Journal of Regulatory Science最新文献

{"title":"A Review of COVID-19 Vaccine Adverse Event Following Immunization Case Reports by four CARICOM Countries to VigiBase","authors":"Danini Marin","doi":"10.21423/jrs.regsci.121283","DOIUrl":"https://doi.org/10.21423/jrs.regsci.121283","url":null,"abstract":"The World Health Organization declared COVID-19 a pandemic on 12 March 2020. One of the strategies to combat the pandemic was the development of novel COVID-19 vaccines. Once these vaccines were deployed, immunizations followed. The objective of this study was to identify the characteristics of case reports of adverse events following immunization (AEFIs) with COVID-19 vaccines based on Individual Case Safety Reports (ICSRs) in VigiBase, submitted by four CARICOM countries: Barbados, Haiti, Jamaica and St. Vincent and the Grenadines. A review of the publicly available data on AEFIs with COVID-19 vaccines based on ICSRs in VigiBase was conducted from March 1, 2021 to December 14, 2022. A total of 1,582 AEFI case reports were identified for this period. Most of these were non-serious events, involving persons under 65 years (84.9%), and females (74.1%); 19% were classified as serious events. The top age group reported for AEFIs in VigiBase were 18-44 years (46.6%). The most frequently reported reactions were headache (29.3%), pyrexia (19.3%), dizziness (19.3%). Altogether for the four countries, the AEFIs per 100,000 doses was 64.1 and 12.2 serious AEFIs per 100,000 doses. Recommended actions identified were strengthening national pharmacovigilance regulatory frameworks, establishing robust national pharmacovigilance centres, capacity building of professionals, enhancing communication with key stakeholders and consider relying in a regional pharmacovigilance system.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"65 4","pages":""},"PeriodicalIF":0.0,"publicationDate":"2024-07-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141652515","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory Science: The Maturation of an Evolving Scientific Discipline","authors":"A. A. Moghissi, Tomoko Steen, Richard A. Calderone, Jean-Pierre Auffret, Lisa M. Jaeger, Liwei Sarah Xu, Carolyn Wixson McBride, Dennis McBride","doi":"10.21423/jrs.regsci.111272","DOIUrl":"https://doi.org/10.21423/jrs.regsci.111272","url":null,"abstract":"Regulatory science encompasses the participation of a large array of scientific disciplines involved in the regulatory process. Although each discipline addresses different phenomenology and exploits different methodologies, the common scientific core is the same:  objective pursuit of verifiable and useful knowledge.  This paper updates the definition and scope of the practice of regulatory science, starting with a concise historical overview. It then examines the different phases of regulatory science applications: initial, exploratory, and standard operating. The paper also reviews the definitions of regulatory science used by various agencies and provides abbreviated scientific definitions. The paper summarizes Best Available Regulatory Science (BARS) and Metrics for Evaluation of Scientific Claims (MERSC), along with key elements and tools of regulatory science: peer review; regulatory science ethics, including the so-called Jeffersonian principle; mathematical models; cost benefit analysis; and stakeholder participation. The paper concludes with a brief description of these key tools and elements, highlighting their importance in the field of regulatory science.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"31 12","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-11-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139272440","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Biomass degradation after harvest of genetically modified products compared to conventional counterparts","authors":"Hallison Vertuan, Marcia José, Augusto Crivellari, Gustavo G. Belchior, Luciana Verardino, Daniel J. Soares, L. F. Bellini, Fabiana Bacalhau, Marcos Barancelli, Daniel Sordi, Geraldo Berger","doi":"10.21423/jrs.regsci.111186","DOIUrl":"https://doi.org/10.21423/jrs.regsci.111186","url":null,"abstract":"Conventional breeding and modern biotechnology tools have been successfully combined over the years to generate GM crops. Single events have been crossed to generate stacked products and these combinations have proven to be an effective way to combine different gene products and associated characteristics which are agronomically relevant and result in yield increase. Regulatory agencies around the world still require risk assessment data for these products while no evidence-based additional biosafety concerns have emerged in over 20 years of global use. As part of the environmental risk assessment to evaluate the biosafety of GMOs, the Brazilian regulatory agency requests biomass degradation analyses of GM plants compared to their conventional counterparts. Here we present results on the evaluation of biomass degradation of GM and non-GM crops for soybean, maize and cotton, including single events and stacked products. Field trials were performed in representative cultivated areas in Brazil to generate biomass samples after harvest. Stalks, senescent leaves and stems after harvest were considered the biomass assessed. Collected samples were used in degradation studies conducted in a greenhouse setting from 2012 to 2019. For each product, data was subjected to analysis of variance and pairwise differences between GM and conventional counterparts were assessed with a 5% significance level. Our results show that single events and stacked products of soybean, maize and cotton presented no significant differences from their conventional counterparts for biomass degradation. This adds to the existing weight of evidence that indicates that single and stacked GM crops follow the same pattern of biomass degradation compared to conventional counterparts.