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[PMID]:29472192
[Au] Autor:Powers JH; Evans SR; Kesselheim AS
[Ad] Endereço:George Washington University School of Medicine, Washington, DC, USA.
[Ti] Título:Studying new antibiotics for multidrug resistant infections: are today's patients paying for unproved future benefits?
[So] Source:BMJ;360:k587, 2018 02 22.
[Is] ISSN:1756-1833
[Cp] País de publicação:England
[La] Idioma:eng
[Mh] Termos MeSH primário: Antibacterianos/uso terapêutico
Infecções Bacterianas/tratamento farmacológico
Farmacorresistência Bacteriana Múltipla
[Mh] Termos MeSH secundário: Aprovação de Drogas
Previsões
Seres Humanos
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-Bacterial Agents)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180224
[St] Status:MEDLINE
[do] DOI:10.1136/bmj.k587


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[PMID]:27772645
[Au] Autor:Jeng BH; Farid M; Patel SV; Schwab IR
[Ad] Endereço:Baltimore, Maryland. Electronic address: bjeng@som.umaryland.edu.
[Ti] Título:Corneal Cross-linking for Keratoconus: A Look at the Data, the Food and Drug Administration, and the Future.
[So] Source:Ophthalmology;123(11):2270-2272, 2016 11.
[Is] ISSN:1549-4713
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Reagentes para Ligações Cruzadas
Ceratocone/tratamento farmacológico
Fotoquimioterapia
Fármacos Fotossensibilizantes/uso terapêutico
Riboflavina/uso terapêutico
United States Food and Drug Administration/tendências
[Mh] Termos MeSH secundário: Ensaios Clínicos como Assunto
Colágeno/metabolismo
Substância Própria/metabolismo
Aprovação de Drogas
Previsões
Seres Humanos
Ceratocone/metabolismo
Projetos de Pesquisa
Raios Ultravioleta
Estados Unidos
[Pt] Tipo de publicação:EDITORIAL
[Nm] Nome de substância:
0 (Cross-Linking Reagents); 0 (Photosensitizing Agents); 9007-34-5 (Collagen); TLM2976OFR (Riboflavin)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180309
[Lr] Data última revisão:
180309
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:161025
[St] Status:MEDLINE


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[PMID]:28449973
[Au] Autor:Sandhu SK; Hua W; MaCurdy TE; Franks RL; Avagyan A; Kelman J; Worrall CM; Ball R; Nguyen M
[Ad] Endereço:Center for Biologics Evaluation and Research, Food and Drug Administration, Silver Spring, MD, USA. Electronic address: sukhminder.sandhu@fda.hhs.gov.
[Ti] Título:Near real-time surveillance for Guillain-Barré syndrome after influenza vaccination among the Medicare population, 2010/11 to 2013/14.
[So] Source:Vaccine;35(22):2986-2992, 2017 05 19.
[Is] ISSN:1873-2518
[Cp] País de publicação:Netherlands
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Guillain-Barré syndrome (GBS) is a serious acute demyelinating disease that causes weakness and paralysis. The Food and Drug Administration (FDA) began collaborating with the Centers for Medicare and Medicaid Services (CMS) to develop near real-time vaccine safety surveillance capabilities in 2006 and has been monitoring for the risk of GBS after influenza vaccination for every influenza season since 2008. METHODS: We present results from the 2010/11 to 2013/14 influenza seasons using the Updating Sequential Probability Ratio Test (USPRT), with an overall 1-sided α of 0.05 apportioned equally using a constant alpha-spending plan among 20 consecutive weekly tests, 5 ad hoc tests, and a 26th final end of season test. Observed signals were investigated using the self-controlled risk interval (SCRI) design. RESULTS: Over 15 million people were vaccinated in each influenza season. In the 2010/11 influenza season, we observed an elevated GBS risk during the season, with an end of season SCRI analysis finding a nonsignificant increased risk (RR=1.25, 95% CI: 0.96-1.63). A sensitivity analysis applying the positive predictive value of the ICD-9 code for GBS from the 2009/10 season estimated a RR=1.98 (95% CI: 1.42-2.76). Although the 2010/11 influenza vaccine suggested an increased GBS risk, surveillance of the identical vaccine in the 2011/12 influenza season did not find an increased GBS risk after vaccination. No signal was observed in the subsequent three influenza seasons. CONCLUSIONS: Conducting near real-time surveillance using USPRT has proven to be an excellent method for near real-time GBS surveillance after influenza vaccination, as demonstrated by our surveillance efforts during the 2010/11-2013/14 influenza seasons. In the 2010/2011 influenza season, in addition to the 2009 H1N1 influenza pandemic, using near real-time surveillance we were able to observe a signal early in the influenza season and the method has now become routine.
