Cargando…

Cystic Fibrosis Treatment: A Paradigm for New Pediatric Medicines, Globalization of Drug Development and the Role of the European Medicines Agency

The European Pediatric Pharmaceutical Legislation wants children to benefit more from pharmaceutical progress. In rare diseases, concerns have been raised that this legislation might damage research and stymie drug development. We discuss the role of the European Medicines Agency (EMA) and its Pedia...

Descripción completa

Detalles Bibliográficos
Autores principales:	Rose, Klaus, Spigarelli, Michael G.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	MDPI 2015
Materias:	Review
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4928746/ https://www.ncbi.nlm.nih.gov/pubmed/27417354 http://dx.doi.org/10.3390/children2010108

Ejemplares similares

The contributions of the European Medicines Agency and its pediatric committee to the fight against childhood leukemia
por: Rose, Klaus, et al.
Publicado: (2015)

The European Medicines Agency's approval of new medicines for type 2 diabetes
por: Blind, Eberhard, et al.
Publicado: (2018)

Comparison of hydroxyethyl starch regulatory summaries from the Food and Drug Administration and the European Medicines Agency
por: Wiedermann, Christian J., et al.
Publicado: (2017)

Psychopharmacology at the era of EMEA (European Medicines Agency)
por: Pestana, Luis Camara, et al.
Publicado: (2010)

A bacteriophage journey at the European Medicines Agency
por: Debarbieux, Laurent, et al.
Publicado: (2015)

The Iterative Development of Medicines Through the European Medicine Agency's Adaptive Pathway Approach
por: Nicotera, Giuseppe, et al.
Publicado: (2019)

New drug submissions in Canada and a comparison with the Food and Drug Administration and the European Medicines Agency: Cross-sectional analysis
por: Lexchin, Joel
Publicado: (2023)

Mobility endpoints in marketing authorisation of drugs: what gets the European medicines agency moving?
por: Jaeger, Simon U, et al.
Publicado: (2022)

Post‐Marketing Requirements for Cancer Drugs Approved by the European Medicines Agency, 2004–2014
por: Cherla, Avi, et al.
Publicado: (2022)

Stratified medicine in practice: review of predictive biomarkers in European Medicines Agency (EMA) indications
por: Malottki, Kinga, et al.
Publicado: (2011)

Stratified medicine in European Medicines Agency licensing: a systematic review of predictive biomarkers
por: Malottki, Kinga, et al.
Publicado: (2014)

Review: UK medicines likely to be affected by the proposed European Medicines Agency’s guidelines on phthalates
por: Jamieson, Lisa, et al.
Publicado: (2015)

Biomarker and Companion Diagnostics—A Review of Medicinal Products Approved by the European Medicines Agency
por: Orellana García, Laura Patricia, et al.
Publicado: (2021)

Overview of the European Medicines Agency's Experience With Biowaivers in Centralized Applications
por: Lenić, Ines, et al.
Publicado: (2019)

Real-world outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: A retrospective cohort study
por: Boyle, Jemma M., et al.
Publicado: (2021)

Evaluation of Companion Diagnostics in Scientific Advice and Drug Marketing Authorization Applications by the European Medicines Agency
por: Maliepaard, Marc, et al.
Publicado: (2022)

Patient-Reported Outcome Measures in Oncology Drugs Approved by the European Medicines Agency, 2017-2021
por: Ciani, Oriana, et al.
Publicado: (2023)

Associations between uncertainties identified by the European Medicines Agency and national decision making on reimbursement by HTA agencies
por: Bloem, Lourens T., et al.
Publicado: (2021)

Gene therapy for cystic fibrosis: new tools for precision medicine
por: Lee, Jin-A, et al.
Publicado: (2021)

Overview of the European Medicines Agency's Development of Product‐Specific Bioequivalence Guidelines
por: Sullivan, Jane O', et al.
Publicado: (2018)

Biomarker Qualification at the European Medicines Agency: A Look Under the Hood
por: Berman, Steven, et al.
Publicado: (2022)

Are the European Medicines Agency, US Food and Drug Administration, and Other International Regulators Talking to Each Other?
por: Teixeira, Tania, et al.
Publicado: (2019)

Using mechanistic models to support development of complex generic drug products: European Medicines Agency perspective
por: Manolis, Efthymios, et al.
Publicado: (2023)

Patient-reported outcome measures in drugs for neurological conditions approved by European Medicines Agency 2017–2022
por: Ciani, Oriana, et al.
Publicado: (2023)

European Medicinal Leeches—New Roles in Modern Medicine
por: Lemke, Sarah, et al.
Publicado: (2020)

Improving Risk Assessment in the European Food Safety Authority: Lessons From the European Medicines Agency
por: Chatzopoulou, Sevasti, et al.
Publicado: (2020)

European Medicines Agency Conflicts With the European Food Safety Authority (EFSA) on Bisphenol A Regulation
por: Zoeller, R Thomas, et al.
Publicado: (2023)

The evidence base for psychotropic drugs approved by the European Medicines Agency: a meta-assessment of all European Public Assessment Reports
por: Erhel, Florian, et al.
Publicado: (2020)

An Insight into Z-Drug Abuse and Dependence: An Examination of Reports to the European Medicines Agency Database of Suspected Adverse Drug Reactions
por: Schifano, Fabrizio, et al.
Publicado: (2019)

Personalized or Precision Medicine? The Example of Cystic Fibrosis
por: Marson, Fernando A. L., et al.
Publicado: (2017)

Access to regulatory data from the European Medicines Agency: the times they are a-changing
por: Wieseler, Beate, et al.
Publicado: (2012)

The European Medicines Agency’s scientific opinion on oral fexinidazole for human African trypanosomiasis
por: Pelfrene, Eric, et al.
Publicado: (2019)

Regulatory Science to 2025: An Analysis of Stakeholder Responses to the European Medicines Agency's Strategy
por: Hines, Philip A., et al.
Publicado: (2020)

Extension of the European Medicines Agency (EMA) approval of trifluridine/tipiracil for gastric cancer
por: Alsina, Maria, et al.
Publicado: (2019)

The European Medicines Agency's EU conditional marketing authorisations for COVID-19 vaccines
por: Cavaleri, Marco, et al.
Publicado: (2021)

Contribution of Real‐World Evidence in European Medicines Agency's Regulatory Decision Making
por: Bakker, Elisabeth, et al.
Publicado: (2022)

Shifting paradigms of nontuberculous mycobacteria in cystic fibrosis
por: Qvist, Tavs, et al.
Publicado: (2014)

Pharmacovigilance and the Italian Medicines Agency
por: Pimpinella, Giuseppe, et al.
Publicado: (2013)

European medicines agency guideline for biological medicinal products: a further step for a safe use of biosimilars
por: Agostini, Carlo, et al.
Publicado: (2015)

Availability and Affordability of Drugs With a Conditional Approval by the European Medicines Agency; Comparison of Korea With Other Countries and the Implications
por: Kwon, Hye-Young, et al.
Publicado: (2018)

Cannot write session to /tmp/vufind_sessions/sess_k4ht5eb74fv85fmoor4ob2ckok