COMPARISON OF APPROVAL DATES OF NEW SUBSTANCES BETWEEN THE UNITED STATES OF AMERICA (FOOD AND DRUG ADMINISTRATION, FDA) AND EUROPE (EUROPEAN MEDICINES AGENCY, EMA)

被引：0
|
作者：
Batscheider, A. [1 ]
Weiss, K. [2 ]
Schnauffer, D. [3 ]
Al-Khalaf, A. [3 ]
Greiner, R. A. [3 ]
Shlaen, E. [3 ]
机构：
[1] IQVIA Commercial GmbH & Co OHG, Munich, BY, Germany
[2] IQVIA Commercial GmbH & Co OHG, Munich, Bavaria, Germany
[3] IQVIA Commercial GmbH & Co OHG, Munich, Germany
来源：
VALUE IN HEALTH | 2023年 / 26卷 / 12期
关键词：
D O I：
暂无
中图分类号：
F [经济];
学科分类号：
02 ;
摘要：
PT25
引用
收藏
页码：S293 / S293
页数：1
相关论文
共 48 条
  • [31] Comparison of COVID-19 Vaccine Approvals at the US Food and Drug Administration, European Medicines Agency, and Health Canada
    Lythgoe, Mark P.
    Middleton, Paul
    JAMA NETWORK OPEN, 2021, 4 (06)
  • [32] Real-world outcomes associated with new cancer medicines approved by the Food and Drug Administration and European Medicines Agency: A retrospective cohort study
    Boyle, Jemma M.
    Hegarty, Gemma
    Frampton, Christopher
    Harvey-Jones, Elizabeth
    Dodkins, Joanna
    Beyer, Katharina
    George, Gincy
    Sullivan, Richard
    Booth, Christopher
    Aggarwal, Ajay
    EUROPEAN JOURNAL OF CANCER, 2021, 155 : 136 - 144
  • [33] Registration by the European Agency for the Evaluation of Medicinal products (EMEA) of oncology products approved by the Food and Drug Administration (FDA) under accelerated approval (AA) regulations.
    Talarico, L
    Pignatti, F
    Pazdur, R
    JOURNAL OF CLINICAL ONCOLOGY, 2005, 23 (16) : 541S - 541S
  • [34] To what degree are review outcomes aligned for new active substances (NASs) between the European Medicines Agency and the US Food and Drug Administration? A comparison based on publicly available information for NASs initially approved in the time period 2014 to 2016
    Kuhler, Thomas Christian
    Bujar, Magda
    McAuslane, Neil
    Liberti, Lawrence
    BMJ OPEN, 2019, 9 (11):
  • [35] Are finasteride-related penile curvature/Peyronie’s disease Adverse Event Reports worthy of further clinical investigation? Disproportionality analysis based on both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) pharmacovigilance databases
    Nicolò Schifano
    Paolo Capogrosso
    Luca Boeri
    Giuseppe Fallara
    Stefania Chiappini
    Matthew Rewhorn
    Omer Onur Cakir
    Hannah Harvey
    Fabio Castiglione
    Hussain M. Alnajjar
    Asif Muneer
    Federico Deho’
    Fabrizio Schifano
    Francesco Montorsi
    Andrea Salonia
    International Journal of Impotence Research, 2023, 35 : 465 - 471
  • [36] Multifocal and Extended Depth of Focus Intraocular Lenses: A Comparison of Data from the United States Food and Drug Administration Premarket Approval Trials
    Schallhorn, Julie M.
    JOURNAL OF REFRACTIVE SURGERY, 2021, 37 (02) : 98 - +
  • [37] Are finasteride-related penile curvature/Peyronie's disease Adverse Event Reports worthy of further clinical investigation? Disproportionality analysis based on both the Food and Drug Administration (FDA) and the European Medicines Agency (EMA) pharmacovigilance databases
    Schifano, Nicolo
    Capogrosso, Paolo
    Boeri, Luca
    Fallara, Giuseppe
    Chiappini, Stefania
    Rewhorn, Matthew
    Cakir, Omer Onur
    Harvey, Hannah
    Castiglione, Fabio
    Alnajjar, Hussain M.
    Muneer, Asif
    Deho', Federico
    Schifano, Fabrizio
    Montorsi, Francesco
    Salonia, Andrea
    INTERNATIONAL JOURNAL OF IMPOTENCE RESEARCH, 2023, 35 (05) : 465 - 471
  • [38] A review of bridging clinical studies between different presentations of biological products approved by the United States Food and Drug Administration (US FDA)
    Patel, Ronak
    Ghadge, Pravin
    Nair, Pravin A.
    Kumar, Manish
    Adhikary, Laxmi
    EXPERT OPINION ON BIOLOGICAL THERAPY, 2022, 22 (10) : 1293 - 1310
  • [39] SmartTots: a public-private partnership between the United States Food and Drug Administration (FDA) and the International Anesthesia Research Society (IARS)
    Ramsay, James G.
    Roizen, Michael
    PEDIATRIC ANESTHESIA, 2012, 22 (10) : 969 - 972
  • [40] Real-World Evidence (RWE) Studies Supported Hematologic Oncology United States Food and Drug Administration (US FDA) Approval: What Do They Look like?
    Yue, Binglin
    Greenbaum, Adam
    Sun, Shaohui
    Zhu, Enda
    Weng, Shicheng
    Du, Chenmu
    Zhang, Xiaojuan
    Liao, Shanmei
    BLOOD, 2022, 140 : 13208 - 13209
12345