[Mh] Termos MeSH primário: Síndrome de Guillain-Barré/epidemiologia
Vacinas contra Influenza/efeitos adversos
Medicare
Vigilância da População/métodos
[Mh] Termos MeSH secundário: Idoso
Idoso de 80 Anos ou mais
Centers for Medicare and Medicaid Services (U.S.)
Sistemas de Computação
Feminino
Síndrome de Guillain-Barré/etiologia
Seres Humanos
Vacinas contra Influenza/administração & dosagem
Masculino
Medição de Risco
Estados Unidos/epidemiologia
United States Food and Drug Administration
Vacinação
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Influenza Vaccines)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170429
[St] Status:MEDLINE


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[PMID]:29232052
[Au] Autor:Chahal HS; Murray JS; Shimer M; Capella P; Presto R; Valdez ML; Lurie PG
[Ad] Endereço:Office of Public Health Strategy and Analysis, Office of the Commissioner, US Food and Drug Administration, Silver Spring, MD.
[Ti] Título:The US Food and Drug Administration's tentative approval process and the global fight against HIV.
[So] Source:J Int AIDS Soc;20(4), 2017 Dec.
[Is] ISSN:1758-2652
[Cp] País de publicação:Switzerland
[La] Idioma:eng
[Ab] Resumo:INTRODUCTION: In 2004, the US government began to utilize the Food and Drug Administration's (USFDA) tentative approval process (tFDA) as a basis to determine which HIV drugs are appropriate to be purchased and used in resource-constrained settings. This process permits products that are not approved for marketing in the US, including medicines with active patents or marketing restrictions in the US, to be purchased and distributed in resource-constrained settings. Although the tFDA was originally intended to support the United States' President's Emergency Plan for AIDS Relief (PEPFAR), the USFDA list has become a cornerstone of international HIV programmes that support procurement of ARVs, such as the World Health Organization and the Global Fund to Fight AIDS, Tuberculosis, and Malaria. Our objective in this article is to help the global HIV policy makers and implementers of HIV programmes better understand the benefits and limitations of the tFDA by providing an in-depth review of the relevant legal and regulatory processes. DISCUSSION: USFDA's dedicated tFDA process for ARVs used by the PEPFAR programme has a wide impact globally; however, the implementation and the regulatory processes governing the programme have not been thoroughly described in the medical literature. This paper seeks to help stakeholders better understand the legal and regulatory aspects associated with review of ARVs under the tFDA by describing the following: (1) the tFDA and its importance to global ARV procurement; (2) the regulatory pathways for applications under tFDA for the PEPFAR programme, including modifications to applications, review timelines and costs; (3) the role of US patents, US marketing exclusivity rights, and the Medicines Patents Pool in tFDA; and (4) an overview of how applications for PEPFAR programme are processed through the USFDA. We also provide a case study of a new ARV, tenofovir alafenamide fumarate (TAF), not yet reviewed by USFDA for PEPFAR use. CONCLUSIONS: In this paper, we describe the importance and implementation of USFDA's tentative approval process to review ARVs for resource-constrained settings. We also highlight the impact of patents and exclusivities on review of HIV drugs under tFDA and illustrate the concepts using a new HIV drug as an example.
