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This study addresses FinTech implementation challenges in the banking industry in Palestine. This was accomplished by adopting qualitative research methods. Semi-structured interviews were conducted with interviewees from the Palestinian Monetary Authority, banks, and FinTech companies. Thematic analysis was conducted using NVivo 12 software to identify themes in the interview scripts. Research outcomes suggest that FinTech development in Palestine encounters a range of multifaceted challenges, which can be categorised using the TOE (technological, organisational, environmental) framework. On the technological front, issues such as underdeveloped IT and telecommunications infrastructure, restricted mobile frequencies due to Israeli occupation, limited IT expertise, cyber risks, low digital literacy, and minimal FinTech awareness hinder progress. Organizationally, resistance to change, inadequate agility, limited digital skills, and slow Sharia compliance updates in Islamic banking impede innovation. Environmentally, the absence of a dedicated FinTech framework, unclear regulatory guidance, limited market size, and strict AML/CFT regulations create uncertainties for non-bank entities and restrict investment opportunities. Addressing these interconnected barriers requires coordinated efforts across legal, financial, and technological sectors to foster FinTech integration and growth in Palestine. [ABSTRACT FROM AUTHOR]

The European Artificial Intelligence Act (AI Act) has profound implications for technological innovation in the medical and health care sector, transcending the boundaries of existing legal frameworks such as the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR). This paper examines basic regulatory choices of the AI Act relevant for the field of digital health innovations by contextualizing its main goals, key obligations, and addressed actors. In light of these considerations, we present a scoping literature review that identifies potential regulatory challenges for stakeholders engaged in research, innovation and healthcare. Building on this, we point to concepts and methodologies to overcome such challenges in a way fostering innovation while realizing key constitutional and societal interests at the same time. [ABSTRACT FROM AUTHOR]

Small Modular Reactors (SMRs) offer transformative potential for maritime propulsion by providing significant benefits such as reduced emissions, enhanced fuel efficiency, and greater operational autonomy. However, their integration into the maritime sector presents complex regulatory challenges due to the convergence of nuclear and maritime laws. A unified, harmonized regulatory framework is essential to ensure safety, radioactive waste management, and accident prevention. While initiatives led by the International Atomic Energy Agency (IAEA) and International Maritime Organization (IMO) are progressing, key gaps remain, particularly regarding maritime-specific risk assessments, emergency response protocols, and cross-border regulatory harmonization. Enhanced collaboration between regulatory bodies, pilot projects, and transparent engagement with stakeholders will be critical to refining safety protocols and accelerating regulatory alignment. Public acceptance remains a vital factor, requiring rigorous environmental impact assessments (EIAs) and transparent communication to build trust and align SMR-powered vessels with global sustainability objectives. While challenges persist, they also present opportunities for innovation and international cooperation. By addressing these regulatory and public acceptance challenges through coordinated efforts and policies, SMR propulsion can become a cornerstone of a more sustainable, efficient, and technologically advanced maritime sector. Successful deployment will position SMRs as a key component of the global energy transition, driving progress toward low-carbon shipping and a greener maritime industry. [ABSTRACT FROM AUTHOR]

The field of organ transplantation is experiencing a transformative shift with the rise of Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic cell therapies, and tissue-engineered products. These therapies offer new, potentially curative treatments for longstanding medical challenges, impacting numerous patients. However, their adoption is hindered by complex regulatory frameworks, high production costs, and inconsistent access across Europe. The ESOT ATMP Task Force's position paper analyzes these challenges from research to clinical application, advocating for a coordinated strategy to position Europe as a leader in ATMP development. It proposes specific actions such as streamlining regulatory pathways to accelerate approvals, boosting funding for ATMP research, and creating specialized facilities for development and implementation. The paper also highlights the critical roles of patient engagement and real-world evidence in optimizing clinical and regulatory practices. [ABSTRACT FROM AUTHOR]

Cancer remains a leading cause of death globally. Cancer patients often seek alternative therapies in addition to, or instead of, conventional treatments like chemotherapy, radiation, and surgery. The progress in medical advancements and early detection provides more treatment options; however, the development of cancer drugs requires a significant amount of time, demands substantial investments, and results in an overall low percent of regulatory approval. The complex relationship between patent protection and pharmaceutical innovation complicates cancer drug development and contributes to high mortality rates. Adjusting patent criteria for alternative cancer therapeutics could stimulate innovation, enhance treatment options, and ultimately improve outcomes for cancer patients. This article explores the potential of alternative cancer therapeutics, chemopreventive agents, natural products, off-patent drugs, generic unpatentable chemicals, and repurposed drugs in cancer treatment, emphasizing the mechanisms and therapeutic potential of these unconventional compounds as combinatorial cancer therapies. The biological pathways, therapeutic effects, and potential to enhance existing therapies are reviewed, demonstrating their cost-effective and accessible options as adjuvant cancer therapies. [ABSTRACT FROM AUTHOR]

