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

Submitted by [email protected] on Thu, 03/07/2019 - 12:00 PM


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.

Content Source: Lancet

Content Author: Kirk M Chan-Tack, Patrick R Harrington, Su-Young Choi