[Mh] Termos MeSH primário: Fármacos Anti-HIV
Aprovação de Drogas
Infecções por HIV/tratamento farmacológico
[Mh] Termos MeSH secundário: Saúde Global
Seres Humanos
Cooperação Internacional
Tuberculose
Estados Unidos
United States Food and Drug Administration
Organização Mundial da Saúde
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Anti-HIV Agents)
[Em] Mês de entrada:1803
[Cu] Atualização por classe:180307
[Lr] Data última revisão:
180307
[Sb] Subgrupo de revista:IM; X
[Da] Data de entrada para processamento:171213
[St] Status:MEDLINE
[do] DOI:10.1002/jia2.25019


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[PMID]:28742291
[Au] Autor:Sultan RS; Olfson M; Correll CU; Duncan EJ
[Ad] Endereço:New York State Psychiatric Institute/Department of Psychiatry, College of Physicians and Surgeons of Columbia University, 1051 Riverside Dr, New York, NY 10032. rs3511@cumc.columbia.edu.
[Ti] Título:Evaluating the Effect of the Changes in FDA Guidelines for Clozapine Monitoring.
[So] Source:J Clin Psychiatry;78(8):e933-e939, 2017 Sep/Oct.
[Is] ISSN:1555-2101
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:BACKGROUND: Concerns exist that clozapine is underutilized in the management of treatment-resistant schizophrenia. Although a 2015 change in the US Food and Drug Administration (FDA) monitoring recommendations lowered the threshold of the absolute neutrophil count for treatment interruption from 1,500/µL to 1,000/µL and removed white blood cell count thresholds from the monitoring algorithm, the implications of this policy change on clozapine interruptions remain unknown. METHODS: We analyzed outpatient prescribing records for antipsychotic medications in the Veterans Integrated Service Network 7 (VISN 7) database between 1999 and 2012 to assess the potential impact of the recent changes in FDA neutropenia monitoring recommendations on clozapine treatment discontinuation. We evaluated results of complete blood count monitoring to compare percentages of patients who developed or would have developed ≥ 1 hematologic event under the previous and current FDA guidelines in the first year following initiation of clozapine. RESULTS: From a cohort of 14,620 patients with schizophrenia (ICD-9-295.x), 246 patients received clozapine treatment (1.7%). No agranulocytosis was observed during the study period. Under the former recommendations, 5 patients in the clozapine initiation cohort (n = 160, 3.1%; 95% CI, 0.43-5.83) qualified for treatment interruption during the first year of clozapine treatment, while only 1 patient (0.6%) qualified under the current recommendations. Under the former recommendations, hematologic events occurred at a similar rate for individuals taking and not taking clozapine. CONCLUSIONS: While clozapine remains an underused medication, the new FDA monitoring guidelines are likely to substantially reduce the percentage of patients who meet criteria for clozapine-associated hematologic events requiring treatment interruption. This decrease may reduce the clinical burden of managing patients on clozapine and therefore increase the number of individuals treated with this uniquely effective medication. However, prospective studies of individuals treated under the new guidelines are needed to fully assess safety of the FDA's change.
[Mh] Termos MeSH primário: Clozapina
Monitoramento de Medicamentos
Neutropenia
Esquizofrenia/tratamento farmacológico
[Mh] Termos MeSH secundário: Adulto
Sistemas de Notificação de Reações Adversas a Medicamentos/estatística & dados numéricos
Antipsicóticos/administração & dosagem
Antipsicóticos/efeitos adversos
Clozapina/administração & dosagem
Clozapina/efeitos adversos
Monitoramento de Medicamentos/métodos
Monitoramento de Medicamentos/estatística & dados numéricos
Prescrições de Medicamentos/estatística & dados numéricos
Feminino
Seres Humanos
Contagem de Leucócitos
Masculino
Conduta do Tratamento Medicamentoso/organização & administração
Conduta do Tratamento Medicamentoso/normas
Meia-Idade
Neutropenia/induzido quimicamente
Neutropenia/diagnóstico
Neutropenia/epidemiologia
Neutropenia/prevenção & controle
Farmacovigilância
Guias de Prática Clínica como Assunto
Escalas de Graduação Psiquiátrica
Melhoria de Qualidade
Esquizofrenia/diagnóstico
Esquizofrenia/epidemiologia
Estados Unidos/epidemiologia
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Antipsychotic Agents); J60AR2IKIC (Clozapine)
[Em] Mês de entrada:1711
[Cu] Atualização por classe:180308
[Lr] Data última revisão:
180308
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170726
[St] Status:MEDLINE


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[PMID]:28463163
[Au] Autor:Connor MJ; Tringale K; Moiseenko V; Marshall DC; Moore K; Cervino L; Atwood T; Brown D; Mundt AJ; Pawlicki T; Recht A; Hattangadi-Gluth JA
[Ad] Endereço:Department of Radiation Medicine and Applied Sciences, University of California, San Diego, La Jolla, California; University of California Irvine School of Medicine, Irvine, California.
