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1.
Biomed Eng Online ; 19(1): 75, 2020 Oct 02.
Artigo em Inglês | MEDLINE | ID: mdl-33008462

RESUMO

BACKGROUND: The world is facing an unprecedented outbreak affecting all aspects of human lives which is caused by the COVID-19 pandemic. Due to the virus novelty, healthcare systems are challenged by a high rate of patients and the shortage of medical products. To address an increased need for essential medical products, national authorities, worldwide, made various legislative concessions. This has led to essential medical products being produced by automotive, textile and other companies from various industries and approved under the emergency use authorizations or legal concessions of national regulatory bodies. This paper presents a narrative commentary of the available documentation on emergency use authorizations and legal concessions for medical products during COVID-19 pandemic. METHODOLOGY: The basis for narrative commentary includes scientific articles published in Web of Science, Scopus, PubMed and Embase databases, official publications of international organizations: Food and Drug Agency (FDA), World Health Organisation (WHO), World Bank and United Nations (UN), and national regulatory agency reports in native languages (English, German, Bosnian, and Croatian) published from November 1, 2019 to May 1, 2020. This paper focuses on three types of essential medical products: mechanical ventilators, personal protective equipment (PPE) and diagnostic tests. Evidence-informed commentary of available data and potential identified risks of emergency use authorizations and legal concessions is presented. DISCUSSION: It is recognized that now more than ever, raising global awareness and knowledge about the importance of respecting the essential requirements is needed to guarantee the appropriate quality, performance and safety of medical products, especially during outbreak situation, such as the COVID-19 pandemic. Emergency use authorizations for production, import and approval of medical products should be strictly specified and clearly targeted from case to case and should not be general or universal for all medical products, because all of them are associated with different risk level. CONCLUSION: Presented considerations and experiences should be taken as a guide for all possible future outbreak situations to prevent improvised reactions of national regulatory bodies.


Assuntos
Betacoronavirus , Comércio/legislação & jurisprudência , Infecções por Coronavirus , Licenciamento/legislação & jurisprudência , Indústria Manufatureira/legislação & jurisprudência , Pandemias , Equipamento de Proteção Individual/provisão & distribução , Pneumonia Viral , Kit de Reagentes para Diagnóstico/provisão & distribução , Ventiladores Mecânicos/provisão & distribução , Técnicas de Laboratório Clínico/normas , Infecções por Coronavirus/diagnóstico , Falha de Equipamento , União Europeia , Saúde Global , Humanos , Equipamento de Proteção Individual/normas , Kit de Reagentes para Diagnóstico/normas , Medição de Risco , Estados Unidos , United States Food and Drug Administration , Ventiladores Mecânicos/normas
2.
Biomed Res Int ; 2020: 2606058, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-33029499

RESUMO

On March 11th, 2020, the World Health Organization declared COVID-19 infection as a pandemic. Since it is a novel virus, there are basically no proven drugs or therapies; although many laboratories in different countries are working to develop a vaccine, it will take time to make it available. Passive immunization is the therapy born from the intuition of Behring and Kisato in the late 19th century. It was widely used for the treatment of bacterial infections until the discovery of antibiotics, as well as during the viral pandemics of the 20th century and of the beginning of the 21st; it still has clinical applications (e.g., tetanus prevention). This paper summarizes the basic principles of passive immunization, with particular reference to convalescent plasma. The literature concerning its use during past epidemics and the results of the first clinical studies concerning its use during the current pandemic are discussed too. A large section is dedicated to the analysis of the possible, although rare, side effects. Recently, in 2017, the WHO Blood Regulators Network (BRN) published a position paper, recommending convalescent plasma as the first-choice treatment to be tested in the absence of authorized drugs; however, this strategy has not been followed. In the current epidemic, the principle of passive immunization through convalescent plasma has been applied in several circumstances and particularly in patients with serious complications. The first reported results are encouraging and confirm the effectiveness of plasma therapy and its safety. Also, the FDA has proposed plasma treatment in order to face the increasingly complex situation and manage patients with serious or immediately life-threatening COVID-19 disease. Several studies and clinical programs are still ongoing.


