Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox

被引：28

作者：

Chan-Tack, Kirk M. ^{[1
]}

Harrington, Patrick R. ^{[1
]}

Choi, Su-Young ^{[2
]}

Myers, Laine ^{[1
]}

O'Rear, Julian ^{[1
]}

Seo, Shirley ^{[2
]}

McMillan, David ^{[1
]}

Ghantous, Hanan ^{[1
]}

Birnkrant, Debra ^{[1
]}

Sherwat, Adam, I ^{[1
]}

机构：

[1] US FDA, Ctr Drug Evaluat & Res, Div Antiviral Prod, Off Antimicrobial Prod, Silver Spring, MD 20993 USA

[2] US FDA, Ctr Drug Evaluat & Res, Off Translat Sci, Off Clin Pharmacol,Div Clin Pharmacol 4, Silver Spring, MD 20993 USA

来源：

LANCET INFECTIOUS DISEASES | 2019年 / 19卷 / 06期

关键词：

D O I：

10.1016/S1473-3099(18)30788-6

中图分类号：

R51 [传染病];

学科分类号：

100401 ;

摘要：

The development and ultimate approval of tecovirimat for the antiviral treatment of smallpox, a disease that has been eradicated from the world for nearly 40 years, required a unique regulatory approach based on the US Food and Drug Administration's Animal Rule. We summarise the regulatory pathway and describe the challenges involved.

引用

页码：E221 / E224

页数：4

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