This paper examines the pivotal role of social entrepreneurs in combating urban poverty across diverse global contexts. Urban poverty presents a multifaceted challenge, exacerbated by rapid urbanization, economic inequality, and inadequate access to essential services. Social entrepreneurs emerge as key players, leveraging innovative solutions to address these systemic issues. By integrating social objectives with entrepreneurial strategies, they create sustainable business models that empower marginalized communities and foster economic resilience. The study explores various case studies that highlight successful social enterprises worldwide, illustrating how these initiatives tackle specific urban poverty challenges such as unemployment, lack of education, and inadequate healthcare. Furthermore, the paper discusses the critical factors that contribute to the effectiveness of social entrepreneurship, including community engagement, collaboration with local governments, and the ability to scale solutions. Additionally, the paper highlights the importance of supportive ecosystems that facilitate social entrepreneurship, including access to funding, mentorship, and policy frameworks. It also addresses the challenges faced by social entrepreneurs, such as navigating regulatory environments and sustaining their impact in the long term. This paper emphasizes the transformative potential of social entrepreneurs in fostering inclusive urban development. By aligning economic growth with social progress, they contribute significantly to alleviating urban poverty and promoting sustainable communities. This review underscores the need for greater recognition and support for social entrepreneurship as a viable approach to addressing the pressing issue of urban poverty on a global scale. [ABSTRACT FROM AUTHOR]

Blockchain technology has emerged as a transformative innovation in the financial sector, offering enhanced security, transparency, and operational efficiency. This research paper reviews the various use cases of blockchain technology in finance, including cryptocurrencies, cross-border payments, smart contracts, supply chain finance, central bank digital currencies, and regulatory compliance. Utilizing a qualitative research design, data was gathered from industry reports and peer-reviewed academic papers, and analyzed using content analysis facilitated by NVivo software. The key findings reveal that blockchain significantly improves transaction efficiency and reduces costs. However, major challenges such as regulatory uncertainty, scalability issues, data privacy concerns, and integration with legacy systems hinder widespread adoption. The study underscores the need for clear regulatory frameworks, technological advancements, and strategic collaboration among stakeholders. The broader implications suggest that addressing these challenges is crucial for harnessing the full potential of blockchain technology to revolutionize financial services. [ABSTRACT FROM AUTHOR]

With an eye on the Indian economic scene, this research article investigates the legal obstacles of implementing block chain technology in companies. The paper uses quantitative analysis to evaluate how block chain innovation and startup expansion are affected by legal environments. Through an analysis of the Indian startup scene, the study seeks to shed light on the legal obstacles preventing block chain acceptance and present suggestions for a friendly legislative climate. Complementing the Sustainable Development Goals (SDGs) of the United Nations, the study also emphasises block chain's potential in advancing openness, security, and efficiency. This thorough study aims to guide stakeholders, businesses, and legislators on using block chain for inclusive and environmentally friendly development. By understanding the legal barriers in the Indian startup ecosystem, stakeholders can work towards creating a conducive environment for block chain technology to thrive. With its ability to enhance transparency and streamline processes, block chain has the potential to drive progress towards achieving the SDGs. By leveraging the insights from this study, businesses and policymakers can harness the power of block chain to promote sustainable and inclusive development. This collaboration can lead to innovative solutions that address social and environmental challenges while promoting economic growth. Through strategic partnerships and policy reforms, block chain technology can be harnessed to create a more sustainable future for all. [ABSTRACT FROM AUTHOR]

The traditional labour structures and economic models have been drastically altered as a direct result of the rise of the gig economy. On the other hand, it frequently encounters significant legal barriers, which necessitates the application of advanced crisis communication strategies. This study uses qualitative discourse analysis to investigate a select group of gig economy services such as Uber, Lyft, and DoorDash, in order to analyse public comments, news releases, and social media postings made by these companies. It highlights three key themes by applying grounded theory coding approaches. These themes are compliance and legal adherence, public welfare and safety, along with transparency and openness. The aforementioned facets are effectively included within a central category that is referred to as "Strategic Discourse Management," which displays a purposeful approach for managing public opinion as well as regulatory engagements. From this study, the three major themes which emerged from crisis communication used by the companies are deflection, normalisation and public engagement. This research makes an important contribution to the current body of literature on crisis communication within the contexts of the platform economy and gig economy while providing deep insight for players operating in India. [ABSTRACT FROM AUTHOR]

