Cargando…

Therapeutic value of first versus supplemental indications of drugs in US and Europe (2011-20): retrospective cohort study

OBJECTIVE: To analyze the therapeutic value of supplemental indications compared with first indications for drugs approved in the US and Europe. DESIGN: Retrospective cohort study. SETTING: New and supplemental indications approved by the US Food and Drug Administration (FDA) and European Medicines...

Descripción completa

Detalles Bibliográficos
Autores principales:	Vokinger, Kerstin N, Glaus, Camille E G, Kesselheim, Aaron S, Serra-Burriel, Miquel, Ross, Joseph S, Hwang, Thomas J
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	BMJ Publishing Group Ltd. 2023
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10320829/ https://www.ncbi.nlm.nih.gov/pubmed/37407074 http://dx.doi.org/10.1136/bmj-2022-074166

Ejemplares similares

Therapeutic Value Assessments of Novel Medicines in the US and Europe, 2018-2019
por: Vokinger, Kerstin N., et al.
Publicado: (2022)

Therapeutic Value of Drugs Granted Accelerated Approval or Conditional Marketing Authorization in the US and Europe From 2007 to 2021
por: Vokinger, Kerstin N., et al.
Publicado: (2022)

The cancer premium – explaining differences in prices for cancer vs non-cancer drugs with efficacy and epidemiological endpoints in the US, Germany, and Switzerland: a cross sectional study
por: Serra-Burriel, Miquel, et al.
Publicado: (2023)

Association between FDA and EMA expedited approval programs and therapeutic value of new medicines: retrospective cohort study
por: Hwang, Thomas J, et al.
Publicado: (2020)

Comparison of Uptake and Prices of Biosimilars in the US, Germany, and Switzerland
por: Carl, David L., et al.
Publicado: (2022)

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)

Mitigating bias in machine learning for medicine
por: Vokinger, Kerstin N., et al.
Publicado: (2021)

Clinical Benefit and Expedited Approval of Cancer Drugs in the United States, European Union, Switzerland, Japan, Canada, and Australia
por: Hwang, Thomas J., et al.
Publicado: (2022)

Patients’ access to drugs with rebates in Switzerland – Empirical analysis and policy implications for drug pricing in Europe
por: Carl, David L, et al.
Publicado: (2021)

Characteristics of efficacy evidence supporting approval of supplemental indications for prescription drugs in United States, 2005-14: systematic review
por: Wang, Bo, et al.
Publicado: (2015)

Novel Orthobunyavirus in Cattle, Europe, 2011
por: Hoffmann, Bernd, et al.
Publicado: (2012)

Characteristics of Recent Generic Drug Approvals by the US Food and Drug Administration
por: Jiao, Kuo, et al.
Publicado: (2019)

Association of Advisory Committee Votes With US Food and Drug Administration Decision-Making on Prescription Drugs, 2010-2021
por: Daval, C. Joseph Ross, et al.
Publicado: (2023)

Use of Extrapolation in New Drug Approvals by the US Food and Drug Administration
por: Feldman, Daniel, et al.
Publicado: (2022)

Spending on World Health Organization essential medicines in Medicare Part D, 2011-15: retrospective cost analysis
por: Li, David G, et al.
Publicado: (2019)

Predictive modeling of emergency cesarean delivery
por: Campillo-Artero, Carlos, et al.
Publicado: (2018)

Legionnaires’ disease in Europe, 2011 to 2015
por: Beauté, Julien
Publicado: (2017)

Therapeutic Value of Drugs Frequently Marketed Using Direct-to-Consumer Television Advertising, 2015 to 2021
por: Patel, Neeraj G., et al.
Publicado: (2023)

Characteristics of US Patients and Prescribers Using Hydroxychloroquine During the COVID-19 Pandemic
por: Rome, Benjamin N., et al.
Publicado: (2021)

Hematopoietic SCT in Europe: data and trends in 2011
por: Passweg, J R, et al.
Publicado: (2013)

Multidrug-Resistant Tuberculosis in Europe, 2010–2011
por: Günther, Gunar, et al.
Publicado: (2015)

US Food and Drug Administration Review Time of Supplemental New Indication Approvals of Drugs and Biologics, 2017 to 2019
por: Dhodapkar, Meera M., et al.
Publicado: (2023)

Postmarket Surveillance of Medical Devices: A Comparison of Strategies in the US, EU, Japan, and China
por: Kramer, Daniel B., et al.
Publicado: (2013)

Supplement 2 September 2011
Publicado: (2011)

Lenience breeds strictness: The generosity-erosion effect in hiring decisions
por: Vives, Marc-Lluís, et al.
Publicado: (2021)

Characteristics of Postmarketing Studies for Vaccines Approved by the US Food and Drug Administration, 2006-2020
por: Moneer, Osman, et al.
Publicado: (2021)

Lost in Anonymization — A Data Anonymization Reference Classification Merging Legal and Technical Considerations
por: Vokinger, Kerstin N., et al.
Publicado: (2020)

National society cardiovascular journals of Europe: Almanac 2011
por: Timmis, A D, et al.
Publicado: (2011)

National Society Cardiovascular Journals of Europe: Almanac 2011
por: Timmis, Adam D., et al.
Publicado: (2011)

Safety related label changes for new drugs after approval in the US through expedited regulatory pathways: retrospective cohort study
por: Mostaghim, Sana R, et al.
Publicado: (2017)

Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval
por: Cherla, Avi, et al.
Publicado: (2021)

The Challenges of Inflation in Europe and the US
Publicado: (2022)

Cost‐Sharing Increase, Medication Adherence, and Hospitalizations in Schizophrenia Patients: A Natural Experiment
por: Serra‐Burriel, Miquel, et al.
Publicado: (2021)

Dietary Supplement Use Differs by Socioeconomic and Health-Related Characteristics among U.S. Adults, NHANES 2011–2014
por: Cowan, Alexandra E., et al.
Publicado: (2018)

Characteristics of Clinical Studies Used for US Food and Drug Administration Supplemental Indication Approvals of Drugs and Biologics, 2017 to 2019
por: Dhodapkar, Meera, et al.
Publicado: (2021)

Factors and Situations Affecting the Value of Patient Preference Studies: Semi-Structured Interviews in Europe and the US
por: Whichello, Chiara, et al.
Publicado: (2019)

ISSE 2011 securing electronic business processes: highlights of the information security solutions Europe 2011 conference
por: Pohlmann, Norbert, et al.
Publicado: (2011)

Acrylamide concentrations in potato crisps in Europe from 2002 to 2011
por: Powers, Stephen J., et al.
Publicado: (2013)

CERN Bulletin Issue No. 19-20/2011
Publicado: (2011)

Repurposing existing drugs for new uses: a cohort study of the frequency of FDA-granted new indication exclusivities since 1997
por: Sahragardjoonegani, Babak, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_09d6ghdml5ddn88k776olk3i6a