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Neoantigen, unique peptides resulting from tumor-specific mutations, represent a promising frontier in oncology for personalized cancer immunotherapy. Their unique features allow for the development of highly specific and effective cancer treatments, which can potentially overcome the limitations of conventional therapies. This paper explores the current prospects and challenges associated with the application of neoantigens in oncology. We examine the latest advances in neoantigen identification, vaccine development, and adoptive T cell therapy. Additionally, we discuss the obstacles related to neoantigen heterogeneity, immunogenicity prediction, and the tumor microenvironment. Through a comprehensive analysis of current research and clinical trials, this paper aims to provide a detailed overview of how neoantigens could revolutionize cancer treatment and the hurdles that must be overcome to realize their full potential., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

Nanoparticles (NPs) pose a significant concern in drinking water due to their potential health risks and environmental impact. This review provides a comprehensive analysis of the current understanding of NP sources and contamination in drinking water, focusing on health concerns, mitigation strategies, regulatory frameworks, and future perspectives. This review highlights the importance of nano-specific pathways, fate processes, health risks & toxicity, and the need for realistic toxicity assessments. Different NPs like titanium dioxide, silver, nanoplastics, nanoscale liquid crystal monomers, copper oxide, and others pose potential health risks through ingestion, inhalation, or dermal exposure, impacting organs and potentially leading to oxidative stress, inflammatory responses, DNA damage, cytotoxicity, disrupt intracellular energetic mechanisms, reactive oxygen species generation, respiratory and immune toxicity, and genotoxicity in humans. Utilizing case studies and literature reviews, we investigate the health risks associated with NPs in freshwater environments, emphasizing their relevance to drinking water quality. Various mitigation and treatment strategies, including filtration systems (e.g., reverse osmosis, and ultra/nano-filtration), adsorption processes, coagulation/flocculation, electrocoagulation, advanced oxidation processes, membrane distillation, and ultraviolet treatment, all of which demonstrate high removal efficiencies for NPs from drinking water. Regulatory frameworks and challenges for the production, applications, and disposal of NPs at both national and international levels are discussed, emphasizing the need for tailored regulations to address NP contamination and standardize safety testing and risk assessment practices. Looking ahead, this review underscores the necessity of advancing detection methods and nanomaterial-based treatment technologies while stressing the pivotal role of public awareness and tailored regulatory guidelines in upholding drinking water quality standards. This review emphasizes the urgency of addressing NP contamination in drinking water and provides insights into potential solutions and future research directions. Lastly, this review worth concluded with future recommendations on advanced analytical techniques and sensitive sensors for NP detection for safeguarding public health and policy implementations., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024 Elsevier B.V. All rights reserved.)

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., 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., (Copyright © 2024 Berishvili, Piemonti, de Koning, Lindstedt, Scholz, Scott, Auxenfans, Johnson, Martin, Gunther, Mey, Potena and Thaunat.)

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 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.)

Chimeric Antigen Receptor-T cell (CAR-T) therapy has evolved as a revolutionary cancer treatment modality, offering remarkable clinical responses by harnessing the power of a patient's immune system to target and eliminate cancer cells. However, the development and commercialization of CAR-T cell therapies are accompanied by complex regulatory requirements and challenges. This therapy falls under the regulatory category of advanced therapy medicinal products. The regulatory framework and approval tools of regenerative medicine, especially CAR-T cell therapies, vary globally. The present work comprehensively analyses the regulatory landscape and challenges in CAR-T cell therapy development in four key regions: the United States, the European Union, Japan, and India. This work explores the unique requirements and considerations for preclinical studies, clinical trial design, manufacturing standards, safety evaluation, and post-marketing surveillance in each jurisdiction. Due to their complex nature, developers and manufacturers face several challenges. In India, despite advancements in treatment protocols and government-sponsorships, there are still several difficulties regarding access to treatment for the increasing number of cancer patients. However, India's first indigenously developed CAR-T cell therapy, NexCAR19, for B-cell lymphoma or leukemia, approved and available at a low cost compared to other available CAR-T therapies, raises great hope in the battle against cancer. Several strategies are proposed to address the identified hurdles from global and Indian perspectives. It discusses the benefits of aligning regulatory requirements across regions, eventually facilitating international development and enabling access to this transformative therapy., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Copyright © 2024. Published by Elsevier B.V.)

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.)

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.

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.

RNA-based medicines have potential to treat a large variety of diseases, and research in the field is very dynamic. Proactively, The European Medicines Agency (EMA) organized a virtual conference on February 2, 2023 to promote the development of RNA-based medicines. The initiative addresses the goal of the EMA Regulatory Science Strategy to 2025 to "catalyse the integration of science and technology in medicines development." The conference focused on RNA technologies (excluding RNA vaccines) and involved different stakeholders, including representatives from academia, industry, regulatory authorities, and patient organizations. The conference comprised presentations and discussion sessions conducted by panels of subject matter experts. In this meeting report, we summarize the presentations and recap the main themes of the panel discussions.