This manuscript explores the use of nanostructured chitosan for intranasal drug delivery, targeting improved therapeutic outcomes in neurodegenerative diseases, psychiatric care, pain management, vaccination, and diabetes treatment. Chitosan nanoparticles are shown to enhance brain delivery, improve bioavailability, and minimize systemic side effects by facilitating drug transport across the blood–brain barrier. Despite substantial advancements in targeted delivery and vaccine efficacy, challenges remain in scalability, regulatory approval, and transitioning from preclinical studies to clinical applications. The future of chitosan-based nanomedicines hinges on advancing clinical trials, fostering interdisciplinary collaboration, and innovating in nanoparticle design to overcome these hurdles and realize their therapeutic potential. [ABSTRACT FROM AUTHOR]

The field of organ transplantation is experiencing a transformative shift with the rise of Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic cell therapies, and tissue-engineered products. These therapies offer new, potentially curative treatments for longstanding medical challenges, impacting numerous patients. However, their adoption is hindered by complex regulatory frameworks, high production costs, and inconsistent access across Europe. The ESOT ATMP Task Force’s position paper analyzes these challenges from research to clinical application, advocating for a coordinated strategy to position Europe as a leader in ATMP development. It proposes specific actions such as streamlining regulatory pathways to accelerate approvals, boosting funding for ATMP research, and creating specialized facilities for development and implementation. The paper also highlights the critical roles of patient engagement and real-world evidence in optimizing clinical and regulatory practices.

This study addresses FinTech implementation challenges in the banking industry in Palestine. This was accomplished by adopting qualitative research methods. Semi-structured interviews were conducted with interviewees from the Palestinian Monetary Authority, banks, and FinTech companies. Thematic analysis was conducted using NVivo 12 software to identify themes in the interview scripts. Research outcomes suggest that FinTech development in Palestine encounters a range of multifaceted challenges, which can be categorised using the TOE (technological, organisational, environmental) framework. On the technological front, issues such as underdeveloped IT and telecommunications infrastructure, restricted mobile frequencies due to Israeli occupation, limited IT expertise, cyber risks, low digital literacy, and minimal FinTech awareness hinder progress. Organizationally, resistance to change, inadequate agility, limited digital skills, and slow Sharia compliance updates in Islamic banking impede innovation. Environmentally, the absence of a dedicated FinTech framework, unclear regulatory guidance, limited market size, and strict AML/CFT regulations create uncertainties for non-bank entities and restrict investment opportunities. Addressing these interconnected barriers requires coordinated efforts across legal, financial, and technological sectors to foster FinTech integration and growth in Palestine.

Small Modular Reactors (SMRs) offer transformative potential for maritime propulsion by providing significant benefits such as reduced emissions, enhanced fuel efficiency, and greater operational autonomy. However, their integration into the maritime sector presents complex regulatory challenges due to the convergence of nuclear and maritime laws. A unified, harmonized regulatory framework is essential to ensure safety, radioactive waste management, and accident prevention. While initiatives led by the International Atomic Energy Agency (IAEA) and International Maritime Organization (IMO) are progressing, key gaps remain, particularly regarding maritime-specific risk assessments, emergency response protocols, and cross-border regulatory harmonization. Enhanced collaboration between regulatory bodies, pilot projects, and transparent engagement with stakeholders will be critical to refining safety protocols and accelerating regulatory alignment. Public acceptance remains a vital factor, requiring rigorous environmental impact assessments (EIAs) and transparent communication to build trust and align SMR-powered vessels with global sustainability objectives. While challenges persist, they also present opportunities for innovation and international cooperation. By addressing these regulatory and public acceptance challenges through coordinated efforts and policies, SMR propulsion can become a cornerstone of a more sustainable, efficient, and technologically advanced maritime sector. Successful deployment will position SMRs as a key component of the global energy transition, driving progress toward low-carbon shipping and a greener maritime industry.

