Analysis of post-marketing requirements for oncology drug conditional approvals in the United States and China

被引:0
|
作者
Ge, Chenghao [1 ]
An, Jing [1 ,2 ]
Chen, Xiaoyuan [1 ,3 ]
机构
[1] Tsinghua Univ, Tsinghua Med, Tsinghua Clin Res Inst, Beijing, Peoples R China
[2] R&G PharmaStudies Co Ltd, Beijing, Peoples R China
[3] Beijing Tsinghua Changgung Hosp, Off Clin Trial Inst, Beijing, Peoples R China
关键词
ACCELERATED APPROVAL;
D O I
10.1016/j.heliyon.2024.e35454
中图分类号
O [数理科学和化学]; P [天文学、地球科学]; Q [生物科学]; N [自然科学总论];
学科分类号
07 ; 0710 ; 09 ;
摘要
引用
收藏
页数:9
相关论文
共 50 条
  • [1] Post-marketing Surveillance of Methadone and Buprenorphine in the United States
    Dasgupta, Nabarun
    Bailey, Elise J.
    Cicero, Theodore
    Inciardi, James
    Parrino, Mark
    Rosenblum, Andrew
    Dart, Richard C.
    PAIN MEDICINE, 2010, 11 (07) : 1078 - 1091
  • [2] Variation in oncology drug approvals in Canada, the United States and Europe
    Khan, O. F.
    Samuel, N. N.
    Verma, S.
    ANNALS OF ONCOLOGY, 2018, 29
  • [3] POST-MARKETING SURVEILLANCE OF APPROVED PHARMACEUTICALS IN THE UNITED-STATES
    NICHOL, FR
    PICKERING, BI
    BOLLERT, JA
    CONTROLLED CLINICAL TRIALS, 1980, 1 (02): : 178 - 178
  • [4] POST-MARKETING DRUG SURVEILLANCE
    WALDEN, RJ
    PRICHARD, BNC
    BRITISH JOURNAL OF CLINICAL PHARMACOLOGY, 1978, 6 (03) : 191 - 192
  • [5] Clinical Trial Diversity in Oncology: FDA Takes Action with Post-Marketing Requirements or Commitments
    Kim, Janice
    Kester, Robert
    Blumenthal, Gideon
    ONCOLOGIST, 2022, 27 (12): : 993 - 997
  • [6] Development of the Post-Marketing Requirements (PMR) Database
    Mouchet, Julie
    Albrieux, Marine
    Maier, Will
    PHARMACOEPIDEMIOLOGY AND DRUG SAFETY, 2012, 21 : 218 - 218
  • [7] DEVELOPMENT OF A POST-MARKETING REQUIREMENTS (PMR) DATABASE
    Mouchet, J.
    Emery, M. P.
    Maier, W.
    VALUE IN HEALTH, 2012, 15 (07) : A465 - A465
  • [8] POST-MARKETING SURVEILLANCE BY DRUG MANUFACTURERS
    不详
    LANCET, 1988, 2 (8617): : 977 - 977
  • [9] Post-Marketing Drug Withdrawals: A Review
    Nutan Rao
    Roshani Powar
    Pharmaceutical Chemistry Journal, 2023, 57 : 1138 - 1146
  • [10] POST-MARKETING SURVEILLANCE - DRUG EPIDEMIOLOGY
    BORDEN, EK
    JOURNAL OF INTERNATIONAL MEDICAL RESEARCH, 1981, 9 (06) : 401 - 407