Cargando…

Assessing the potential clinical impact of reciprocal drug approval legislation on access to novel therapeutics in the USA: a cohort study

OBJECTIVE: To quantify the potential effect of reciprocal approval legislation on access to clinically impactful therapeutics in the USA. DESIGN: A cohort study. SETTING: New therapeutics approved by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and/or Health Canada between...

Descripción completa

Detalles Bibliográficos
Autores principales:	Larochelle, Matthieu, Downing, Nicholas S, Ross, Joseph S, David, Frank S
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group 2017
Materias:	Health Policy
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5306516/ https://www.ncbi.nlm.nih.gov/pubmed/28179418 http://dx.doi.org/10.1136/bmjopen-2016-014582

Ejemplares similares

Drug approval status and recommendations for listing on public formularies: a Canadian cohort analysis
por: Lexchin, Joel
Publicado: (2017)

Perspectives on Spain’s legislative experience providing access to healthcare to irregular migrants: a qualitative interview study
por: Hsia, Renee Y, et al.
Publicado: (2021)

Time to market for drugs approved in Canada between 2014 and 2018: an observational study
por: Lexchin, Joel
Publicado: (2021)

Quality of evidence considered by Health Canada in granting full market authorisation to new drugs with a conditional approval: a retrospective cohort study
por: Lexchin, Joel
Publicado: (2018)

Comparison of novel oncology drugs that received dual approval from the US accelerated approval and EU conditional marketing authorisation pathways, 2006–2021: a cross-sectional study
por: Xie, Jinping, et al.
Publicado: (2023)

Association of expedited review programmes with postmarketing safety events of new drugs approved by the US food and drug administration between 2007 and 2017
por: Zhu, Xingyue, et al.
Publicado: (2022)

Legislative landscape for traditional health practitioners in Southern African development community countries: a scoping review
por: Abrams, Amber Louise, et al.
Publicado: (2020)

Application of orphan drug designation to cancer treatments (2008–2017): a comprehensive and comparative analysis of the USA and EU
por: Vokinger, Kerstin Noëlle, et al.
Publicado: (2019)

The rights and interests of First Nations, Métis, and Inuit in debates over deemed consent legislation for deceased organ donation in Canada: calls to action
por: Tait, Caroline L.
Publicado: (2023)

Postmarket safety in Canada: are significant therapeutic advances and biologics less safe than other drugs? A cohort study
por: Lexchin, Joel
Publicado: (2014)

From the international tobacco control arena to the local context: a qualitative study on the tobacco advertising, promotion and sponsorship legislative environment in Sudan and the challenges characterising it
por: Tselengidis, Arsenios, et al.
Publicado: (2023)

Quality of advertisements for prescription drugs in family practice medical journals published in Australia, Canada and the USA with different regulatory controls: a cross-sectional study
por: Diep, Dion, et al.
Publicado: (2020)

Opioid‐limiting legislation and prescribing habits of otolaryngologists among Medicare beneficiaries
por: Kim, Yun Ji, et al.
Publicado: (2023)

A New Approach to Psychiatric Drug Approval in Europe
por: Barbui, Corrado, et al.
Publicado: (2013)

Expanding access to high-cost medicines through the E2 access program in Thailand: effects on utilisation, health outcomes and cost using an interrupted time-series analysis
por: Sruamsiri, Rosarin, et al.
Publicado: (2016)

United States Congressional COVID-19 Legislation: Recent Laws and Future Topics
por: Dowling, Marisa K., et al.
Publicado: (2020)

Characteristics of paid malpractice claims settled in and out of court in the USA: a retrospective analysis
por: Rubin, Jessica B, et al.
Publicado: (2013)

Is there variation in private payor payments to cancer surgeons? A cross-sectional study in the USA
por: Bongiovanni, Tasce, et al.
Publicado: (2020)

Estimation of Value-Based Price for Five High-Technology Medical Devices Approved by a Regional Health Technology Assessment Committee in Italy
por: Messori, Andrea, et al.
Publicado: (2022)