The purpose of this study is to elucidate the importance of probiotics, regulatory challenges that are faced in developing probiotics as foods and drugs and as well as the Chemistry, Manufacturing and control (CMC)considerations for probiotics. Probiotics are friendly live microorganisms (in most cases, bacteria) that are similar to the beneficial microorganisms found in the human gut and, when consumed, have the potential to improve or maintain the intestinal microbial flora of consumers, thereby benefiting their health. The utilization of probiotics has been in existence for a very long time. Lactobacilli, bifidobacterial, and lactococciare are the examples of probiotics have long been assumed to be safe whereas the most important determinant for probiotics selection is human health safety. Probiotics can be consumed by consumers largely in the form of food and dietary supplements. They are also even available in the form of tablets, capsules and powders and in some other forms as well, yet, their claims of health advantages could put the conventional distinction between food and medicine in jeopardy. The position of the regulatory environment for probiotics within the existing categories has become hazy and quite unclear as a result of the introduction of numerous probiotic products into the global market. [ABSTRACT FROM AUTHOR]

The paper provides a comprehensive examination of heavy metal stress on medicinal plants, focusing on its impact on antioxidant capacity and biosynthetic pathways critical to their therapeutic potential. It explores the complex relationship between heavy metals and the physiological and biochemical responses of medicinal plants, highlighting how metal stress disrupts biosynthetic pathways, altering concentrations of secondary metabolites. This disruption may compromise the overall quality and efficacy of medicinal plants, requiring a holistic understanding of its cumulative impacts. Furthermore, the study discusses the potential of targeted genetic editing to enhance plant resilience against heavy metal stress by manipulating genes associated with antioxidant defenses. This approach represents a promising frontier in safeguarding medicinal plants in metal-contaminated environments. Additionally, the research investigates the role of phytohormone signaling in plant adaptive mechanisms to heavy metal stress, revealing its influence on biochemical and physiological responses, thereby adding complexity to plant adaptation. The study underscores the importance of innovative technologies and global cooperation in protecting medicinal plants' therapeutic potential and highlights the need for mitigation strategies to address heavy metal contamination effectively. [ABSTRACT FROM AUTHOR]

Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.

Cancer remains a leading cause of death globally. Cancer patients often seek alternative therapies in addition to, or instead of, conventional treatments like chemotherapy, radiation, and surgery. The progress in medical advancements and early detection provides more treatment options; however, the development of cancer drugs requires a significant amount of time, demands substantial investments, and results in an overall low percent of regulatory approval. The complex relationship between patent protection and pharmaceutical innovation complicates cancer drug development and contributes to high mortality rates. Adjusting patent criteria for alternative cancer therapeutics could stimulate innovation, enhance treatment options, and ultimately improve outcomes for cancer patients. This article explores the potential of alternative cancer therapeutics, chemopreventive agents, natural products, off-patent drugs, generic unpatentable chemicals, and repurposed drugs in cancer treatment, emphasizing the mechanisms and therapeutic potential of these unconventional compounds as combinatorial cancer therapies. The biological pathways, therapeutic effects, and potential to enhance existing therapies are reviewed, demonstrating their cost-effective and accessible options as adjuvant cancer therapies.

The growing world population, public awareness of animal welfare, environmental impacts and changes in meat consumption leads to the search for novel approaches to food production. Novel foods include products with a new or specifically modified molecular structure, foods made from microorganisms, fungi, algae or insects, as well as from animal cell or tissue cultures. The latter approach is known by various names: "clean meat", "in vitro meat" and "cell‐cultured" or "(cell‐)cultivated meat". Here, cells isolated from agronomically important species are expanded ex vivo to produce cell biomass used in unstructured meat or to grow and differentiate cells on scaffolds to produce structured meat analogues. Despite the fast‐growing field and high financial interest from investors and governments, cultivated meat production still faces challenges ranging from cell source choice, affordable expansion, use of cruelty‐free and food‐grade media, regulatory issues and consumer acceptance. This overview discusses the above challenges and possible solutions and strategies in the production of cultivated meat. The review integrates multifaceted historical, social, and technological insights of the field, and provides both an engaging comprehensive introduction for general interested and a robust perspective for experts. [ABSTRACT FROM AUTHOR]

This manuscript explores the use of nanostructured chitosan for intranasal drug delivery, targeting improved therapeutic outcomes in neurodegenerative diseases, psychiatric care, pain management, vaccination, and diabetes treatment. Chitosan nanoparticles are shown to enhance brain delivery, improve bioavailability, and minimize systemic side effects by facilitating drug transport across the blood–brain barrier. Despite substantial advancements in targeted delivery and vaccine efficacy, challenges remain in scalability, regulatory approval, and transitioning from preclinical studies to clinical applications. The future of chitosan-based nanomedicines hinges on advancing clinical trials, fostering interdisciplinary collaboration, and innovating in nanoparticle design to overcome these hurdles and realize their therapeutic potential.