Assuntos
Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Betacoronavirus/imunologia , Infecções por Coronavirus/epidemiologia , Infecções por Coronavirus/imunologia , Humanos , Imunização Passiva/efeitos adversos , Imunização Passiva/métodos , Pandemias , Pneumonia Viral/epidemiologia , Pneumonia Viral/imunologia , Segurança , Resultado do Tratamento , Estados Unidos , United States Food and Drug Administration , Organização Mundial da Saúde
9.
Nat Commun ; 11(1): 4809, 2020 09 23.
Artigo em Inglês | MEDLINE | ID: mdl-32968055

RESUMO

Kinase inhibitors (KIs) represent an important class of anti-cancer drugs. Although cardiotoxicity is a serious adverse event associated with several KIs, the reasons remain poorly understood, and its prediction remains challenging. We obtain transcriptional profiles of human heart-derived primary cardiomyocyte like cell lines treated with a panel of 26 FDA-approved KIs and classify their effects on subcellular pathways and processes. Individual cardiotoxicity patient reports for these KIs, obtained from the FDA Adverse Event Reporting System, are used to compute relative risk scores. These are then combined with the cell line-derived transcriptomic datasets through elastic net regression analysis to identify a gene signature that can predict risk of cardiotoxicity. We also identify relationships between cardiotoxicity risk and structural/binding profiles of individual KIs. We conclude that acute transcriptomic changes in cell-based assays combined with drug substructures are predictive of KI-induced cardiotoxicity risk, and that they can be informative for future drug discovery.


Assuntos
Cardiotoxicidade/genética , Cardiotoxicidade/metabolismo , Perfilação da Expressão Gênica/métodos , Inibidores de Proteínas Quinases/efeitos adversos , Inibidores de Proteínas Quinases/farmacologia , Transcriptoma , Antineoplásicos/farmacologia , Cardiotoxicidade/tratamento farmacológico , Linhagem Celular , Relação Dose-Resposta a Droga , Aprovação de Drogas , Feminino , Expressão Gênica/efeitos dos fármacos , Humanos , Masculino , Miócitos Cardíacos/efeitos dos fármacos , Análise de Regressão , Medição de Risco , Fatores de Risco , Alinhamento de Sequência , Estados Unidos , United States Food and Drug Administration
18.
Zhongguo Yi Liao Qi Xie Za Zhi ; 44(4): 338-342, 2020 Apr 08.
Artigo em Chinês | MEDLINE | ID: mdl-32762210

RESUMO

According to users and places, blood glucose monitoring systems(BGMSs) can be divided into self-monitoring blood glucose test systems(SMBGs) and Point-of-Care Blood Glucose monitoring systems(POC-BGMSs). The Food and Drug Administration(FDA) believes that standards for SMBGs and POC-BGMSs should be different because of different operators, different use environments, different intendance uses and different applicable populations. Now the international standards for evaluating BGMSs include ISO 15197:2013 issued by International Organization for Standardization(ISO), two guidelines on blood glucose monitoring systems issued by FDA, and POCT12-A3 guidelines issued by the American Association for Clinical and Laboratory Standardization(CLSI), ISO standard and FDA guideline-OTC are applicable in SMBGs, CLSI guideline and FDA guideline-POCTI2-A3 are suitable for POC-BGMSs. By analyzing the accuracy evaluation processes of BGMSs based on four standard documents, it is found that the accuracy evaluation of medical BGMSs is more stringent. It is proposed that SMBGs and POC-BGMSs should be supervised separately.


Assuntos
Automonitorização da Glicemia , Glicemia , Sistemas Automatizados de Assistência Junto ao Leito , Padrões de Referência , Reprodutibilidade dos Testes , Estados Unidos , United States Food and Drug Administration
20.
J Anim Sci ; 98(8)2020 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-32745187

RESUMO

Proof-of-principle for large-scale engineering of edible muscle tissue, in vitro, was established with the product's introduction in 2013. Subsequent research and commentary on the potential for cell-based meat to be a viable food option and potential alternative to conventional meat have been significant. While some of this has focused on the biology and engineering required to optimize the manufacturing process, a majority of debate has focused on cultural, environmental, and regulatory considerations. Animal scientists and others with expertise in muscle and cell biology, physiology, and meat science have contributed to the knowledge base that has made cell-based meat possible and will continue to have a role in the future of the new product. Importantly, the successful introduction of cell-based meat that looks and tastes like conventional meat at a comparable price has the potential to displace and/or complement conventional meat in the marketplace.


Assuntos
Comportamento do Consumidor , Tecnologia de Alimentos , Carne/provisão & distribução , Animais , Cultura , Preferências Alimentares , Humanos , Músculo Esquelético/crescimento & desenvolvimento , Células-Tronco , Técnicas de Cultura de Tecidos , Estados Unidos , United States Food and Drug Administration
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