Breakthrough-Therapy Designation - An FDA Perspective

被引：12
|
作者：
Corrigan-Curay, Jacqueline [1 ]
Mckee, Amy E. [1 ]
Stein, Peter [1 ]
机构：
[1] US FDA, Silver Spring, MD 20993 USA
来源：
NEW ENGLAND JOURNAL OF MEDICINE | 2018年 / 378卷 / 15期
关键词：
D O I：
10.1056/NEJMc1801222
中图分类号：
R5 [内科学];
学科分类号：
1002 ; 100201 ;
摘要：
引用
收藏
页码：1457 / 1458
页数：2
相关论文
共 50 条
  • [21] IS FDA'S BREAKTHROUGH THERAPY DESIGNATION A GAME-CHANGING TREND FOR PATIENTS AND PAYERS?
    Aggarwal, S.
    Topaloglu, H.
    [J]. VALUE IN HEALTH, 2014, 17 (03) : A10 - A10
  • [22] Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation
    Puthumana, Jeremy
    Wallach, Joshua D.
    Ross, Joseph S.
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2018, 320 (03): : 301 - 303
  • [23] FDA breakthrough therapy designation of oncology-products: The first-year experience.
    Ning, Yangmin M.
    Kim, Tamy
    Maher, Virginia Ellen
    Ibrahim, Amna
    Murgo, Anthony J.
    Farrell, Ann T.
    Keegan, Patricia
    Justice, Robert L.
    Pazdur, Richard
    [J]. JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (15)
  • [24] Two cancer immunotherapeutics received FDA's breakthrough designation
    不详
    [J]. HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2015, 11 (04) : 809 - 809
  • [25] Caution urged over the FDA's new breakthrough designation
    Kevin Jiang
    [J]. Nature Medicine, 2013, 19 : 1196 - 1196
  • [26] The FDA Breakthrough-Drug Designation - Four Years of Experience
    Darrow, Jonathan J.
    Avorn, Jerry
    Kesselheim, Aaron S.
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2018, 378 (15): : 1444 - 1453
  • [27] Caution urged over the FDA's new breakthrough designation
    Jiang, Kevin
    [J]. NATURE MEDICINE, 2013, 19 (10) : 1196 - 1196
  • [28] Erratum: Trends in breakthrough therapy designation
    Rachel R. Chizkov
    Ryan P. Million
    [J]. Nature Reviews Drug Discovery, 2016, 15 : 216 - 216
  • [29] Australian access to FDA-approved breakthrough therapy designation medicines: a 10-year review
    Lingaratnam, Senthil
    Hussainy, Safeera Yasmeen
    Murphy, Alexandra
    Perrin, Cale
    Samuvel, Melbin
    Mehrvarz, Elahe
    Lim, Chiao Xin
    Zalcberg, John
    [J]. JOURNAL OF PHARMACEUTICAL POLICY AND PRACTICE, 2024, 17 (01)
  • [30] FDA Approves Sovaldi for Chronic Hepatitis C (Drug Is Third With Breakthrough Therapy Designation to Receive Such Approval)
    不详
    [J]. CLINICAL INFECTIOUS DISEASES, 2014, 58 (05) : I - I
12345