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Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox.
- Source :
-
Lancet Infectious Diseases . Jun2019, Vol. 19 Issue 6, pe221-e224. 4p. - Publication Year :
- 2019
-
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. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 14733099
- Volume :
- 19
- Issue :
- 6
- Database :
- Academic Search Index
- Journal :
- Lancet Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 136582564
- Full Text :
- https://doi.org/10.1016/S1473-3099(18)30788-6