Accelerated Approval - Taking the FDA's Concerns Seriously

被引：14

作者：

Sachs, Rachel E. ^{[1
]}

Donohue, Julie M. ^{[2
]}

Dusetzina, Stacie B. ^{[3
,4
]}

机构：

[1] Washington Univ, Sch Law, St Louis, MO 63110 USA

[2] Univ Pittsburgh, Grad Sch Publ Hlth, Dept Hlth Policy & Management, Pittsburgh, PA USA

[3] Vanderbilt Univ, Sch Med, Dept Hlth Policy, Nashville, TN 37212 USA

[4] Vanderbilt Ingram Canc Ctr, Nashville, TN USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2022年 / 387卷 / 03期

关键词：

D O I：

10.1056/NEJMp2204487

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Accelerated Approval User-fee reauthorization creates new opportunities for the FDA to address issues with its accelerated-approval program, including the lack of evidence of clinical benefit for some products.

引用

页码：199 / 203

页数：5

共 50 条

[1] Surrogate endpoints and FDA's accelerated approval process
Fleming, TR
[J]. HEALTH AFFAIRS, 2005, 24 (01) : 67 - 78
[2] Modernising the US FDA's Accelerated Approval pathway
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Lythgoe, Mark P.
[J]. LANCET ONCOLOGY, 2023, 24 (03): : 203 - 205
[3] FDA accelerated approval under scrutiny
不详
[J]. JOURNAL OF INVESTIGATIVE MEDICINE, 2005, 53 (06) : 290 - 290
[4] FDA accelerated approval benefits glioblastoma
Cloughesy, Timothy
[J]. LANCET ONCOLOGY, 2010, 11 (12): : 1120 - 1120
[5] FDA accelerated approval of anticancer agents
Ning, Y. M.
Johnson, J. R.
Farrell, A. T.
Maher, V. E.
Justice, R. L.
Pazdur, R.
[J]. JOURNAL OF CLINICAL ONCOLOGY, 2010, 28 (15)
[6] FDA BREAKTHROUGH STATUS VERSUS ACCELERATED APPROVAL - WHAT'S THE DIFFERENCE?
Macaulay, R.
[J]. VALUE IN HEALTH, 2015, 18 (07) : A522 - A522
[7] Global consequences of the US FDA's accelerated approval of cancer drugs
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[8] FDA granted accelerated approval to ibrutinib(IMBRUVICA)
[J]. Journal of Chinese Pharmaceutical Sciences, 2014, (04) : 273 - 273
[9] The FDA Accelerated Drug Approval Program Explained
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[J]. US PHARMACIST, 2023, 48 (10) : 56 - 57
[10] FDA approval of umbralisib withdrawn due to safety concerns
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