Representativeness in Premarketing vs Postmarketing US Food and Drug Administration Trials

被引：1
|
作者：
Unger, Joseph M. [1 ]
机构：
[1] Fred Hutchinson Canc Res Ctr, 1100 Fairview Ave N,M3-C102,POB 19024, Seattle, WA 98109 USA
来源：
JAMA NETWORK OPEN | 2021年 / 4卷 / 04期
关键词：
D O I：
10.1001/jamanetworkopen.2021.7159
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
引用
收藏
页数：3
相关论文
共 50 条
  • [1] Power Morcellators, Postmarketing Surveillance, and the US Food and Drug Administration
    Redberg, Rita F.
    Jacoby, Alison F.
    Sharfstein, Joshua M.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2017, 318 (04): : 325 - 326
  • [2] US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018
    Skydel, Joshua J.
    Zhang, Audrey D.
    Dhruva, Sanket S.
    Ross, Joseph S.
    Wallach, Joshua D.
    CLINICAL TRIALS, 2021, 18 (04) : 488 - 499
  • [3] Postmarketing Safety of Vaccines Approved by the US Food and Drug Administration A Cohort Study
    Tau, Noam
    Yahav, Dafna
    Shepshelovich, Daniel
    ANNALS OF INTERNAL MEDICINE, 2020, 173 (06) : 445 - +
  • [4] Analysis of Postapproval Clinical Trials of Therapeutics Approved by the US Food and Drug Administration Without Clinical Postmarketing Requirements or Commitments
    Skydel, Joshua J.
    Luxkaranayagam, Anita T.
    Dhruva, Sanket S.
    Ross, Joseph S.
    Wallach, Joshua D.
    JAMA NETWORK OPEN, 2019, 2 (05)
  • [5] Adverse events of fluoxetine: Postmarketing compared with premarketing clinical trials
    Musa, MN
    Staneluis, JM
    JOURNAL OF CLINICAL PSYCHIATRY, 2000, 61 (11) : 874 - 874
  • [6] Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation
    Saito, Masami
    Iwasaki, Kiyotaka
    JOURNAL OF ARTIFICIAL ORGANS, 2017, 20 (01) : 62 - 70
  • [7] Analysis of the safety evaluation for premarketing clinical trials of hemodialyzer and of postmarketing safety reports of hemodialyzer in Japan and the US: insights into the construction of a sophisticated premarketing evaluation
    Masami Saito
    Kiyotaka Iwasaki
    Journal of Artificial Organs, 2017, 20 : 62 - 70
  • [8] Postmarketing Colitis Cases Associated With Alpelisib Use Reported to the US Food and Drug Administration
    Sullivan, Kathleen M.
    Dores, Graca M.
    Nayernama, Afrouz
    Prowell, Tatiana M.
    Pradhan, Shan M.
    Osgood, Christy
    Jones, S. Christopher
    JAMA ONCOLOGY, 2022, 8 (10) : 1503 - 1505
  • [9] US FOOD AND DRUG ADMINISTRATION (FDA) POSTMARKETING REQUIREMENTS AND COMMITMENTS RELATED TO DRUG DISPOSITION IN LACTATION AND PREGNANCY
    Ridge, S.
    Ramamoorthy, A.
    Guinn, D.
    Zineh, I.
    Fletcher, E. Pfuma
    CLINICAL PHARMACOLOGY & THERAPEUTICS, 2023, 113 : S77 - S77
  • [10] Reviewof the Drug Trials Snapshots Program of the US Food and Drug Administration: Women in Cardiovascular Drug Trials
    Whyte, John
    Woodcock, Janet
    Wang, Junyang
    JAMA INTERNAL MEDICINE, 2017, 177 (05) : 724 - 727
12345