CRISPR-Cas technology has revolutionized microbiome research by enabling precise genetic manipulation of microbial communities. This review explores its diverse applications in gut microbiome studies, probiotic development, microbiome diagnostics, pathogen targeting, and microbial community engineering. Engineered bacteriophages and conjugative probiotics exemplify CRISPR-Cas's capability for targeted bacterial manipulation, offering promising strategies against antibiotic-resistant infections and other gut-related disorders. CRISPR-Cas systems also enhance probiotic efficacy by improving stress tolerance and colonization in the gastrointestinal tract. CRISPR-based techniques in diagnostics enable early intervention by enabling fast and sensitive pathogen identification. Furthermore, CRISPR-mediated gene editing allows tailored modification of microbial populations, mitigating risks associated with horizontal gene transfer and enhancing environmental and health outcomes. Despite its transformative potential, ethical and regulatory challenges loom large, demanding robust frameworks to guide its responsible application. This chapter highlights CRISPR-Cas's pivotal role in advancing microbiome research toward personalized medicine and microbial therapeutics while emphasizing the imperative of balanced ethical deliberations and comprehensive regulatory oversight., (Copyright © 2024. Published by Elsevier Inc.)

Introduction: The implementation of pharmacogenetic analysis within clinical trials faces methodological, ethical, and regulatory challenges, as well as tackling the difficulty in obtaining actionable information with a sufficient level of evidence to enable its integration into routine clinical practice., Areas Covered: We discuss the current status of pharmacogenetics integration in clinical trials, underscore the associated challenges, and make some suggestions on the aspects to address in any clinical trial including a pharmacogenetic evaluation. We conducted a literature review, thoroughly reviewed the applicable regulations and available guidelines, and assessed the application dossiers submitted for evaluation to the Ethics committee of Hospital La Paz (Madrid, Spain) to extract information related to inclusion of pharmacogenetics evaluations., Expert Opinion: The integration of pharmacogenetics into clinical trials is becoming increasingly common. However, several regulatory, methodological and ethical aspects involved are insufficiently addressed. There is a need for specific and transparent guidelines that establish unified and compliant criteria for methodology, proper handling of samples in compliance with regulations, and the protection of data privacy and confidentiality. Participants should receive complete and appropriate information regarding the purpose, handling, storage, and transfer of their samples and data, and should have the right to decide about their processing.

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., Competing Interests: Marline Kirsch and Jordi Morales‐Dalmau are employees of Cultimate Foods UG (Berlin/Göttingen). However, the authors declare that they wrote this review objectively and without bias. The company did not influence manuscript preparation. No other conflicts of interest exist., (© 2023 The Authors. Engineering in Life Sciences published by Wiley‐VCH GmbH.)

New horizons in cardiovascular research are opened by using 3D printing for biodegradable implants. This additive manufacturing approach allows the design and fabrication of complex structures according to the patient's imaging data in an accurate, reproducible, cost-effective, and quick manner. Acellular cardiovascular implants produced from biodegradable materials have the potential to provide enough support for in situ tissue regeneration while gradually being replaced by neo-autologous tissue. Subsequently, they have the potential to prevent long-term complications. In this Review, we discuss the current status of 3D printing applications in the development of biodegradable cardiovascular implants with a focus on design, biomaterial selection, fabrication methods, and advantages of implantable controlled release systems. Moreover, we delve into the intricate challenges that accompany the clinical translation of these groundbreaking innovations, presenting a glimpse of potential solutions poised to enable the realization of these technologies in the realm of cardiovascular medicine.

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.

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.

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-HT 1A 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., (© 2021 The British Pharmacological Society.)

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., 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., (Copyright © 2022 Shah, Lalan and Barve.)

Cancer therapy has undergone a drastic revolution in the past few decades with the introduction of several novel therapies, like immunotherapy (active and passive), stem cell-based therapies, and nanocarrier-based therapies. These therapies have addressed the issues of conventional cancer therapy (chemotherapy or radiotherapy), like specificity and off-target effects. Further, the introduction of such treatments has improved survival and converted a terminal disease into a more manageable condition. However, many clinical, ethical, and regulatory issues are raised with such novel additions. Several effective therapies are under research but could not come to market or are delayed due to regulatory concerns for marketing approval. The scope of this review encompasses the examination of these regulatory issues and discuss their possible solutions. A practical and flexible regulatory approach, harmonized globally, could help the patients suffering from a terminal illness to lead a quality life., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Herbal medicines play an important role in treating various ailments due to their potentially high therapeutic values and acceptability by patients with different health complications. The practice of herbal medicine involves the use of a part of a plant, the entire plant, or a selective isolated phytoconstituent. The search for new drugs during the scientific era revived the interest in the discovery of herbal drugs from different natural resources. The present modern healthcare system involves the utilization of drugs and 50% of them are of natural origin. In recent years, there had been an upsurge in the interest for search of novel herbal drugs by the pharmaceutical industry. However, the discovery of such new novel phytomedicines involves various challenges in the identification of active constituents; their characterization, pharmacological activity, toxicity/adverse effects, drug interactions, and, most importantly, their regulatory requirements. The present review is mainly focused on the history of herbal medicine, current clinical perspective, and pharmaceutical and regulatory challenges facing herbal drugs. Moreover, problems encountered in drug discovery from herbal resources and their possible solutions have been delineated., (Copyright© Bentham Science Publishers; For any queries, please email at epub@benthamscience.net.)

