Withdrawing Approval of Makena - A Proposal from the FDA Center for Drug Evaluation and Research

被引:28
|
作者
Chang, Christina Y. [1 ]
Nguyen, Christine P. [1 ]
Wesley, Barbara [1 ]
Guo, Jia [1 ]
Johnson, Laura Lee [1 ]
Joffe, Hylton V. [1 ]
机构
[1] US FDA, Ctr Drug Evaluat & Res, Silver Spring, MD 20993 USA
来源
NEW ENGLAND JOURNAL OF MEDICINE | 2020年 / 383卷 / 24期
关键词
D O I
10.1056/NEJMp2031055
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
[No abstract available]
引用
收藏
页数:4
相关论文
共 50 条
  • [2] FDA Revokes Approval for Preterm Birth Drug Makena
    Harris, Emily
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2023, 329 (17): : 1444 - 1444
  • [3] Diversity, equity, and inclusion in genitourinary clinical trials leading to FDA novel drug approval: An assessment of the FDA center for drug evaluation and research drug trials snapshot
    Matthew-Onabanjo, Asia N.
    Nortey, Gabrielle
    Matulewicz, Richard S.
    Basak, Ramsankar
    Culton, Donna A.
    Weaver, Kimberly N.
    Gallagher, Kristalyn K.
    Tan, Hung-Jui
    Rose, Tracy L.
    Milowsky, Matthew
    Bjurlin, Marc A.
    [J]. CURRENT PROBLEMS IN CANCER, 2023, 47 (03)
  • [4] FDA DRUG APPROVAL PACKAGES IN RESEARCH You can now search FDA approval documents easily at fda.opentrials.net
    Goldacre, Ben
    Turner, Erick
    [J]. BMJ-BRITISH MEDICAL JOURNAL, 2017, 356
  • [5] Career opportunities for chemists at FDA'S Center for Drug Evaluation and Research.
    Sheinin, EB
    [J]. ABSTRACTS OF PAPERS OF THE AMERICAN CHEMICAL SOCIETY, 2000, 220 : U219 - U219
  • [6] How to access and process FDA drug approval packages for use in research
    Turner, Erick H.
    [J]. BMJ-BRITISH MEDICAL JOURNAL, 2013, 347
  • [7] COVID-19 emergency responders in FDA's Center for Drug Evaluation and Research
    Gormley, Lieutenant Commander Andrea
    Ngan, Commander Kelly
    [J]. JOURNAL OF THE AMERICAN PHARMACISTS ASSOCIATION, 2020, 60 (03) : 527 - 528
  • [8] In silico toxicology: Predictive methods and applied regulatory research at the US FDA Center for Drug Evaluation and Research
    Valerio, L., Jr.
    [J]. TOXICOLOGY LETTERS, 2010, 196 : S26 - S26
  • [9] An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research: 2003 Through 2014
    Khushboo Sharma
    Afi Harrington
    Sallamar Worrell
    Amy Bertha
    [J]. Therapeutic Innovation & Regulatory Science, 2016, 50 : 697 - 704
  • [10] An FDA Analysis of Formal Dispute Resolution in the Center for Drug Evaluation and Research: 2003 Through 2014
    Sharma, Khushboo
    Harrington, Afi
    Worrell, Sallamar
    Bertha, Amy
    [J]. THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2016, 50 (06) : 697 - 704