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"55 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-10-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139314640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Enabling Pharmaceutical Traceability in The Nigerian Supply Chain using GS1 Global Standards: Lean Traceability Including In-Country Serialization of COVID-19 Vaccines","authors":"Mojisola Adeyeye, John Kayode, Adekunle Adeniran, Folashade Osho, Walter Udokwelu","doi":"10.21423/jrs.regsci.111252","DOIUrl":"https://doi.org/10.21423/jrs.regsci.111252","url":null,"abstract":"Traceability of the pharmaceutical products across a supply chain creates an environment that provides visibility of the product status from plant to patient.  The supply chain is the trade journey products make to consumers or retail stores (e.g. pharmacy store, patented drug store, medical store etc.,) via a network of producers, manufacturers, distributors, transporters and vendors taking that product from creation to delivery. Some of the key benefits of introducing traceability in the Nigerian pharmaceutical sector besides securing the supply chain includes an increment in the quality of data to support pharmacovigilance, decrease in the presence of substandard and falsified (SF) medications and ultimately ensuring patient safety. The drug distribution system in Nigeria is largely undefined and there have been in-country efforts to sanitize it. One such effort has produced a national policy document referred to as the Nigeria Pharmaceutical Traceability Strategy which stipulates the plan to achieve supply chain visibility, prevent infiltration of the SFs and strengthen existing regulatory and legal frameworks in Nigeria using GS1 global standards. The National Agency for Food and Drug Administration and Control (NAFDAC) and other drug regulatory agencies in Africa jointly signed a Call to Action during the 2nd GS1 African Healthcare Conference held in Lagos, Nigeria on September 16-20, 2019 to demonstrate commitment to pursue pharmaceutical traceability by adopting global supply chain standards. This article focuses on how NAFDAC in collaboration with GS1 Nigeria, National Primary Health Care Development Agency (NPHCDA) and other partners have implemented traceability as a public sector pilot for the COVID-19 vaccines received in Nigeria from March 2021 to December 2021.  This included the serialization of COVID-19 vaccines that were received without serial numbers that uniquely identify the secondary packing of the COVID-19 vaccines. The lessons learned from the pilot would be used to support development and dissemination of tracebility regulation, publish guidelines for traceability implementation, and engage stakeholders meaningfully as Nigeria implements full track and trace of pharmaceutical products.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"30 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2023-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"139339220","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Putting It in Writing","authors":"Somya Gupta, Farhat Ahmed, Ramya Krishnadas","doi":"10.21423/jrs.regsci.111266","DOIUrl":"https://doi.org/10.21423/jrs.regsci.111266","url":null,"abstract":"In the medical device industry, the practice of creating a \"Letter to File,\" \"Note to File,\" or \"Memo to File\" is employed to document modifications to a device in the USA for regulatory and compliance purposes. Although the U.S. Food and Drug Administration (FDA) have provided guidance on this topic over the years, there has not been a thorough exploration of this concept. Medical device manufacturers frequently make changes to their FDA-cleared products, but determining whether to handle the change internally using a Letter to File or notify the FDA can be unclear. This article provides a comprehensive overview of what a Letter to File is, the purpose of writing one, and the appropriate situations in which a company might use it. Additionally, it also discusses the contents of a typical Letter to File, including the necessary elements and the best practices for writing it effectively and consequences of making the wrong decision. By providing guidance on the Letter to File process, this article aims to assist professionals in the medical device industry in maintaining precise records that can support their organizations in any regulatory situation.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"17 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-04-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"129759555","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Use of a Portable X-Ray Fluorescence Analyzer for Rapid and Accurate Determination of Iron in Vitamins and Supplements","authors":"","doi":"10.21423/jrs.regsci.102258","DOIUrl":"https://doi.org/10.21423/jrs.regsci.102258","url":null,"abstract":"This study describes the development of an X-Ray Fluorescence (XRF) method to quantify iron in vitamins and supplements. Four different products and a NIST Standard Reference Material (SRM) were prepared by homogenizing 20 tablets in a mixer mill and diluting known masses of each sample into known masses of cellulose. Calibration standards were similarly prepared by diluting known masses of iron oxide into known masses of cellulose. Analyses were performed using a handheld XRF analyzer using one-minute analysis times. The method gave linear calibration curves with R2 values greater than 0.9995, and good accuracy as demonstrated by relative errors of 9% in the analysis of the NIST SRM. Experimentally determined concentrations of the samples were compared to the nominal concentration of the samples based on the mass of iron per tablet and the average tablet mass. XRF results gave relative differences of +4% and -4% for two iron supplements. XRF results gave a larger relative difference of -19% for the women’s vitamin product. Although the label on the men’s vitamin product stated it was iron-free, XRF and Microwave Plasma Atomic Emission Spectrometry (MP-AES) analyses showed it contained iron levels of 157 and 133 µg/g (ppm), respectively. This XRF method offers a simpler, faster, and less expensive alternative to conventional atomic spectrometry-based methods for this type of application.