Assessing a drug for an eradicated human disease: US Food and Drug Administration review of tecovirimat for the treatment of smallpox.
review · Level V
Where this comes from
- Record sourced from PubMed, PMID 30853252.
- Also identified by DOI 10.1016/S1473-3099(18)30788-6.
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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.
Medical subject headings
- Antiviral Agents
- Benzamides
- Drug Approval
- Isoindoles
- Smallpox