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Review
. 2019 Jun;19(6):e221-e224.
doi: 10.1016/S1473-3099(18)30788-6. Epub 2019 Mar 7.

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

Kirk M Chan-Tack  1 , Patrick R Harrington  2 , Su-Young Choi  3 , Laine Myers  2 , Julian O'Rear  2 , Shirley Seo  3 , David McMillan  2 , Hanan Ghantous  2 , Debra Birnkrant  2 , Adam I Sherwat  2
Affiliations
Review

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

Kirk M Chan-Tack et al. Lancet Infect Dis. 2019 Jun.

Abstract

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.

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