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
  • [21] Use of real-world evidence for healthcare decision-making in the Middle East: practical considerations and future directions
    Akhras, Kasem S.
    Alsheikh-Ali, Alawi A.
    Kabbani, Samer
    EXPERT REVIEW OF PHARMACOECONOMICS & OUTCOMES RESEARCH, 2019, 19 (03) : 245 - 250
  • [22] Nonrandomized Real-World Evidence to Support Regulatory Decision Making: Process for a Randomized Trial Replication Project
    Franklin, Jessica M.
    Pawar, Ajinkya
    Martin, David
    Glynn, Robert J.
    Levenson, Mark
    Temple, Robert
    Schneeweiss, Sebastian
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2020, 107 (04) : 817 - 826
  • [23] Best Evidence to Support Regulatory Decision-Making
    Blake, K.
    Fitt, H.
    Hidalgo-Simon, A.
    Arlett, P.
    DRUG SAFETY, 2013, 36 (09) : 866 - 866
  • [24] Real-World Evidence to Support EU Regulatory Decision Making-Results From a Pilot of Regulatory Use Cases
    Prilla, Stefanie
    Groeneveld, Sophie
    Pacurariu, Alexandra
    Restrepo-Mendez, Maria Clara
    Verpillat, Patrice
    Torre, Carla
    Gartner, Christian
    Mol, Peter G. M.
    Naumann-Winter, Frauke
    Breen, Kieran C.
    Gault, Nathalie
    Gross-Martirosyan, Liana
    Benchetrit, Sylvie
    Aylward, Brian
    Stoyanova-Beninska, Violeta
    O'Donovan, Maura
    Straus, Sabine
    Kjaer, Jesper
    Arlett, Peter
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2024,
  • [25] Smog, Cognition and Real-World Decision-Making
    Chen, Xi
    INTERNATIONAL JOURNAL OF HEALTH POLICY AND MANAGEMENT, 2019, 8 (02): : 76 - 80
  • [26] EXAMINE THE USE OF REAL-WORLD EVIDENCE TO SUPPORT FDA DECISION-MAKING FOR NEW DRUG APPLICATIONS AND BIOLOGICS LICENSE APPLICATIONS FROM 2021 TO 2022
    Cheng, C. H.
    Farley, J. F.
    VALUE IN HEALTH, 2024, 27 (06) : S216 - S216
  • [27] USING REAL-WORLD EVIDENCE TO SUPPORT REIMBURSEMENT DECISION-MAKING IN CHINA: CURRENT PRACTICES, CHALLENGES AND OPPORTUNITIES
    Liu, J.
    Feng, Y.
    Yang, S.
    Yin, Z.
    Xie, Y.
    VALUE IN HEALTH, 2023, 26 (06) : S141 - S141
  • [28] Real-world evidence enhances decision making
    Malone, Daniel C.
    JOURNAL OF MANAGED CARE & SPECIALTY PHARMACY, 2020, 26 (12): : 1612 - 1614
  • [29] Support vector machine with fuzzy decision-making for real-world data classification
    Li, Boyang
    Hu, Jinglu
    Hirasawa, Kotaro
    Sun, Pu
    Marko, Kenneth
    2006 IEEE INTERNATIONAL JOINT CONFERENCE ON NEURAL NETWORK PROCEEDINGS, VOLS 1-10, 2006, : 587 - +
  • [30] Leveraging Real-World Evidence Derived from Patient Registries for Premarket Medical Device Regulatory Decision-Making
    Yue, Lilly Q.
    STATISTICS IN BIOPHARMACEUTICAL RESEARCH, 2018, 10 (02): : 98 - 103
12345