EXAMINE THE USE OF REAL-WORLD EVIDENCE TO SUPPORT FDA DECISION-MAKING FOR NEW DRUG APPLICATIONS AND BIOLOGICS LICENSE APPLICATIONS FROM 2021 TO 2022

被引:0
|
作者
Cheng, C. H. [1 ]
Farley, J. F. [2 ]
机构
[1] Univ Minnesota, St Paul, MN 55108 USA
[2] Univ Minnesota, Minneapolis, MN USA
关键词
D O I
暂无
中图分类号
F [经济];
学科分类号
02 ;
摘要
HPR127
引用
收藏
页码:S216 / S216
页数:1
相关论文
共 39 条
  • [1] The Role of Real-World Evidence in FDA-Approved New Drug and Biologics License Applications
    Purpura, Christina A.
    Garry, Elizabeth M.
    Honig, Nicholaas
    Case, Abigail
    Rassen, Jeremy A.
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2022, 111 (01) : 135 - 144
  • [2] Use of Real-World Evidence in Neuroscience-Related New Drug and Biologics License Applications for Novel Therapeutics
    Bloomfield-Clagett, Bartholt
    Rahman, Motiur
    Smith, Kimberly
    Concato, John
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023, 114 (05) : 1002 - 1005
  • [3] KEY CONSIDERATIONS FOR EVALUATING REAL-WORLD EVIDENCE IN SUPPORT OF FDA REGULATORY DECISION-MAKING
    Li, Jie
    INNOVATION IN AGING, 2022, 6 : 193 - 193
  • [4] The New FDA Real-World Evidence Program to Support Development of Drugs and Biologics
    Klonoff, David C.
    JOURNAL OF DIABETES SCIENCE AND TECHNOLOGY, 2020, 14 (02): : 345 - 349
  • [5] Real-World Evidence for Regulatory Decision-Making: Guidance From Around the World
    Burns, Leah
    Le Roux, Nadege
    Kalesnik-Orszulak, Robert
    Christian, Jennifer
    Hukkelhoven, Mathias
    Rockhold, Frank
    O'Donnell, John
    CLINICAL THERAPEUTICS, 2022, 44 (03) : 420 - 437
  • [6] CONTEXT MATTERS - A TAXONOMY OF REAL-WORLD DATA AND EVIDENCE TO SUPPORT HTA DECISION-MAKING
    Murphy, L. A.
    Mestre-Ferrandiz, J.
    Sola-Morales, O.
    de Pouvourville, G.
    Cunningham, D.
    Corry, S.
    Akehurst, R.
    VALUE IN HEALTH, 2020, 23 : S622 - S622
  • [7] Real-world evidence for regulatory decision-making: updated guidance from around the world
    Burns, Leah
    Le Roux, Nadege
    Kalesnik-Orszulak, Robert
    Christian, Jennifer
    Dudinak, Jennifer
    Rockhold, Frank
    Khozin, Sean
    O'Donnell, John
    FRONTIERS IN MEDICINE, 2023, 10
  • [8] Use of Real-world Data for New Drug Applications and Line Extensions
    Bolislis, Winona R.
    Fay, Myriam
    Kuhler, Thomas C.
    CLINICAL THERAPEUTICS, 2020, 42 (05) : 926 - 938
  • [9] Real-World Evidence in Support of Oncology Product Registration: A Systematic Review of New Drug Application and Biologics License Application Approvals from 2015-2020
    Arondekar, Bhakti
    Duh, Mei Sheng
    Bhak, Rachel H.
    DerSarkissian, Maral
    Huynh, Lynn
    Wang, Kelsey
    Wojciehowski, John
    Wu, Melody
    Wornson, Bryon
    Niyazov, Alexander
    Demetri, George D.
    CLINICAL CANCER RESEARCH, 2022, 28 (01) : 27 - 35
  • [10] Expert survey on real-world data utilization and real-world evidence generation for regulatory decision-making in drug lifecycle in Korea
    Lee, Hankil
    Ahn, Hyeon-Soo
    Kwon, Sol
    Kang, Hye-Young
    Han, Euna
    CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2024, 17 (04):