Abstract The growing world population, public awareness of animal welfare, environmental impacts and changes in meat consumption leads to the search for novel approaches to food production. Novel foods include products with a new or specifically modified molecular structure, foods made from microorganisms, fungi, algae or insects, as well as from animal cell or tissue cultures. The latter approach is known by various names: “clean meat”, “in vitro meat” and “cell‐cultured” or “(cell‐)cultivated meat”. Here, cells isolated from agronomically important species are expanded ex vivo to produce cell biomass used in unstructured meat or to grow and differentiate cells on scaffolds to produce structured meat analogues. Despite the fast‐growing field and high financial interest from investors and governments, cultivated meat production still faces challenges ranging from cell source choice, affordable expansion, use of cruelty‐free and food‐grade media, regulatory issues and consumer acceptance. This overview discusses the above challenges and possible solutions and strategies in the production of cultivated meat. The review integrates multifaceted historical, social, and technological insights of the field, and provides both an engaging comprehensive introduction for general interested and a robust perspective for experts.

Recent coronavirus pandemic and its global socio-economic impact has re-emphasized the need for safe, fast, and efficient delivery of vaccines for humankind. With advent of technological advances, and to improve patient acquiescence, several techniques for fast, effective, and safe delivery of vaccines have been researched and published in the literature in last three decades. These delivery enhancement techniques include but are not limited to electroporation, microneedles (MN), ultrasound, iontophoresis, etc. This review aims at discussing the current research undergoing in vaccine delivery, specifically focusing on microneedles assisted, the historical background of microneedles and their introduction to drug delivery area, and a special focus on formulation challenges and stability in these systems. The review also sheds light on regulatory challenges one must keep in mind for bringing a successful microneedles-based vaccine delivery into market as well as a snapshot of current commercially available microneedles-based products in cosmetic and pharmaceutical industry.

This Review initiates a wide-ranging discussion over 2023 by selecting and exploring core themes to be investigated more deeply in papers submitted to the Vaccines Special Issue on the "Future of Epidemic and Pandemic Vaccines to Serve Global Public Health Needs". To tackle the SARS-CoV-2 pandemic, an acceleration of vaccine development across different technology platforms resulted in the emergency use authorization of multiple vaccines in less than a year. Despite this record speed, many limitations surfaced including unequal access to products and technologies, regulatory hurdles, restrictions on the flow of intellectual property needed to develop and manufacture vaccines, clinical trials challenges, development of vaccines that did not curtail or prevent transmission, unsustainable strategies for dealing with variants, and the distorted allocation of funding to favour dominant companies in affluent countries. Key to future epidemic and pandemic responses will be sustainable, global-public-health-driven vaccine development and manufacturing based on equitable access to platform technologies, decentralised and localised innovation, and multiple developers and manufacturers, especially in low- and middle-income countries (LMICs). There is talk of flexible, modular pandemic preparedness, of technology access pools based on non-exclusive global licensing agreements in exchange for fair compensation, of WHO-supported vaccine technology transfer hubs and spokes, and of the creation of vaccine prototypes ready for phase I/II trials, etc. However, all these concepts face extraordinary challenges shaped by current commercial incentives, the unwillingness of pharmaceutical companies and governments to share intellectual property and know-how, the precariousness of building capacity based solely on COVID-19 vaccines, the focus on large-scale manufacturing capacity rather than small-scale rapid-response innovation to stop outbreaks when and where they occur, and the inability of many resource-limited countries to afford next-generation vaccines for their national vaccine programmes. Once the current high subsidies are gone and interest has waned, sustaining vaccine innovation and manufacturing capability in interpandemic periods will require equitable access to vaccine innovation and manufacturing capabilities in all regions of the world based on many vaccines, not just "pandemic vaccines". Public and philanthropic investments will need to leverage enforceable commitments to share vaccines and critical technology so that countries everywhere can establish and scale up vaccine development and manufacturing capability. This will only happen if we question all prior assumptions and learn the lessons offered by the current pandemic. We invite submissions to the special issue, which we hope will help guide the world towards a global vaccine research, development, and manufacturing ecosystem that better balances and integrates scientific, clinical trial, regulatory, and commercial interests and puts global public health needs first. [ABSTRACT FROM AUTHOR]