[Ti] Título:Medical Device Recalls in Radiation Oncology: Analysis of US Food and Drug Administration Data, 2002-2015.
[So] Source:Int J Radiat Oncol Biol Phys;98(2):438-446, 2017 06 01.
[Is] ISSN:1879-355X
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:PURPOSE: To analyze all recalls involving radiation oncology devices (RODs) from the US Food and Drug Administration (FDA)'s recall database, comparing these with non-radiation oncology device recalls to identify discipline-specific trends that may inform improvements in device safety. METHODS AND MATERIALS: Recall data on RODs from 2002 to 2015 were sorted into 4 product categories (external beam, brachytherapy, planning systems, and simulation systems). Outcomes included determined cause of recall, recall class (severity), quantity in commerce, time until recall termination (date FDA determines recall is complete), and time since 510(k) approval. Descriptive statistics were performed with linear regression of time-series data. Results for RODs were compared with those for other devices by Pearson χ test for categorical data and 2-sample Kolmogorov-Smirnov test for distributions. RESULTS: There were 502 ROD recalls and 9534 other class II device recalls during 2002 to 2015. Most recalls were for external beam devices (66.7%) and planning systems (22.9%), and recall events peaked in 2011. Radiation oncology devices differed significantly from other devices in all recall outcomes (P≤.04). Recall cause was commonly software related (49% vs 10% for other devices). Recall severity was more often moderate among RODs (97.6% vs 87.2%) instead of severe (0.2% vs 4.4%; P<.001). Time from 510(k) market approval to recall was shorter among RODs (P<.001) and progressively shortened over time. Radiation oncology devices had fewer recalled devices in commerce than other devices (P<.001). CONCLUSIONS: Compared with other class II devices, RODs experience recalls sooner after market approval and are trending sooner still. Most of these recalls were moderate in severity, and software issues are prevalent. Comprehensive analysis of recall data can identify areas for device improvement, such as better system design among RODs.
[Mh] Termos MeSH primário: Recall de Dispositivo Médico
Radioterapia (Especialidade)/instrumentação
Software/estatística & dados numéricos
United States Food and Drug Administration/estatística & dados numéricos
[Mh] Termos MeSH secundário: Braquiterapia/instrumentação
Distribuição de Qui-Quadrado
Bases de Dados Factuais/estatística & dados numéricos
Equipamentos e Provisões/classificação
Equipamentos e Provisões/provisão & distribuição
Modelos Lineares
Vigilância de Produtos Comercializados/normas
Vigilância de Produtos Comercializados/estatística & dados numéricos
Radioterapia (Especialidade)/estatística & dados numéricos
Planejamento da Radioterapia Assistida por Computador/instrumentação
Planejamento da Radioterapia Assistida por Computador/estatística & dados numéricos
Estatísticas não Paramétricas
Fatores de Tempo
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Em] Mês de entrada:1707
[Cu] Atualização por classe:180307
[Lr] Data última revisão:
180307
[Sb] Subgrupo de revista:IM
[Da] Data de entrada para processamento:170503
[St] Status:MEDLINE


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[PMID]:29209711
[Au] Autor:Hwang TJ; Darrow JJ; Kesselheim AS
[Ad] Endereço:Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women's Hospital, Boston, Massachusetts.
[Ti] Título:The FDA's Expedited Programs and Clinical Development Times for Novel Therapeutics, 2012-2016.