The emergence of multi-drug resistant bacteria has limited therapeutic options for the treatment of bacterial diseases in both human and veterinary medicine. This has resulted in an urgent need for novel agents to treat infectious diseases. Veterinary medicine is further constrained by the need to ensure that our emerging therapeutics have minimal or no impact on resistance in human pathogens. Thus, there has recently been increased attention given to the development of alternative treatments for infectious disease in animals. The domain of alternative therapies, which includes antimicrobial peptides, bacteriophages, probiotics, and immunomodulators, provides a means to directly inhibit the ability of a pathogen to damage the host while optimally, not imposing a selective pressure favouring antibiotic resistance. However, it is recognized that bacterial pathogens have the capability of expressing a variety of virulence factors, necessitating a clear understanding of the specific target for that therapeutic intervention. This manuscript explores the various virulence mechanisms, the potential utility of developing novel anti-virulence agents for counteracting the expression of diseases associated with veterinary species, and some of the unique regulatory hurdles to be addressed within the framework of a new animal drug application. We conclude with the public health concerns to be considered as these agents are integrated into the veterinary therapeutic arsenal. Our hope is that this manuscript will provide a platform to stimulate discussions on the critical questions that need to be addressed., (Published by Elsevier Ltd.)

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., Competing Interests: Johanna T. Dwyer holds stock in several food and drug companies, and serves on the scientific advisory boards of Conagra Foods, McCormick Spices, and as a consultant for Gerber/Nestle. She accepted partial travel and per diem expenses to speak at a symposium on dietary supplements sponsored by the International Association of Dietary/Food Supplement Associations at the International Congress of Nutrition in Buenos Aires, Argentina in October 2017. Michael J. Smith holds stock in several food and drug companies as well as acting as a consultant with clients in both the private and public sector including companies in dietary supplement and natural health products sector. He sits on the scientific advisory board of ISURA and the advisory board of the American Botanical Council. Paul M. Coates reports no conflicts of interest.

Dietary supplements, including those containing botanical ingredients and botanical-derived compounds, have been marketed to consumers globally for many decades. However, the legislative framework for such products remains inconsistent across jurisdictions internationally. This study aims to compare the regulatory framework of botanical food supplements in the EU, USA, Canada, Australia, New Zealand, India, Japan, and China. The study also aims to investigate and describe safety assessment criteria for botanical food supplements where they are present in the above said jurisdictions, and attempts to analyze whether these criteria are suitable for addressing the toxicological risks associated with the use of botanical food supplement products, based on the evaluation of reported adverse effects related to botanical food supplement use as examples. Finally, this study discusses some future issues that need further attention, such as the consideration of less than lifetime exposures, potential for misidentification, and adulteration of botanical supplements by pharmacologically active substances. It is concluded that the regulatory approaches towards botanical food supplements differ significantly across jurisdictions. In addition, national authorities are increasingly considering having more regulatory oversight for such products. Further consideration of the actual impact of adverse events arising from botanical food supplement usage will be helpful in guiding such decisions., (© 2017 Institute of Food Technologists®.)

The influence of nanoparticle (NP) formulations on the pharmacokinetic, pharmacodynamic and biodistribution profiles of peptide- and protein-like drugs following oral administration is critically reviewed. The possible mechanisms of absorption enhancement and the effects of the physicochemical properties of the NP are examined. The potential advantages and challenges of physiologically-based pharmacokinetic (PBPK) modelling to help predict efficacy in man are discussed. The importance of developing and expanding the regulatory framework to help translate the technology into the clinic and accelerate the availability of oral nanoparticulate formulations is emphasized. In conclusion, opportunities for future work to improve the state of the art of oral nanomedicines are identified., (Copyright © 2016 Elsevier B.V. All rights reserved.)

Personalized medicine has captured the attention of the public, including patients, healthcare providers, scientists, medical product manufacturers and many others. The US FDA will evaluate many of the products that will allow personalized medicine to be successfully implemented in the USA. This article addresses the FDA's approach to regulation of one component of personalized medicine, in vitro diagnostic devices. It also describes the FDA's efforts to integrate the various medical product regulatory authorities provided by Congress in the Federal Food, Drug and Cosmetic Act to develop effective mechanisms for oversight of medical products used to personalize treatment. Finally, it presents some of the current challenges in in vitro diagnostics oversight that may be of interest for personalized medicine.