluate the enforcement of these standards in the country's pharmaceutical market. The review utilized online databases such as PubMed, and Web of Science to collect relevant studies and reports. It focused on issues of regulatory compliance in MROs in Ethiopia, identifying gaps in practice, drug quality, and adherence to national guidelines set by the Ethiopian Food and Drug Authority (EFDA). The review revealed significant regulatory compliance issues within Ethiopian MROs, leading to the distribution of poor quality medicines. It was found that drugs obtained from non-compliant outlets failed to meet quality control standards outlined in drug monographs. Many MROs and pharmacy professionals were found to be non-compliant with EFDA guidelines. Additionally, dispensing and storage practices in MROs were not in line with EFDA regulations and required improvements. The review underlines the need for regulatory enforcement in Ethiopia health settings to address issues of non-compliance and the distribution of poor-quality drugs. It suggests that regulatory bodies should enhance inspection measures and provide opportunities for continued professional development for pharmacy staff and regulatory personnel. Collaboration among regulatory authorities, government, professionals, and academic researchers are pivotal to improving compliance and ensuring the availability of safe, effective, and quality medicines within medicine retail outlets and then protecting public health.