The Impact of Breakthrough Therapy Designation on Development Strategies and Timelines for Nononcology Drugs and Vaccines

被引：11
|
作者：
Poirier, A. F. [1 ]
Murphy, W. R. [1 ]
机构：
[1] Pfizer US Regulatory Policy & Global Intelligence, Groton, CT USA
来源：
CLINICAL PHARMACOLOGY & THERAPEUTICS | 2016年 / 100卷 / 06期
关键词：
D O I：
10.1002/cpt.447
中图分类号：
R9 [药学];
学科分类号：
1007 ;
摘要：
The US Food and Drug Administration (FDA) Safety and Innovation Act (FDASIA, 2012) introduced the Breakthrough Therapy Designation (BTD), a new tool to expedite development of medicines to treat serious or life-threatening diseases. The majority of BTDs have gone to oncology drugs, and a recent publication by Shea et al.(1) reviewed the impact of BTD on oncology drug development. This article reviews the impact of BTD on development strategies and timelines for nononcology drugs.
引用
收藏
页码：603 / 605
页数：3
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  • [1] Influence of Breakthrough Therapy Designation in the United States on Oncology Drug Development Timelines in Japan
    Tanaka M.
    Matsumaru N.
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    [J]. Pharmaceutical Medicine, 2018, 32 (3) : 201 - 207
  • [2] Impact of breakthrough therapy designation on cancer drug development
    Michael Shea
    Linda Ostermann
    Ryan Hohman
    Samantha Roberts
    Marina Kozak
    Ryan Dull
    Jeff Allen
    Ellen Sigal
    [J]. Nature Reviews Drug Discovery, 2016, 15 : 152 - 152
  • [3] Impact of breakthrough therapy designation on cancer drug development
    Shea, Michael
    Ostermann, Linda
    Hohman, Ryan
    Roberts, Samantha
    Kozak, Marina
    Dull, Ryan
    Allen, Jeff
    Sigal, Ellen
    [J]. NATURE REVIEWS DRUG DISCOVERY, 2016, 15 (03) : 152 - 152
  • [4] The Impact of Breakthrough Therapy Designation on Development and Approval of Drugs and Biologics Intended for USE in Pediatric Cancer
    Casey, D.
    Barone, A.
    Marcus, L.
    Baird, K.
    Singh, S.
    Reaman, G.
    [J]. PEDIATRIC BLOOD & CANCER, 2020, 67 : S222 - S222
  • [5] Innovation in breakthrough drugs and vaccines: Development risk, patient impact, and value
    Prigodich, Andrew E.
    Wang, Shuntai
    Verhoest, Patrick
    Warne, Nicholas
    Allerton, Charlotte
    Burkhardt, John
    Fernando, Kathy
    Dolsten, Mikael
    [J]. DRUG DISCOVERY TODAY, 2021, 26 (10) : 2232 - 2237
  • [6] Two Meningococcal B vaccines receive FDA, Breakthrough Therapy' designation
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    [J]. HUMAN VACCINES & IMMUNOTHERAPEUTICS, 2014, 10 (06) : 1428 - 1429
  • [7] Drug Development in Serious Diseases: The New "Breakthrough Therapy" Designation
    Woodcock, J.
    [J]. CLINICAL PHARMACOLOGY & THERAPEUTICS, 2014, 95 (05) : 483 - 485
  • [8] Expediting Drug Development - The FDA's New "Breakthrough Therapy" Designation
    Sherman, Rachel E.
    Li, Jun
    Shapley, Stephanie
    Robb, Melissa
    Woodcock, Janet
    [J]. NEW ENGLAND JOURNAL OF MEDICINE, 2013, 369 (20): : 1877 - 1880
  • [9] Accelerated Approval and Breakthrough Therapy Designation: Oncology Drug Development on Speed?
    Yao, James C.
    Meric-Bernstam, Funda
    Lee, J. Jack
    Eckhardt, S. Gail
    [J]. CLINICAL CANCER RESEARCH, 2013, 19 (16) : 4305 - 4308
  • [10] 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
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