Cargando…

A Comparison of EMA and FDA Decisions for New Drug Marketing Applications 2014–2016: Concordance, Discordance, and Why

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have robust scientific and technical collaborations. As a window to the impact of these activities we compared the agencies’ decisions on drug marketing applications. Decisions were compared for 107 new drug applications...

Descripción completa

Detalles Bibliográficos
Autores principales:	Kashoki, Mwango, Hanaizi, Zahra, Yordanova, Stella, Veselý, Richard, Bouygues, Christelle, Llinares, Jordi, Kweder, Sandra L.
Formato:	Online Artículo Texto
Lenguaje:	English
Publicado:	John Wiley and Sons Inc. 2019
Materias:	Research
Acceso en línea:	https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6977394/ https://www.ncbi.nlm.nih.gov/pubmed/31306483 http://dx.doi.org/10.1002/cpt.1565

Ejemplares similares

Considering Global Development? Insights from Applications for FDA Breakthrough Therapy and EMA PRIME Designations
por: Hanaizi, Zahra, et al.
Publicado: (2022)

EMA-FDA Parallel Scientific Advice: Optimizing Development of Medicines in the Global Age
por: Thor, Shannon, et al.
Publicado: (2023)

The Biosimilar Landscape: An Overview of Regulatory Approvals by the EMA and FDA
por: Gherghescu, Ioana, et al.
Publicado: (2020)

Regulatory approval of pharmaceuticals without a randomised controlled study: analysis of EMA and FDA approvals 1999–2014
por: Hatswell, Anthony J, et al.
Publicado: (2016)

A Disability Bioethics Reading of the FDA and EMA Evaluations on the Marketing Authorisation of Growth Hormone for Idiopathic Short Stature Children
por: Murano, Maria Cristina
Publicado: (2020)

Lutathera(®): The First FDA- and EMA-Approved Radiopharmaceutical for Peptide Receptor Radionuclide Therapy
por: Hennrich, Ute, et al.
Publicado: (2019)

Expanded Access as a source of real‐world data: An overview of FDA and EMA approvals
por: Polak, Tobias B., et al.
Publicado: (2020)

Overview of the Side-Effects of FDA- and/or EMA-Approved Targeted Therapies for the Treatment of Hematological Malignancies
por: Constantinescu, Catalin, et al.
Publicado: (2020)

FDA and EMA Approvals of New Breast Cancer Drugs—A Comparative Regulatory Analysis
por: Leo, Chandra P., et al.
Publicado: (2020)

First COVID-19 Vaccines Receiving the US FDA and EMA Emergency Use Authorization
por: Fortner, Andra, et al.
Publicado: (2021)

Elements of Regulatory Dissonance: Examining FDA and EMA Product Labeling of New Vaccines (2006–2018)
por: Seo, Yurim, et al.
Publicado: (2020)

Evaluation of the draft guidelines proposed by EMA and FDA for the clinical diagnosis of acute uncomplicated cystitis in women
por: Alidjanov, Jakhongir F., et al.
Publicado: (2019)

EMA and FDA psychiatric drug trial guidelines: assessment of guideline development and trial design recommendations
por: Boesen, Kim, et al.
Publicado: (2021)

Necessity of strengthening the current clinical regulatory for companion diagnostics: An institutional comparison of the FDA, EMA, and MFDS
por: Kang, Su Lim, et al.
Publicado: (2023)

Concordance and discordance of sequence survey methods for molecular epidemiology
por: Castro-Nallar, Eduardo, et al.
Publicado: (2015)

Measures for concordance and discordance with applications in disease control and prevention
por: Aerts, Marc, et al.
Publicado: (2018)

Sharing parental genomes by siblings concordant or discordant for autism
por: Wroten, Mathew, et al.
Publicado: (2023)

Scaffold Searching of FDA and EMA-Approved Drugs Identifies Lead Candidates for Drug Repurposing in Alzheimer’s Disease
por: Shityakov, Sergey, et al.
Publicado: (2021)

The impact of FDA and EMA regulatory decision-making process on the access to CFTR modulators for the treatment of cystic fibrosis
por: Costa, Enrico, et al.
Publicado: (2022)

Initial and supplementary indication approval of new targeted cancer drugs by the FDA, EMA, Health Canada, and TGA
por: Michaeli, Daniel Tobias, et al.
Publicado: (2022)

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)

A Critical Overview of FDA and EMA Statistical Methods to Compare In Vitro Drug Dissolution Profiles of Pharmaceutical Products
por: Muselík, Jan, et al.
Publicado: (2021)

Concordance and Discordance Between Brain Perfusion and Atrophy in Frontotemporal Dementia
por: Shimizu, Soichiro, et al.
Publicado: (2010)

Oral Microbiome: Streptococcus mutans/Caries Concordant-Discordant Children
por: Dinis, Márcia, et al.
Publicado: (2022)

Postmarketing studies for novel drugs approved by both the FDA and EMA between 2005 and 2010: a cross-sectional study
por: Zeitoun, Jean-David, et al.
Publicado: (2017)

Availability of Authorizations from EMA and FDA for Age-Appropriate Medicines Contained in the WHO Essential Medicines List for Children 2019
por: delMoral-Sanchez, Jose-Manuel, et al.
Publicado: (2020)

Process of drug registration in Israel: the correlation between the number of discussions within the Ministry of Health and postapproval variations by EMA and/or FDA
por: Hiayev, Stephany, et al.
Publicado: (2023)

Why Did the FDA Approve These Advertisements?
por: Oaks, David
Publicado: (2006)

Establishing chronic condition concordance and discordance with diabetes: a Delphi study
por: Magnan, Elizabeth M, et al.
Publicado: (2015)

Concordant and discordant DNA methylation signatures of aging in human blood and brain
por: Farré, Pau, et al.
Publicado: (2015)

Sociodemographic Correlates of HIV Discordant and Concordant Couples in Anambra State, Nigeria
por: Nnebue, Chinomnso, et al.
Publicado: (2017)

Detection of New Translocation in Infant Twins with Concordant ALL and Discordant Outcome
por: Bahoush, Golamreza, et al.
Publicado: (2020)

Echocardiographic parameters recommended for assessing the severity of tricuspid regurgitation: concordance and discordance
por: Wu, Yuanfeng, et al.
Publicado: (2023)

EMA : escala multidimensional de asertividad : manual /
por: Flores Galaz, Mirta Margarita
Publicado: (2004)

Concordant and Discordant Regulation of Target Genes by miR-31 and Its Isoforms
por: Chan, Yu-Tzu, et al.
Publicado: (2013)

Evaluating imaging-pathology concordance and discordance after ultrasound-guided breast biopsy
por: Park, Vivian Youngjean, et al.
Publicado: (2018)

Cerebrospinal fluid microglia and neurodegenerative markers in twins concordant and discordant for psychotic disorders
por: Johansson, Viktoria, et al.
Publicado: (2016)

Diagnostic concordance and discordance in digital pathology: a systematic review and meta-analysis
por: Azam, Ayesha S, et al.
Publicado: (2021)

Ema, la cautiva
por: Aira, César, 1949-

Entering First-in-Human Clinical Study With a Single-Strain Live Biotherapeutic Product: Input and Feedback Gained From the EMA and the FDA
por: Paquet, Jeanne-Céleste, et al.
Publicado: (2021)

Cannot write session to /tmp/vufind_sessions/sess_tnd1htlmhrdqpbdovgjpjjoq7a