Recent coronavirus pandemic and its global socio-economic impact has re-emphasized the need for safe, fast, and efficient delivery of vaccines for humankind. With advent of technological advances, and to improve patient acquiescence, several techniques for fast, effective, and safe delivery of vaccines have been researched and published in the literature in last three decades. These delivery enhancement techniques include but are not limited to electroporation, microneedles (MN), ultrasound, iontophoresis, etc. This review aims at discussing the current research undergoing in vaccine delivery, specifically focusing on MNs assisted, the historical background of MNs and their introduction to drug delivery area, and a special focus on formulation challenges and stability in these systems. The review also sheds light on regulatory challenges one must keep in mind for bringing a successful MNs-based vaccine delivery into market as well as a snapshot of current commercially available MNs-based products in cosmetic and pharmaceutical industry. [ABSTRACT FROM AUTHOR]

A high proportion of depressed patients fail to respond to antidepressant drug treatment. Treatment‐resistant depression (TRD) is a major challenge for the psychopharmacology of mood disorders. Only in the past decade have novel treatments, including deep brain stimulation (DBS) and ketamine, been discovered that provide rapid and sometimes prolonged relief to a high proportion of TRD sufferers. In this review, we consider the current status of TRD from four perspectives: the challenge of developing an appropriate regulatory framework for novel rapidly acting antidepressants; the efficacy of non‐pharmacological somatic therapies; the development of an animal model of TRD and its use to understand the neural basis of antidepressant non‐response; and the potential for rapid antidepressant action from targets (such as 5‐HT1A receptors) beyond the glutamate receptor. LINKED ARTICLES: This article is part of a themed issue on New discoveries and perspectives in mental and pain disorders. To view the other articles in this section visit http://onlinelibrary.wiley.com/doi/10.1111/bph.v179.17/issuetoc [ABSTRACT FROM AUTHOR]

The etiologies of several cardiovascular, inflammatory, neurological, hereditary disorders, cancer, and infectious diseases have implicated changes in the genetic set up or genetic mutations as the root cause. Nucleic acid based therapeutics (NBTs) is a new class of biologics that are known to regulate gene expression at the transcriptional and post-transcriptional level. The NBTs include oligonucleotides, nucleosides, antisense RNA, small interfering RNAs, micro RNA etc. In recent times, this new category of biologics has found enormous potential in the management of cardiovascular, inflammatory, neurological disorders, cancer, infectious diseases and organ transplantation. However, the delivery of NBTs is highly challenging in terms of target specificity (intracellular delivery), mononuclear phagocyte system uptake, stability and biodistribution. Additionally, management of the above mentioned disorders require regular and intrusive therapy making non-invasive routes preferable in comparison to invasive routes like parenteral. The nasal route is garnering focus in delivery of NBTs to the brain in the management of several CNS disorders due to the associated merits such as non-invasiveness, possibility of chronic delivery, improved patient compliance, avoidance of hepatic and gastrointestinal metabolism as well as ability to bypass the BBB. Hence in recent times, this route has been sought by the reserachers as an alternative to parenteral therapy for the delivery of several NBTs. This review shall focus on an array of NBTs delivered through nasal route, their challenges, applications and opportunities. The novel delivery systems for incorporating NBTs; their targeting strategies shall be critically reviewed. The challenges towards regulatory approvals and commercialization shall also be discussed at large. Comparison of learnings derived from the success and barriers in nasal delivery of NBTs will help in identification of futuristic opportunities for their translation from bench to bedside. [ABSTRACT FROM AUTHOR]

The etiologies of several cardiovascular, inflammatory, neurological, hereditary disorders, cancer, and infectious diseases have implicated changes in the genetic set up or genetic mutations as the root cause. Nucleic acid based therapeutics (NBTs) is a new class of biologics that are known to regulate gene expression at the transcriptional and post-transcriptional level. The NBTs include oligonucleotides, nucleosides, antisense RNA, small interfering RNAs, micro RNA etc. In recent times, this new category of biologics has found enormous potential in the management of cardiovascular, inflammatory, neurological disorders, cancer, infectious diseases and organ transplantation. However, the delivery of NBTs is highly challenging in terms of target specificity (intracellular delivery), mononuclear phagocyte system uptake, stability and biodistribution. Additionally, management of the above mentioned disorders require regular and intrusive therapy making non-invasive routes preferable in comparison to invasive routes like parenteral. The nasal route is garnering focus in delivery of NBTs to the brain in the management of several CNS disorders due to the associated merits such as non-invasiveness, possibility of chronic delivery, improved patient compliance, avoidance of hepatic and gastrointestinal metabolism as well as ability to bypass the BBB. Hence in recent times, this route has been sought by the reserachers as an alternative to parenteral therapy for the delivery of several NBTs. This review shall focus on an array of NBTs delivered through nasal route, their challenges, applications and opportunities. The novel delivery systems for incorporating NBTs; their targeting strategies shall be critically reviewed. The challenges towards regulatory approvals and commercialization shall also be discussed at large. Comparison of learnings derived from the success and barriers in nasal delivery of NBTs will help in identification of futuristic opportunities for their translation from bench to bedside.