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"1 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"130374661","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Portable Spectroscopy for Food Safety and Adulteration Screening","authors":"Joshua Moskowitz, Betsy Jean Yakes","doi":"10.21423/jrs.regsci.102257","DOIUrl":"https://doi.org/10.21423/jrs.regsci.102257","url":null,"abstract":"In this review we discuss various applications of portable vibrational spectroscopy in food adulteration analyses and authentication confirmation. These applications generally involve the adulteration of a food product with materials which may be of lesser monetary value and may also be detrimental to human health. Portable spectroscopic testing for food authentication opens potential for rapid and on-site analyses of food products at various stages in the food production chain. These portable techniques also require the development of data analysis methods for each individual application, which will also be discussed in this review. Specific food safety applications for portable spectroscopy to be discussed include adulteration detection and evaluation of authenticity. Adulteration detection examples focus on the commonly adulterated milk powder and spice commodities, as well as the potential for component substitution (e.g., artificial sweeteners). For authentication, examples from marine oil dietary supplements, olive oils, honeys, coffees, and grains are presented along with examples of speciation (e.g. fish) and growth conditions (bell peppers).","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"129 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"122428259","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Repercussions of politicized regulation exemplified by compulsory new TC1507-maize 90-day rat feeding study","authors":"","doi":"10.21423/jrs-v10a192","DOIUrl":"https://doi.org/10.21423/jrs-v10a192","url":null,"abstract":"Politicized and prescriptive regulation of genetically modified (GM) crops has unintended adverse effects, including misdirected resources and reduced benefits.  In the case of animal testing, this suboptimal use of resources includes the needless sacrifice of animals.  Whole-food animal feeding studies are generally of negligible value in the risk assessment of GM crops, a position that was affirmed by the European Food Safety Authority (EFSA).  Contrary to EFSA’s 2011 position, in 2013, the European Commission directed that 90-day rat studies be conducted for new GM events.  As no EFSA guidance was available for hypothesis-free 90-day rat feeding studies, EFSA interpreted this as a mandate to develop a prescriptive study design.  Recently, EFSA has retroactively required 90-day rat studies be completed under new study guidelines for previously approved component single events as part of the approval of breeding stacks.  Having been unable to secure a derogation (exemption) from EFSA, a new compulsory 90-day rat study was conducted with TC1507 maize to support a breeding-stack submission.  As previously shown, TC1507 maize does not adversely affect rats.  This politically driven additional animal testing is risk disproportionate, at odds with European and international standards for animal welfare, and provides no scientific value to the safety assessment for GM breeding stacks.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"199 ","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"132914303","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"How Protective is the Pesticide Risk Assessment and Registration Process to Humans in the United States?","authors":"Raghavendhran Avanasi, Aubrey Glover, Caleb C. Lord, Jessica Macari, M. Munday, Carol McKillican, Nestor Algarin, Amy J. McCaskill, Ronald Hampton, R. Brain, Kevin A. Leiner","doi":"10.21423/jrs.regsci.111249","DOIUrl":"https://doi.org/10.21423/jrs.regsci.111249","url":null,"abstract":"The need to feed the growing world population is a daunting challenge and improving crop yield using technology (e.g., synthetic pesticides) is a primary solution being utilized by growers globally. However, there is a general perception that the U.S. population is not well protected from the effects of using pesticides. This leads us to a natural question: how protective to humans is the pesticide risk assessment and registration process in the U.S.? In this commentary, we aim to give an overview of the regulatory history of pesticides in the U.S. and systematically discuss the data-driven, comprehensive, and health-protective methods employed by the U.S. Environmental Protection Agency (EPA) in accordance with the stringent mandates of the laws passed by U.S. Congress and the regulations enacted by the EPA to protect the U.S. population. By describing the studies required under the Code of Federal Regulations (CFR), along with the health-protective models and assumptions employed by the EPA to evaluate the potential for human health risks from pesticides, we aim to highlight the compounding health-protectiveness of the existing regulatory framework. We emphasize the need to maintain a regulated risk-benefit balance in using modern agricultural technology, similar to what is done with other indispensable modern human innovations and technologies.      ","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"92 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"125856306","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Regulatory Compliance and Quality Programs: Constraints and Opportunities for Integration","authors":"Brian Freer, Richard Fiene","doi":"10.21423/jrs.regsci.111264","DOIUrl":"https://doi.org/10.21423/jrs.regsci.111264","url":null,"abstract":"Management systems for regulatory compliance and quality programs are examined in this paper from the standpoint of their potential integration and in terms of the concept of a process. The paper identifies five common drags on management system optimization and outlines a scoring system that organizations may use to evaluate their management systems for potential adoption of an integrated process-based program.","PeriodicalId":263660,"journal":{"name":"Journal of Regulatory Science","volume":"38 1","pages":"0"},"PeriodicalIF":0.0,"publicationDate":"2023-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"135146576","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}