[So] Source:JAMA;318(21):2137-2138, 2017 12 05.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Drogas/estatística & dados numéricos
United States Food and Drug Administration
[Mh] Termos MeSH secundário: Fatores de Tempo
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, NON-U.S. GOV'T
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171207
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.14896


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[PMID]:29183075
[Au] Autor:Van Wagoner RM; Eichner A; Bhasin S; Deuster PA; Eichner D
[Ad] Endereço:Sports Medicine Research and Testing Laboratory, Salt Lake City, Utah.
[Ti] Título:Chemical Composition and Labeling of Substances Marketed as Selective Androgen Receptor Modulators and Sold via the Internet.
[So] Source:JAMA;318(20):2004-2010, 2017 11 28.
[Is] ISSN:1538-3598
[Cp] País de publicação:United States
[La] Idioma:eng
[Ab] Resumo:Importance: Recent reports have described the increasing use of nonsteroidal selective androgen receptor modulators, which have not been approved by the US Food and Drug Administration (FDA), to enhance appearance and performance. The composition and purity of such products is not known. Objective: To determine the chemical identity and the amounts of ingredients in dietary supplements and products marketed and sold through the internet as selective androgen receptor modulators and compare the analyzed contents with product labels. Design and Setting: Web-based searches were performed from February 18, 2016, to March 25, 2016, using the Google search engine on the Chrome and Internet Explorer web browsers to identify suppliers selling selective androgen receptor modulators. The products were purchased and the identities of the compounds and their amounts were determined from April to August 2016 using chain-of-custody and World Anti-Doping Association-approved analytical procedures. Analytical findings were compared against the label information. Exposures: Products marketed and sold as selective androgen receptor modulators. Main Outcomes and Measures: Chemical identities and the amount of ingredients in each product marketed and sold as selective androgen receptor modulators. Results: Among 44 products marketed and sold as selective androgen receptor modulators, only 23 (52%) contained 1 or more selective androgen receptor modulators (Ostarine, LGD-4033, or Andarine). An additional 17 products (39%) contained another unapproved drug, including the growth hormone secretagogue ibutamoren, the peroxisome proliferator-activated receptor-δ agonist GW501516, and the Rev-ErbA agonist SR9009. Of the 44 tested products, no active compound was detected in 4 (9%) and substances not listed on the label were contained in 11 (25%). In only 18 of the 44 products (41%), the amount of active compound in the product matched that listed on the label. The amount of the compounds listed on the label differed substantially from that found by analysis in 26 of 44 products (59%). Conclusions and Relevance: In this limited investigation involving chemical analyses of 44 products marketed as selective androgen receptor modulators and sold via the internet, most products contained unapproved drugs and substances. Only 52% contained selective androgen receptor modulators and many were inaccurately labeled.
[Mh] Termos MeSH primário: Anabolizantes/química
Comércio
Rotulagem de Medicamentos
Internet
Substâncias para Melhoria do Desempenho/química
Receptores Androgênicos
[Mh] Termos MeSH secundário: Acetamidas/análise
Aminofenóis/análise
Anilidas/análise
Aprovação de Drogas
Tráfico de Drogas
Nitrilos/análise
Pirrolidinas/análise
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE; RESEARCH SUPPORT, N.I.H., EXTRAMURAL
[Nm] Nome de substância:
0 (4-(2-(2,2,2-trifluoro-1-hydroxyethyl)pyrrolidin-1-yl)-2-(trifluoromethyl)benzonitrile); 0 (Acetamides); 0 (Aminophenols); 0 (Anabolic Agents); 0 (Anilides); 0 (Nitriles); 0 (Performance-Enhancing Substances); 0 (Pyrrolidines); 0 (Receptors, Androgen); 7UT2HAH49H (andarine); O3571H3R8N (ostarine)
[Em] Mês de entrada:1712
[Cu] Atualização por classe:180228
[Lr] Data última revisão:
180228
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:171129
[St] Status:MEDLINE
[do] DOI:10.1001/jama.2017.17069


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[PMID]:29320302
[Au] Autor:Joffe S; Lynch HF
[Ad] Endereço:From the Department of Medical Ethics and Health Policy, Perelman School of Medicine, and the Leonard Davis Institute of Health Economics, University of Pennsylvania (S.J., H.F.L.), and the Children's Hospital of Philadelphia (S.J.) - all in Philadelphia.
