KEY CONSIDERATIONS FOR EVALUATING REAL-WORLD EVIDENCE IN SUPPORT OF FDA REGULATORY DECISION-MAKING

被引：0
|
作者：
Li, Jie [1 ]
机构：
[1] FDA CDER Off Surveillance & Epidemiol, Silver Spring, MD USA
来源：
INNOVATION IN AGING | 2022年 / 6卷
关键词：
D O I：
暂无
中图分类号：
R592 [老年病学]; C [社会科学总论];
学科分类号：
03 ; 0303 ; 100203 ;
摘要：
引用
收藏
页码：193 / 193
页数：1
相关论文
共 50 条
  • [1] Real-world evidence to support regulatory decision-making for medicines: Considerations for external control arms
    Burcu, Mehmet
    Dreyer, Nancy A.
    Franklin, Jessica M.
    Blum, Michael D.
    Critchlow, Cathy W.
    Perfetto, Eleanor M.
    Zhou, Wei
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2020, 29 (10) : 1228 - 1235
  • [2] Real-world endpoints to support regulatory decision-making
    Christian, Jennifer B.
    Warren, Edward J.
    Cameron, David
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2020, 29 : 427 - 427
  • [3] The application of real-world evidence in drug regulatory decision-making
    Wicherski, Julia
    Haenisch, Britta
    BUNDESGESUNDHEITSBLATT-GESUNDHEITSFORSCHUNG-GESUNDHEITSSCHUTZ, 2024, 67 (02) : 255 - 256
  • [4] USING REAL-WORLD EVIDENCE TO SUPPORT THE FDA REGULATORY APPROVAL: METHODOLOGICAL CONSIDERATIONS
    Lu, Kevin
    Slattum, Patricia
    INNOVATION IN AGING, 2022, 6 : 193 - 193
  • [5] Comparison of two assessments of real-world data and real-world evidence for regulatory decision-making
    Yuan, Lily
    Rahman, Motiur
    Concato, John
    CTS-CLINICAL AND TRANSLATIONAL SCIENCE, 2024, 17 (01):
  • [6] 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
  • [7] SUITABILITY OF NORDIC REAL-WORLD DATA TO SUPPORT US REGULATORY DECISION-MAKING
    Geale, K.
    Grip, Toresson E.
    Ortsater, G.
    VALUE IN HEALTH, 2022, 25 (12) : S255 - S255
  • [8] 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
  • [9] Development of audit readiness considerations of real-world data for use in regulatory decision-making
    Atzinger, Christopher B.
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2023, 32 : 411 - 411
  • [10] Multidimensional Evidence Generation and FDA Regulatory Decision Making Defining and Using "Real-World" Data
    Jarow, Jonathan P.
    LaVange, Lisa
    Woodcock, Janet
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 318 (08): : 703 - 704
12345