Accelerated approval of medicines: fit for purpose?

被引：3
|
作者：
Breckenridge, Alasdair [1 ]
Liberti, Lawrence [2 ]
机构：
[1] Univ Liverpool, Dept Pharmacol & Therapeut, Ashton St, Liverpool L69 3BX, Merseyside, England
[2] Ctr Innovat Regulatory Sci, Friars House,160 Blackfriars Rd, London SE1 8EZ, England
来源：
NATURE REVIEWS DRUG DISCOVERY | 2018年 / 17卷 / 06期
关键词：
D O I：
10.1038/nrd.2017.245
中图分类号：
Q81 [生物工程学（生物技术）]; Q93 [微生物学];
学科分类号：
071005 ; 0836 ; 090102 ; 100705 ;
摘要：
The uptake of a new medicine represents a balance between benefit-risk assessment and value considerations. In the case of products approved via accelerated pathways, the increased uncertainty adds to the challenge. Here, we suggest solutions so that regulators, companies, payers and patients can align around management of the uncertainties and expectations.
引用
收藏
页码：379 / 380
页数：2
相关论文
共 50 条
  • [1] Accelerated approval of medicines: fit for purpose?
    Alasdair Breckenridge
    Lawrence Liberti
    [J]. Nature Reviews Drug Discovery, 2018, 17 : 379 - 380
  • [2] Section 12 approval: fit for purpose?
    Gupta, Nidhi
    Calthorpe, William
    [J]. BJPSYCH BULLETIN, 2020, 44 (03): : 125 - 126
  • [3] Section 12 approval: fit for purpose?
    Rigby, David
    McAlpine, Lynsey
    [J]. BJPSYCH BULLETIN, 2019, 43 (06): : 251 - 254
  • [4] TIME TO APPROVAL OF NOVEL CANCER MEDICINES GRANTED ACCELERATED APPROVAL AND IMPLICATIONS FOR REFORM OF THE ACCELERATED APPROVAL PATHWAY
    Hwang, Thomas
    Tibau, Ariadna
    [J]. JOURNAL OF UROLOGY, 2024, 211 (05): : E941 - E941
  • [5] Time to full approval of novel anticancer medicines granted accelerated approval and implications for reform of the accelerated approval pathway
    Hwang, T.
    Molto, C.
    Puy, M. Borrell
    Tibau, A.
    [J]. ANNALS OF ONCOLOGY, 2023, 34 : S931 - S931
  • [6] Reforms to accelerated approval of new medicines: long overdue
    Hwang, Thomas J.
    Quoc-Dien Trinh
    Tibau, Ariadna
    Vokinger, Kerstin N.
    [J]. LANCET, 2022, 400 (10349): : 357 - 358
  • [7] Section 12(2) MHA approval process is fit for purpose
    Khwaja, Masum
    [J]. BJPSYCH BULLETIN, 2020, 44 (03): : 126 - 127
  • [8] Section 12(2) MHA approval process is fit for purpose Reply
    Rigby, David
    McAlpine, Lynsey
    [J]. BJPSYCH BULLETIN, 2020, 44 (03): : 127 - 128
  • [9] ACCELERATED APPROVAL
    NIGHTINGALE, SL
    [J]. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION, 1992, 267 (24): : 3262 - 3262
  • [10] FIT for purpose
    Howson, William
    Smith, Geoff
    Martin, John
    [J]. CLINICAL MEDICINE, 2019, 19 (03) : 200 - 200
12345