Background: Solubility properties of drugs intensify a crucial role during the formulation development process. Aqueous solubility is one of the most significant factors concerning drug bioavailability analysis. Cyclodextrins [CDs] are supportive, competent excipients, required an ever-rising way to disguise unwanted pharmaceutical characteristics, exclusively poor aqueous solubility. Main Text: CDs are actively useful in medicinal industries for copious purposes, including improving drug solubility, safety, physicochemical stability, and bioavailability. Different solubility enhancement methods can resolve several approaches to trouble insolubility. Conclusions: Among all, the reported one complexation technique has been incorporated as one of the imperative and the exigent concept, to enhance the solubility of poorly water-soluble drugs. The standard CDs and their explicit derivatives are quite essential in enabling pharmaceutical excipients, which improve the aqueous solubility of poorly soluble drugs, raise the permeability of drugs through the biological membranes, and advances the drug dissolution rate and bioavailability. This review discusses some of the findings and broad applications of CDs and their derivatives in various drug delivery areas. This review also addresses the aspects regarding the new CD-based therapeutics, possible future uses and issues, and regulatory perspective in the modern scenario.

The integration of fog computing into healthcare promises significant advancements in real-time data analytics and patient care by decentralizing data processing closer to the source. This shift, however, introduces complex regulatory, privacy, and security challenges that are not adequately addressed by existing frameworks designed for centralized systems. The distributed nature of fog computing complicates the uniform application of security measures and compliance with diverse international regulations, raising concerns about data privacy, security vulnerabilities, and legal accountability. This review explores these challenges in depth, discussing the implications of fog computing's decentralized architecture for data privacy, the difficulties in achieving consistent security across dispersed nodes, and the complexities of ensuring compliance in multi-jurisdictional environments. It also examines specific regulatory frameworks, including Health Insurance Portability and Accountability (HIPAA) in the United States, General Data Protection Regulation (GDPR) in the European Union, and emerging laws in Asia and Brazil, highlighting the gaps and the need for regulatory evolution to better accommodate the nuances of fog computing. The review advocates for a proactive regulatory approach, emphasizing the development of specific guidelines, international collaboration, and public-private partnerships to enhance compliance and support innovation. By embedding privacy and security by design and leveraging advanced technologies, healthcare providers can navigate the regulatory landscape effectively, ensuring that fog computing realizes its full potential as a transformative healthcare technology without compromising patient trust or data integrity., Competing Interests: Conflicts of interest: In compliance with the ICMJE uniform disclosure form, all authors declare the following: Payment/services info: All authors have declared that no financial support was received from any organization for the submitted work. Financial relationships: All authors have declared that they have no financial relationships at present or within the previous three years with any organizations that might have an interest in the submitted work. Other relationships: All authors have declared that there are no other relationships or activities that could appear to have influenced the submitted work., (Copyright © 2024, Jeyaraman et al.)

Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products-a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (© 2024 Gupta, Tiwari, Yadav, Soni and Joshi.)

The article provides a description of the Autonomous ship, studies existing relevant projects, and examines the related Operational, Regulatory, and Quality assurance challenges raised due to the development and actual deployment of such vessels in the near future. After reviewing the main operational procedures, existing regulations, and quality assurance standards, a number of possible solutions and approaches to overcome the identified challenges are indicated. Some of the conclusions may be used not only in the Autonomous ships but also in traditionally manned vessels.

