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Journal of Cutaneous Medicine and... 2022Soft Tissue Filler (STF) Therapy for cosmetic facial rejuvenation is associated with known complications. The manifestation of these known complications can lead to... (Review)
Review
Soft Tissue Filler (STF) Therapy for cosmetic facial rejuvenation is associated with known complications. The manifestation of these known complications can lead to patients commencing civil litigation actions or making complaints to provincial regulatory authorities and alleging that the practitioner failed to obtain the patient's informed consent to the therapy. Data provided by the Canadian Medical Protective Association (CMPA) on medical-legal cases arising from the provision of STF therapy between 2005 and 2019 are presented. Select reported case law decisions from Canadian courts and regulatory bodies addressing the concept of informed consent are reviewed. Insights about the risk factors pertaining to the process of obtaining informed consent for STF therapy are presented to increase an understanding of the elements of communication and documentation needed to ensure patients are aware of the consequences of this treatment.
Topics: Canada; Cosmetic Techniques; Dermal Fillers; Face; Humans; Informed Consent; Malpractice
PubMed: 34310242
DOI: 10.1177/12034754211032542 -
Brain Tumor Research and Treatment Jul 2023The three-dimensional (3D) printing itself is not a novel technology, it is more than 30 years old. Stereolithographic (SLA) technology has been used as the first and... (Review)
Review
The three-dimensional (3D) printing itself is not a novel technology, it is more than 30 years old. Stereolithographic (SLA) technology has been used as the first and popular technology for medical application of 3D printing. Since 1991 and have published articles about SLA for rapid prototyping anatomical 3D models. Medical applications of 3D printing have been popularizing and stabilizing so far. Implantable medical devices such as metal or absorbable implants, surgical guide systems, prosthesis and orthosis, and 3D anatomical models for normal or diseased anatomy have been developing and expanding its markets so far. There are many obstacles, such as insurance, authorization as a medical device, and lack of standards technology for further expansion of medical applications. Many technical specifications and guidelines for authorization as medical device have been published by regulatory bodies from many countries. Even though international standards for 3D printing have been developing more and more, there have been few standards for medical application of 3D printing. In this harsh environment academia, company, research institute, regulatory bodies, and government have been doing good job for the development of 3D printing industry.
PubMed: 37550814
DOI: 10.14791/btrt.2023.0001 -
Human Vaccines & Immunotherapeutics Dec 2024The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other... (Review)
Review
The pandemic caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) led to urgent actions by innovators, vaccine developers, regulators, and other stakeholders to ensure public access to protective vaccines while maintaining regulatory agency standards. Although development timelines for vaccines against SARS-CoV-2 were much quicker than standard vaccine development timelines, regulatory requirements for efficacy and safety evaluations, including the volume and quality of data collected, were upheld. Rolling review processes supported by sponsors and regulatory authorities enabled rapid assessment of clinical data as well as emergency use authorization. Post-authorization and pharmacovigilance activities enabled the quantity and breadth of post-marketing safety information to quickly exceed that generated from clinical trials. This paper reviews safety and reactogenicity data for the BNT162 vaccine candidates, including BNT162b2 (Comirnaty, Pfizer/BioNTech COVID-19 vaccine) and bivalent variant-adapted BNT162b2 vaccines, from preclinical studies, clinical trials, post-marketing surveillance, and real-world studies, including an unprecedentedly large body of independent evidence.
Topics: Humans; BNT162 Vaccine; COVID-19; COVID-19 Vaccines; Marketing; Pharmacovigilance; SARS-CoV-2; Vaccines, Combined
PubMed: 38407186
DOI: 10.1080/21645515.2024.2315659 -
Exploratory Research in Clinical and... Sep 2022Coronavirus disease 2019 (COVID-19) is rapidly evolving with millions of cases and death reported globally. The first-ever case of COVID-19 in Bhutan was confirmed on 5...