[Ti] Título:Federal Right-to-Try Legislation - Threatening the FDA's Public Health Mission.
[So] Source:N Engl J Med;378(8):695-697, 2018 Feb 22.
[Is] ISSN:1533-4406
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Drogas/legislação & jurisprudência
Drogas em Investigação
Regulamentação Governamental
Acesso aos Serviços de Saúde/legislação & jurisprudência
Legislação de Medicamentos
Segurança do Paciente/legislação & jurisprudência
United States Food and Drug Administration/legislação & jurisprudência
[Mh] Termos MeSH secundário: Ensaios Clínicos Fase I como Assunto
Estado Terminal
Avaliação de Medicamentos/legislação & jurisprudência
Indústria Farmacêutica/legislação & jurisprudência
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos
Seres Humanos
Responsabilidade Legal
Estados Unidos
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (Drugs, Investigational)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180226
[Lr] Data última revisão:
180226
[Sb] Subgrupo de revista:AIM; IM
[Da] Data de entrada para processamento:180111
[St] Status:MEDLINE
[do] DOI:10.1056/NEJMp1714054


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[PMID]:29324623
[Au] Autor:Hussar DA
[Ad] Endereço:Remington Professor of Pharmacy Philadelphia College of Pharmacy University of the Sciences Philadelphia, Pa.
[Ti] Título:New Drugs 2018, part 1.
[So] Source:Nursing;48(2):36-44, 2018 Feb.
[Is] ISSN:1538-8689
[Cp] País de publicação:United States
[La] Idioma:eng
[Mh] Termos MeSH primário: Aprovação de Drogas
[Mh] Termos MeSH secundário: Anticorpos Monoclonais/uso terapêutico
Anticorpos Neutralizantes/uso terapêutico
Antipirina/análogos & derivados
Antipirina/uso terapêutico
Benzamidas/uso terapêutico
Benzimidazóis/uso terapêutico
Carbamatos/uso terapêutico
Combinação de Medicamentos
Compostos Heterocíclicos de 4 ou mais Anéis/uso terapêutico
Seres Humanos
Compostos Macrocíclicos/uso terapêutico
Naltrexona/análogos & derivados
Naltrexona/uso terapêutico
Peptídeos Natriuréticos/uso terapêutico
Piridinas/uso terapêutico
Quinoxalinas/uso terapêutico
Sofosbuvir/uso terapêutico
Sulfonamidas/uso terapêutico
Estados Unidos
United States Food and Drug Administration
[Pt] Tipo de publicação:JOURNAL ARTICLE
[Nm] Nome de substância:
0 (ABT-493); 0 (Antibodies, Monoclonal); 0 (Antibodies, Neutralizing); 0 (Benzamides); 0 (Benzimidazoles); 0 (Carbamates); 0 (Drug Combinations); 0 (Heterocyclic Compounds, 4 or More Rings); 0 (Macrocyclic Compounds); 0 (Natriuretic Peptides); 0 (Pyridines); 0 (Quinoxalines); 0 (Sulfonamides); 0 (bezlotoxumab); 0 (naldemedine); 0 (pibrentasvir); 0 (voxilaprevir); 5S6W795CQM (Naltrexone); 74RWP7W0J9 (betrixaban); 7IK8Z952OK (plecanatide); KCU0C7RS7Z (velpatasvir); S798V6YJRP (phenylmethylpyrazolone); T3CHA1B51H (Antipyrine); WJ6CA3ZU8B (Sofosbuvir)
[Em] Mês de entrada:1802
[Cu] Atualização por classe:180223
[Lr] Data última revisão:
180223
[Sb] Subgrupo de revista:N
[Da] Data de entrada para processamento:180112
[St] Status:MEDLINE
[do] DOI:10.1097/01.NURSE.0000529803.83288.e1



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