The recent proliferation of mobile financial services in developing countries has increased access to financial services among underserved rural and low-income populations. Mobile credit is one emerging mobile financial service that allows consumers to quickly apply for and receive loans over mobile devices. Mobile credit services have achieved early success in Kenya and Tanzania, two mature markets for mobile financial services. While these new services have the potential to further promote financial inclusion, they also raise novel regulatory issues and do not fit neatly into pre-existing regulatory categories. This is due to the nature of mobile credit and the variety of entities and regulatory frameworks implicated in the business models found in these two markets. Policymakers and regulators will need to make choices about how to regulate mobile credit with respect to consumer protection, credit reporting and the use of mobile and mobile money services transactional data, a key input for credit evaluation decisions. These choices will need to take into account promotion of financial inclusion and protection of consumers while limiting disincentives for innovation and investment.

Many of the scientific and regulatory challenges that exist in research on the safety, quality and efficacy of dietary supplements are common to all countries as the marketplace for them becomes increasingly global. This article summarizes some of the challenges in supplement science and provides a case study of research at the Office of Dietary Supplements at the National Institutes of Health, USA, along with some resources it has developed that are available to all scientists. It includes examples of some of the regulatory challenges faced and some resources for those who wish to learn more about them. [ABSTRACT FROM AUTHOR]

Personalized Medicine is a novel medical practice that uses an individual's genetic profile to guide decisions made regarding the prevention, diagnosis, and treatment of disease. Knowledge of a patient's genetic profile is crucial to support doctors in selecting the proper therapy and administer it using the correct dose or regimen. Personalized Medicine is a great opportunity to turn the "one size fits all" approach to diagnostics, therapy, and prevention, into an individualized approach. In this paper we analyze the most recent achievements and regulatory challenges in Personalized Medicine and the role that research infrastructures can play in advancing its development.

Hospital information systems (HIS) are a core component of the healthcare system. These systems have been in use for decades worldwide and for many years now in the Middle East. Many hospitals in Saudi Arabia started to adopt HIS, but still faced with many challenges. On top of these come the organizational, financial and regulatory challenges. The main objective of this study is to identify, analyze and evaluate these three categories of challenges perceived by healthcare professionals in order to provide decision makers with suggestions and recommendations on proper actions. The study used survey methods to collect data from healthcare professionals at two main Saudi hospitals known for their experience implementing HIS, and then analyzed the results to describe and evaluate challenges. The study validated 10 organizational, 6 financial and 6 regulatory challenges and explored participants' experiences regarding each. The study sorted challenges importance from the most to the least; financial challenges came first, then organizational challenges while regulatory challenges came last. Government hospital users had more concerns than private, regarding all of the three categories of challenges. Some demographic variables, such as age, gender, experience and profession, had significant influence on the perception of healthcare professionals towards different challenges. The study recommends providing or outsourcing the required experience of hospital management to choose, to implement and to evaluate HIS performance. Redesigning workflows to match HIS is a viable option for successful implementation. Clear time frame for implementation is very essential. Allocating proper and enough investments, especially at the initial phase of implementation, is important. Feasibility studies on benefits versus costs of implementing and using HIS are crucial for decision makers. Much work still to be done on developing regulations, policies and procedures on both hospital and national levels to govern adoption, implementation and utilization of HIS. [ABSTRACT FROM AUTHOR]

This article aims to address challenges of translating emerging scientific technologies into legal terms and incorporate them into the existing North American regulatory regimes. A lack of full scientific knowledge about nanomedicine technologies results in the lack of development in legal discourse to describe products and to clearly set legal standards on their safety and efficacy. The increasing complexity and hybrid nature of technologies negatively impact the functionality of 'law in action' leading to a legal uncertainty and ultimately to a public distrust. Nanomedicine is an illustrative example of how law lags behind increasingly fast-paced scientific technologies making it difficult to find a balance between innovation and safety. This article argues that the boundary crossing nature of nanomedicine through different domains of science triggers a methodological and epistemological debate within science and law, suggesting that a critical revision is required in our traditional methods to learn, create, and categorize knowledge from breakthrough scientific advances. The highly disruptive nature of nanomedicine places stress on traditional conceptual frameworks, classifications of knowledge, and existing regulations. The legal challenge to identify definitions or to classify nanoapplications brings to light a conceptual vacuum surrounding nanomedicine. Moving away from confusing policies and obsolete classificatory models, this article suggests to undertake changes that are only the first steps of a more in-depth 'epistemological transformation' that addresses knowledge as the process of not only gathering data, but also, as the process of elaborating new conceptual bases to better fulfill the legal language and facilitate the legal task of finding definitions and formulating criteria more adherent with scientific advances. This should compel regulators to explore new paradigms and develop new methodologies to evaluate data on nanomedicine applications in order to provide sustainable bases for a responsible development of nanomedicine. [ABSTRACT FROM AUTHOR]