Coronavirus disease 2019 (COVID-19) is rapidly evolving with millions of cases and death reported globally. The first-ever case of COVID-19 in Bhutan was confirmed on 5 March 2020 in a 76-year-old American tourist. The national regulatory authorities have implemented varying degrees of regulatory flexibilities to prevent unnecessary death by ensuring timely access to medical products and technologies during the pandemic. The Drug Regulatory Authority of Bhutan, as a national medicines regulatory agency responsible for ensuring the quality of medical products has implemented several regulatory mechanisms to ensure access to medical products including COVID-19 vaccines during the pandemic. In this commentary, we discuss the regulatory flexibilities that ensured access to medical products and COVID-19 vaccines during the pandemic.
PubMed: 35859611
DOI: 10.1016/j.rcsop.2022.100156 -
Frontiers in Medicine 2022ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300...
INTRODUCTION
ZaZiBoNa, the work-sharing initiative in the Southern African Development Community (SADC) that has been in operation for 8 years has successfully assessed over 300 dossiers/applications, with an overall median time to recommendation of 12 months. All 16 SADC countries participate in the initiative as either active or non-active members. While the successes of ZaZiBoNa are evident, some challenges still exist. The aim of this study was to solicit the views of the participating authorities on the effectiveness and efficiency of the current operating model of the ZaZiBoNa initiative.
METHODS
Data were collected in 2021 using the Process, Effectiveness and Efficiency Rating (PEER) questionnaire developed by the authors. The questionnaire was completed by the focal person in each country and approved by the head of the authority.
RESULTS
ZaZiBoNa serves as a platform for work sharing, information exchange, capacity building and harmonisation of registration requirements. One of the benefits to regulators has been the improvement in the capacity to conduct assessments. Manufacturers have benefited from compiling one package (modules 2-5) for the initial submission as well as a single response package to the consolidated list of questions, which saves time and resources. Respondents were of the view that patients have benefited as the ZaZiBoNa has contributed to an improved availability and accessibility to quality-assured medicines. Some of the challenges identified were the inadequacy of resources and differences in time to the implementation of ZaZiBoNa recommendations by the individual countries. The establishment of a regional unit hosted in one of the member countries to enable centralised submission and coordination was identified as the best strategy to improve the effectiveness and efficiency of the initiative in the interim, with the long-term goal being the establishment of a regional medicines authority.
CONCLUSION
The study identified the strengths of the ZaZiBoNa initiative as well as the opportunities for improvement. The recommendations made would further strengthen this initiative.
PubMed: 35547217
DOI: 10.3389/fmed.2022.898743 -
Therapeutic Innovation & Regulatory... Mar 2024This qualitative study aims to analyze current PM regulation and market access requirements and proposes potential solutions to mitigate current challenges.
OBJECTIVES
This qualitative study aims to analyze current PM regulation and market access requirements and proposes potential solutions to mitigate current challenges.
METHODS
Twenty-two semi-structured interviews were conducted with experts from pharmaceutical industry, regulatory authorities, national health technology assessment (HTA) bodies, pediatricians, and academia from the Netherlands (NL), Germany (DE), the United Kingdom (UK), and France (FR) to get insight into the pediatric research, the regulatory and reimbursement processes, challenges, and solutions. Themes for further testing were developed on how to facilitate pediatric market access. Atlas.ti 9 was used to analyze the findings.
RESULTS
Heterogeneity in requirements for the European Medicines Agency (EMA) and HTA approvals are noted. By example, DE grants direct reimbursement after regulatory approval, the other countries require additional reimbursement which generate delays and challenges in patient access after marketing authorization. Key components in facilitating PM market access include multi-stakeholder collaboration, transparency, patient representatives, informed consent guidance, real-world evidence, and appropriate clinical trial designs. Pricing models based on the economic capabilities of individual countries could further reduce delays and challenges in market access. The additional specific pediatric incentives should be taken as best practice to encourage innovation in pediatric conditions.
CONCLUSION
This study highlights differences in requirements for regulatory and reimbursement approval, along with international differences in pricing and reimbursement procedures for pediatric market access.