Accessibility and quality of drug company disclosures of payments to healthcare professionals and organisations in 37 countries: a European policy review
por: Ozieranski, Piotr, et al.
Publicado: (2021)

Measuring concordance of data sources used for infectious disease research in the USA: a retrospective data analysis
por: Majumder, Maimuna S, et al.
Publicado: (2023)

Can antipoverty programmes save lives? Quasi-experimental evidence from the Earned Income Tax Credit in the USA
por: Muennig, Peter, et al.
Publicado: (2020)

Promoting COVID-19 vaccine acceptance: recommendations from the Lancet Commission on Vaccine Refusal, Acceptance, and Demand in the USA
por: Omer, Saad B, et al.
Publicado: (2021)

Identifying high-value care for Medicare beneficiaries: a cross-sectional study of acute care hospitals in the USA
por: Herrin, Jeph, et al.
Publicado: (2022)

Development and validation of the age-associated dementia policy (AgeD-Pol) computer simulation model in the USA and Europe
por: Hyle, Emily P, et al.
Publicado: (2022)

Best practices for community-engaged participatory research with Pacific Islander communities in the USA and USAPI: protocol for a scoping review
por: McElfish, Pearl Anna, et al.
Publicado: (2018)

Governing the Access to COVID-19 Tools Accelerator: towards greater participation, transparency, and accountability
por: Moon, Suerie, et al.
Publicado: (2022)

Policy changes and the screening, diagnosis and treatment of drug-resistant tuberculosis patients from 2015 to 2018 in Zhejiang Province, China: a retrospective cohort study
por: Jiang, Weixi, et al.
Publicado: (2021)

Market competition among manufacturers of novel high-risk therapeutic devices receiving FDA premarket approval between 2001 and 2018
por: Rathi, Vinay K, et al.
Publicado: (2023)

Legislating for public accountability in universal health coverage, Thailand
por: Kantamaturapoj, Kanang, et al.
Publicado: (2020)

Evaluating the impacts of screening and smoking cessation programmes on lung cancer in a high-burden region of the USA: a simulation modelling study
por: Tramontano, Angela C, et al.
Publicado: (2016)

Association of patient engagement strategies with utilisation and spending for musculoskeletal problems in the USA: a cross-sectional analysis of Medicare patients and physician practices
por: Brown, Timothy T, et al.
Publicado: (2021)

Trends and geographical variation in population thriving, struggling and suffering across the USA, 2008–2017: a retrospective repeated cross-sectional study
por: Riley, Carley, et al.
Publicado: (2021)

Disparities in access to cancer diagnostics in ASEAN member countries
por: Alberto, Nicole Rose I., et al.
Publicado: (2023)

New model of integrated care for uncontrolled type 2 diabetes in a retrospective, underserved adult population in the USA: a study protocol for an effectiveness and cost-effectiveness analysis
por: Bosetti, Rita, et al.
Publicado: (2020)

‘The burden of wanting to make it right’: thematic analysis of semistructured interviews to explore experiences of planning for crisis standards of care and ventilator allocation during the COVID-19 pandemic in the USA
por: MacMartin, Meredith, et al.
Publicado: (2023)

Assessment of Clinical Trials Supporting US Food and Drug Administration Approval of Novel Therapeutic Agents, 1995-2017
por: Zhang, Audrey D., et al.
Publicado: (2020)

A qualitative evaluation of general practitioners' perceptions regarding access to medicines in New Zealand
por: Babar, Zaheer-Ud-Din, et al.
Publicado: (2012)

Challenges in ensuring global access to COVID-19 vaccines: production, affordability, allocation, and deployment
por: Wouters, Olivier J, et al.
Publicado: (2021)

Mixing age and risk groups for accessing COVID-19 vaccines: a modelling study
por: Wang, Hongming, et al.
Publicado: (2022)

Cannot write session to /tmp/vufind_sessions/sess_1d42dskb4phv16vqp0o5bo72hq