Reflections on 10 years of the FDA’s breakthrough therapy designation

被引：0
|
作者：
Asher Mullard
机构：
来源：
Nature Reviews Drug Discovery | 2022年 / 21卷
关键词：
D O I：
暂无
中图分类号：
学科分类号：
摘要：
Ellen Sigal, the founder of Friends of Cancer Research, discusses the origins and future of the FDA’s breakthrough therapy designation as well as the changing patient advocacy landscape.
引用
收藏
页码：252 / 253
页数：1
相关论文
共 50 条
  • [21] FDA Breakthrough Therapy Designation: Evaluating the Quality of the Evidence behind the Drug Approvals
    Herink, Megan C.
    Irwin, Adriane N.
    Zumach, Gregory M.
    PHARMACOTHERAPY, 2018, 38 (09): : 967 - 980
  • [22] Physicians' Knowledge About FDA Approval Standards and Perceptions of the "Breakthrough Therapy" Designation
    Kesselheim, Aaron S.
    Woloshin, Steven
    Eddings, Wesley
    Franklin, Jessica M.
    Ross, Kathryn M.
    Schwartz, Lisa M.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2016, 315 (14): : 1516 - 1518
  • [23] Trends in breakthrough therapy designation
    Rachel R. Chizkov
    Ryan P. Million
    Nature Reviews Drug Discovery, 2015, 14 : 597 - 598
  • [24] Trends in breakthrough therapy designation
    Chizkov, Rachel R.
    Million, Ryan P.
    NATURE REVIEWS DRUG DISCOVERY, 2015, 14 (09) : 597 - 598
  • [25] FDA Breakthrough Therapy Designation Reduced Late-Stage Drug Development Time
    Miller, Kathleen L.
    Stern, Ariel D.
    Kearsley, Aaron
    Kao, Jennifer
    HEALTH AFFAIRS, 2024, 43 (07) : 1003 - 1010
  • [26] Clinical Trial Evidence Supporting FDA Approval of Drugs Granted Breakthrough Therapy Designation
    Puthumana, Jeremy
    Wallach, Joshua D.
    Ross, Joseph S.
    JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 2018, 320 (03): : 301 - 303
  • [27] Breakthrough Therapy Designation: CDER Analysis of Requests 4 Years Into the Program
    Conrad, Ryan
    Taylor, Kimberly
    Raggio, Miranda
    Harrington, Afi
    Stark, Grace
    Kish, Andrew
    Bertha, Amy
    THERAPEUTIC INNOVATION & REGULATORY SCIENCE, 2017, 51 (04) : 509 - 515
  • [28] Breakthrough Therapy Designation: CDER Analysis of Requests 4 Years Into the Program
    Ryan Conrad
    Kimberly Taylor
    Miranda Raggio
    Afi Harrington
    Grace Stark
    Andrew Kish
    Amy Bertha
    Therapeutic Innovation & Regulatory Science, 2017, 51 : 509 - 515
  • [29] Comment on FDA's Breakthrough Therapy Designation of Intranasal Esketamine for the Treatment of Major Depressive Disorder with Imminent Risk of Suicide
    Thomas, Reji
    Cetin, Mesut
    Baker, Glen B.
    Dursun, Serdar M.
    KLINIK PSIKOFARMAKOLOJI BULTENI-BULLETIN OF CLINICAL PSYCHOPHARMACOLOGY, 2016, 26 (04): : 329 - 331
  • [30] 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
    JOURNAL OF CLINICAL ONCOLOGY, 2014, 32 (15)
12345