Topics: Child; Humans; Costs and Cost Analysis; Germany; United Kingdom; Qualitative Research
PubMed: 38172379
DOI: 10.1007/s43441-023-00601-6 -
Heliyon Jul 2023Cities in the global south, constrained by limited resources, face challenges in delivering efficient transportation infrastructure and services to support their rapidly... (Review)
Review
Cities in the global south, constrained by limited resources, face challenges in delivering efficient transportation infrastructure and services to support their rapidly growing urban populations. Dhaka, serves as an example, as it grapples with the increasing demand driven by population growth, exacerbated by factors like land and resource scarcity, as well as intricate geopolitical dynamics. Despite the construction of a metro rail and other similar mass transit options, Dhaka continues to face difficulties in meeting the increasing transportation demand, posing a persistent challenge. Multiple institutions, including a coordination authority, are working to provide improved transportation services by implementing diverse strategic approaches focusing on infrastructure development, and formulating policies aimed at facilitating better mobility and accessibility. Over the past fifty years, the institutional arrangement and roles within the transportation system have changed. This study examines the institutional arrangements and how they have evolved, along with reviewing transportation development policies during this period. The findings indicate the involvement of multiple organizations in the city's transportation system performing distinct activities-- administrative, coordinating, legislative, regulatory, construction and management, and law enforcement. These authorities often encounter challenges fulfilling their responsibilities stemming from differences in vision, organizational structure, jurisdiction and most notably, lack of coordinatoon, resulting in ineffective infrastructure development and duplicated activities. To improve the transportation system, this study recommends better equipping the existing coordinating authority and expanding its jurisdiction to include other institutions. This approach aims to enhance coordination and address the challenges faced by Dhaka's transportation system, ultimately facilitating improved mobility and accessibility for the city's growing population.
PubMed: 37456001
DOI: 10.1016/j.heliyon.2023.e17887 -
Diabetes Technology & Therapeutics Jul 2015Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with... (Review)
Review
Insulin analog patent expiry is likely to mean that, increasingly, copies of original biopharmaceutical products will be submitted for authorization. Experience with biosimilars in other therapeutic areas suggests that careful regulation and caution are needed. Published guidelines of regulatory authorities around the world on approval of biosimilars and, where available, insulin biosimilars were reviewed. Information was sourced through Internet searching and cross-referencing guidelines. As of August 2014, general biosimilar and insulin-specific guidelines are available in 34 countries and two countries/regulatory domains, respectively. Many guidelines are clearly related to, or partly derived from, the general and insulin-specific European Medicines Agency (EMA) guidelines. Areas covered by these guidelines are fairly consistent, covering preclinical, pharmacokinetic (PK), and pharmacodynamic (PD) studies in humans and clinical areas; however, there are differences in emphasis. The EMA insulin-specific guidelines include detailed criteria on PK/PD studies, as do most other general biosimilar guidelines and, to a lesser extent, clinical studies. The U.S. Food and Drug Administration has general biosimilar guidelines, emphasizing consideration of the whole package of in vitro, biological, and human studies, rather than concentrating on any one aspect. In countries such as Mexico, guidelines are broad, leaving wide discretion to the regulatory authority. In conclusion, from a global perspective, this area of drug regulation is heterogeneous and evolving, and the authors call for an initiative aimed at harmonizing the requirements for biosimilar insulins.
Topics: Biosimilar Pharmaceuticals; Drug Approval; Europe; Humans; Insulins; Mexico; United States; United States Food and Drug Administration
PubMed: 25789689
DOI: 10.1089/dia.2014.0362 -
Transnational Legal Theory 2022This article puts forward an approach to account for the evolution of transnational private rule-makers. Morphing of organisations, procedures, and rules is suggested as...
This article puts forward an approach to account for the evolution of transnational private rule-makers. Morphing of organisations, procedures, and rules is suggested as a key strength of various forms of private authority. Directing attention towards evolutionary dynamics, and their impact on the goals pursued by transnational private regulators, as well as on the implications for targets and beneficiaries of their rules, brings forward various implications of transnational private regulators. These implications include tensions between the complementary and competitive relations between public and private authority, and question the capacity of the former to effectively enrol, steer and influence the latter. The article discusses the role of regulatory and organisational crises as catalysts for the emergence and evolution of transnational private rule-makers, and how crises affect the relation between public and private regimes. Finally, we reflect on possible competitive challenges that emerge by employing a dynamic perspective to transnational private regulation.
PubMed: 36999165
DOI: 10.1080/20414005.2023.2178143